Evidence map›Paper›PMID 26037084›Full record

Trial reportJournal of the American Heart Association2015

Randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery.

Marco Ranucci, Ekaterina Baryshnikova, Giulia Beatrice Crapelli, Niels Rahe-Meyer, Lorenzo Menicanti, Alessandro Frigiola, Surgical Clinical Outcome REsearch (SCORE) Group

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 pooled it
12.7field-weighted citation impact, top 1% of its field
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.

NCT01471730 phase3completednot on this map

The ZEroPLASmaTrial (ZEPLAST): a Randomized, Controlled Trial on Transfusion Avoidance in High Transfusion-risk Cardiac Surgery Patients

TypeinterventionalSponsorIRCCS Policlinico S. DonatoRan2011 to 2014Enrolled119ConditionsHeart DiseaseArmsFibrinogen, Saline solution, Prothrombin complex
NCT04376762 phase4completednot on this mapstarted 2021, after this paper: background citation

Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients

TypeinterventionalSponsorUniversity of VirginiaRan2021 to 2023Enrolled31ConditionsPediatric HD, BleedingArmsFibrinogen, Cryoprecipitate
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 180 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Prophylactic Fibrinogen Decreases Postoperative Bleeding but Not Acute Kidney Injury in Patients Undergoing Heart Transplantation.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2018
    Trial
  6. Trial
  7. Trial
  8. Does Intraoperative Fibrinogen Affect Blood Loss or Transfusion Practice After Aortic Arch Surgery: A Prematurely Ended Randomized Trial.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Trial
  9. Review
  10. Article
  11. Observational
  12. Review
  13. Observational
  14. Observational
  15. Article
  16. Article
  17. 2024 EACTS/EACTAIC Guidelines on patient blood management in adult cardiac surgery in collaboration with EBCP.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2025
    Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Marco RanucciDepartment of Cardiothoracic, Vascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Milan, Italy (M.R., E.B., G.B.C.).
Ekaterina BaryshnikovaDepartment of Cardiothoracic, Vascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Milan, Italy (M.R., E.B., G.B.C.).
Giulia Beatrice CrapelliDepartment of Cardiothoracic, Vascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Milan, Italy (M.R., E.B., G.B.C.).
Niels Rahe-MeyerClinic for Anesthesiology and Intensive Care Medicine, Hannover Medical School, Hannover, Germany (N.R.M.).
Lorenzo MenicantiDepartment of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy (L.M., A.F.).
Alessandro FrigiolaDepartment of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy (L.M., A.F.).
Surgical Clinical Outcome REsearch (SCORE) Group
IRCCS Policlinico San Donato · ITMedizinische Hochschule Hannover · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative bleeding after heart operations is still a common finding, leading to allogeneic blood products transfusion. Fibrinogen and coagulation factors deficiency are possible determinants of bleeding. The experimental hypothesis of this study is that a first-line fibrinogen supplementation avoids the need for fresh frozen plasma (FFP) and reduces the need for any kind of transfusions. METHODS AND

resultsThis was a single-center, prospective, randomized, placebo-controlled, double-blinded study. One-hundred sixteen patients undergoing heart surgery with an expected cardiopulmonary bypass duration >90 minutes were admitted to the study. Patients in the treatment arm received fibrinogen concentrate after protamine administration; patients in the control arm received saline solution. In case of ongoing bleeding, patients in the treatment arm could receive prothrombin complex concentrates (PCCs) and those in the control arm saline solution. The primary endpoint was avoidance of any allogeneic blood product. Patients in the treatment arm had a significantly lower rate of any allogeneic blood products transfusion (odds ratio, 0.40; 95% confidence interval, 0.19 to 0.84, P=0.015). The total amount of packed red cells and FFP units transfused was significantly lower in the treatment arm. Postoperative bleeding was significantly (P=0.042) less in the treatment arm (median, 300 mL; interquartile range, 200 to 400 mL) than in the control arm (median, 355 mL; interquartile range, 250 to 600 mL).

conclusionsFibrinogen concentrate limits postoperative bleeding after complex heart surgery, leading to a significant reduction in allogeneic blood products transfusions. No safety issues were raised. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01471730.

Indexed as

AgedBlood Coagulation TestsBlood TransfusionCardiac Surgical ProceduresDouble-Blind MethodFemaleFibrinogenHumansMaleMiddle AgedPostoperative HemorrhageTreatment OutcomeFibrinogencardiopulmonary bypassfibrinogenhemorrhagesurgery

Identifiers

PMID26037084
PMCPMC4599543
OpenAlexW2113079267

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.