Evidence map›Paper›PMID 28693366›Full record

Trial reportThe New England journal of medicine2017

Idarucizumab for Dabigatran Reversal - Full Cohort Analysis.

Charles V Pollack, Paul A Reilly, Joanne van Ryn, John W Eikelboom, Stephan Glund, Richard A Bernstein, Robert Dubiel, Menno V Huisman, Elaine M Hylek, Chak-Wah Kam and 11 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02104947 (A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab), which is not on this map. Cited by 343 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
343citing papers in PubMed, 21 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02104947 phase3completednot on this map

A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

TypeinterventionalSponsorBoehringer IngelheimRan2014 to 2016Enrolled503ConditionsHemorrhageArmsidarucizumab
3 · Its place in the literature

Who cites it

343 citing papers in PubMed, 21 syntheses or guidelines pooled it.

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  9. Optimal management of cardiac surgery patients using direct oral anticoagulants: recommendations for clinical practice.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2023
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  14. Direct oral anticoagulants for venous thromboembolism in cancer patients: a systematic review and network meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
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283 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Charles V PollackFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Paul A ReillyFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Joanne van RynFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
John W EikelboomFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Stephan GlundFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Richard A BernsteinFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Robert DubielFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Menno V HuismanFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Elaine M HylekFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Chak-Wah KamFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Pieter W KamphuisenFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Jörg KreuzerFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Jerrold H LevyFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Gordon RoyleFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Frank W SellkeFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Joachim StangierFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Thorsten SteinerFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Peter VerhammeFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Bushi WangFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Laura YoungFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).
Jeffrey I WeitzFrom Thomas Jefferson University, Philadelphia (C.V.P.); Boehringer Ingelheim, Ridgefield, CT (P.A.R., R.D., B.W.); Boehringer Ingelheim, Biberach (J.R., S.G., J.S.), Boehringer Ingelheim, Ingelheim am Rhein (J.K.), Klinikum Frankfurt Höchst, Frankfurt (T.S.), and Heidelberg University Hospital, Heidelberg (T.S.) - all in Germany; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E., J.I.W.); Feinberg School of Medicine, Northwestern University, Chicago (R.A.B.); Leiden University Medical Center, Leiden (M.V.H.), and Tergooi Hospital, Hilversum (P.W.K.) - both in the Netherlands; Boston University School of Medicine, Boston (E.M.H.); Tuen Mun Hospital, Hong Kong (C.-W.K.); Duke University School of Medicine, Durham, NC (J.H.L.); Middlemore Hospital (G.R.) and the University of Auckland (L.Y.) - both in Auckland, New Zealand; Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence (F.W.S.); and KU Leuven, Center for Molecular and Vascular Biology, Leuven, Belgium (P.V.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIdarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran.

methodsWe performed a multicenter, prospective, open-label study to determine whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding (group A) or were about to undergo an urgent procedure (group B). The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the diluted thrombin time or ecarin clotting time. Secondary end points included the restoration of hemostasis and safety measures.

resultsA total of 503 patients were enrolled: 301 in group A, and 202 in group B. The median maximum percentage reversal of dabigatran was 100% (95% confidence interval, 100 to 100), on the basis of either the diluted thrombin time or the ecarin clotting time. In group A, 137 patients (45.5%) presented with gastrointestinal bleeding and 98 (32.6%) presented with intracranial hemorrhage; among the patients who could be assessed, the median time to the cessation of bleeding was 2.5 hours. In group B, the median time to the initiation of the intended procedure was 1.6 hours; periprocedural hemostasis was assessed as normal in 93.4% of the patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%. At 90 days, thrombotic events had occurred in 6.3% of the patients in group A and in 7.4% in group B, and the mortality rate was 18.8% and 18.9%, respectively. There were no serious adverse safety signals.

conclusionsIn emergency situations, idarucizumab rapidly, durably, and safely reversed the anticoagulant effect of dabigatran. (Funded by Boehringer Ingelheim; RE-VERSE AD ClinicalTrials.gov number, NCT02104947 .).

Indexed as

AdultAgedAged, 80 and overAntibodiesAntibodies, Monoclonal, HumanizedAnticoagulantsBlood CoagulationDabigatranDrug HypersensitivityFemaleHemorrhageHumansInfusions, IntravenousMaleMiddle AgedProspective StudiesAntibodiesAntibodies, Monoclonal, HumanizedAnticoagulantsDabigatranidarucizumab

Identifiers

PMID28693366

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.