Evidence map›Paper›PMID 36171959›Full record

ArticleResearch and practice in thrombosis and haemostasis2022

Untreated bleeds in people with hemophilia A in a noninterventional study and intrapatient comparison after initiating emicizumab in HAVEN 1-3.

Michael U Callaghan, Elina Asikanius, Michaela Lehle, Johannes Oldenburg, Johnny Mahlangu, Marianne Uguen, Sammy Chebon, Rebecca Kruse-Jarres, Víctor Jiménez-Yuste, Midori Shima and 5 more

Open access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.3field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

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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

15 authors at 12 institutions in 8 countries.

Michael U CallaghanDepartment of Pediatrics Central Michigan University Detroit Michigan USA.
Elina AsikaniusProduct Development, F. Hoffmann-La Roche Ltd Basel Switzerland.
Michaela LehleProduct Development, F. Hoffmann-La Roche Ltd Basel Switzerland.
Johannes OldenburgInstitute of Experimental Haematology and Transfusion Medicine University of Bonn Bonn Germany.
Johnny MahlanguHaemophilia Comprehensive Care Centre, Faculty of Health Sciences University of the Witwatersrand and NHLS Johannesburg South Africa.
Marianne UguenPDB Biostatistics, F. Hoffmann-La Roche Ltd Basel Switzerland.
Sammy ChebonPDB Biostatistics, F. Hoffmann-La Roche Ltd Basel Switzerland.
Rebecca Kruse-JarresUniversity of Washington and Washington Center For Bleeding Disorders Seattle Washington USA.
Víctor Jiménez-YusteDepartment of Hematology La Paz Hospital, Autónoma University Madrid Spain.
Midori ShimaDepartment of Pediatrics Nara Medical University Kashihara Japan.ORCID https://orcid.org/0000-0002-5922-7061
Peter TraskPatient Centered Outcomes Research, Genentech, Inc. South San Francisco California USA.
Christine L KemptonDepartment of Hematology and Medical Oncology and Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory Emory University School of Medicine Atlanta Georgia USA.ORCID https://orcid.org/0000-0002-2391-2016
Craig M KesslerThe Division of Coagulation Georgetown University Hospital Washington District of Columbia USA.
Gallia G LevyProduct Development, Genentech, Inc. South San Francisco California USA.
Flora PeyvandiFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center Milan Italy.ORCID https://orcid.org/0000-0001-7423-9864
Roche (Switzerland) · CHCentral Michigan University · USEmory University · USGeorge Washington University Hospital · USHospital Universitario La Paz · ESNara Medical University · JPPatient-Centered Outcomes Research Institute · USSpark Therapeutics (United States) · USUniversity of Bonn · DEUniversity of Milan · ITUniversity of the Witwatersrand · ZAUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Bleeding in people with hemophilia A can be life threatening, and intra-articular bleeds can result in joint damage. Most clinical studies focus on treated bleeds, while bleeds not treated with coagulation factor(s) (untreated bleeds) are underreported. Objectives: We assessed the incidence of untreated bleeds during a noninterventional study (NIS) wherein people with hemophilia A, with or without factor VIII (FVIII) inhibitors, were managed according to standard practice. Patients/Methods: Using the Bleed and Medication Questionnaire, we prospectively collected data from three cohorts: Cohort A, adults/adolescents (age ≥12 years) with FVIII inhibitors; Cohort B, children (aged <12 years) with FVIII inhibitors; Cohort C, adults/adolescents without FVIII inhibitors. Untreated bleeds were analyzed for site, frequency, and etiology of bleeding and compared with those during emicizumab prophylaxis in the same individuals after transferring to a Phase III HAVEN trial. Results: In the 221 participants enrolled in the NIS (Cohort A, Conclusion: A significant proportion of bleeding events are untreated in people with hemophilia A. There is a need to further understand why bleeds remain untreated and to capture such events in clinical studies.

Indexed as

bleedingfactor VIIIhemophilia Ahemostasisprophylaxis

Identifiers

PMID36171959
PMCPMC9468791
OpenAlexW4296011290

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.