Evidence map›Paper›PMID 42290320›Full record

ArticleHaemophilia : the official journal of the World Federation of Hemophilia

Management of Breakthrough Bleeding During Emicizumab Prophylaxis in Acquired Haemophilia A: Data From the GTH-AHA-EMI Study.

Halet Türkantoz, Christiane Dobbelstein, Richard Greil, Christina Hart, Robert Klamroth, Paul Knöbl, Johannes Oldenburg, Christian Pfrepper, Ulrich Sachs, Inga M Schimansky and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Haemophilia : the official journal of the World Federation of Hemophilia. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04188639 (Emicizumab in Patients With Acquired Hemophilia A), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT04188639 phase2completednot on this map

Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial

TypeinterventionalSponsorGWT-TUD GmbHRan2021 to 2023Enrolled47ConditionsHemophilia A, AcquiredArmsEmicizumab Injection
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Halet TürkantozHematology, Haemostasis, Oncology, and Cell Therapy, Hannover Medical School, Hannover, Germany.
Christiane DobbelsteinHematology, Haemostasis, Oncology, and Cell Therapy, Hannover Medical School, Hannover, Germany.
Richard GreilIIIrd Medical Department, Salzburg Cancer Research Institute CCCIT; Cancer Cluster Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria.
Christina HartDepartment of Hematology and Oncology, University Hospital Regensburg, Regensburg, Germany.
Robert KlamrothInternal Medicine, Vascular Medicine and Coagulation Disorders, Vivantes Clinic Friedrichshain, Berlin, Germany.
Paul KnöblDepartment of Medicine 1, Div. Hematology and Hemostasis, Medical University of Vienna, Vienna, Austria.
Johannes OldenburgInstitute of Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Medical Faculty, University of Bonn, Bonn, Germany.ORCID https://orcid.org/0000-0002-1585-4100
Christian PfrepperDivision of Haemostaseology, Medical Department I, University Hospital Leipzig, Leipzig, Germany.ORCID https://orcid.org/0000-0002-0485-7402
Ulrich SachsDepartment of Thrombosis and Haemostasis, Giessen University Hospital, Giessen, Germany.ORCID https://orcid.org/0000-0001-5486-5542
Inga M SchimanskyHematology, Haemostasis, Oncology, and Cell Therapy, Hannover Medical School, Hannover, Germany.
Karolin Trautmann-GrillMedical Clinic I, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.
Andreas TiedeHematology, Haemostasis, Oncology, and Cell Therapy, Hannover Medical School, Hannover, Germany.ORCID https://orcid.org/0000-0002-3600-8536

Funding

Gesellschaft für Wissens- und TechnologietransferHoffman-La Roche
6 · The paper itself

Abstract

introductionThe GTH-AHA-EMI study showed that emicizumab reduces bleeding in patients with acquired haemophilia A (AHA). However, 22 clinically relevant new bleeds (CRNB) occurred in 14 of the 47 study patients, most of which required haemostatic treatment.

aimTo describe characteristics, treatment, and outcome of CRNB that occurred during the 12 weeks of haemostatic prophylaxis with emicizumab.

methodsData were extracted from the GTH-AHA-EMI study data base. Further information was collected retrospectively using a standardized questionnaire answered by study investigators.

resultsOf the 22 CRNB, 9 and 13 were classified as major and non-major, respectively. 15 bleeds occurred spontaneously, and 20 bleed required treatment. Recombinant factor VIIa was used for treatment in 16 of 20 treated bleeds, recombinant porcine factor VIII was used in three events. Eight patients were admitted to the hospital because of CRNB; extension of hospitalization was reported in 13 patients; 9 were admitted to an intensive care unit; invasive interventions were required in nine patients. Most bleeds were treated successfully; permanent harm from bleeding was reported in two patients. No thromboembolic events or other adverse events were reported.

conclusionAlthough emicizumab reduces bleeding in AHA, breakthrough bleeding can still occur, was often severe and required haemostatic treatment. Haemostatic treatment was safe and usually effective.

trial registrationNCT04188639.

Indexed as

Antibodies, BispecificAntibodies, Monoclonal, HumanizedHemophilia AHemorrhageAdultAgedFactor VIIaFemaleHumansMaleMiddle AgedRecombinant ProteinsRetrospective StudiesTreatment OutcomeYoung AdultAntibodies, BispecificAntibodies, Monoclonal, HumanizedemicizumabFactor VIIarecombinant FVIIaRecombinant Proteinsemicizumabfactor 8 deficiency acquiredhaemorrhagerecombinant factor VIIasafetytranexamic acid

Identifiers

PMID42290320
PMCPMC13551118

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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.