Evidence map›Paper›PMID 37694269›Full record

ArticleResearch and practice in thrombosis and haemostasis2023

Recombinant factor IX Fc for major surgery in hemophilia B: factor IX plasma activity levels and effective hemostasis.

Amy D Shapiro, Hervé Chambost, Margareth C Ozelo, Aletta Falk, Helena Ahlin, Sandra Casiano, Elena Santagostino

Open access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 27% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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 6 institutions in 5 countries.

Amy D ShapiroIndiana Hemophilia and Thrombosis Center, Indianapolis, Indiana, USA.
Hervé ChambostAP-HM, Paediatric Haematology Department, Children's Hospital La Timone and Aix Marseille University, C2VN, Marseille, France.
Margareth C OzeloHemocentro UNICAMP, University of Campinas, Campinas, São Paulo, Brazil.
Aletta FalkSwedish Orphan Biovitrum AB, Stockholm, Sweden.
Helena AhlinSwedish Orphan Biovitrum AB, Stockholm, Sweden.
Sandra CasianoSanofi, Waltham, Massachusetts, USA.
Elena SantagostinoSwedish Orphan Biovitrum AG, Basel, Switzerland.
Swedish Orphan Biovitrum (Sweden) · SEAix-Marseille Université · FRIndiana Hemophilia and Thrombosis Center · USSanofi (United States) · USSwedish Orphan Biovitrum (Switzerland) · CHUniversidade Estadual de Campinas (UNICAMP) · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Major surgical procedures are associated with significant bleeding risk and infectious complications in patients with hemophilia, which may be minimized by factor replacement. Monitoring perioperative factor levels guides dosing to maintain adequate levels for hemostatic control. Objectives: We report prospectively collected post hoc surgical data in patients with hemophilia B who underwent major surgery with extended half-life recombinant factor IX Fc fusion protein (rFIXFc) in phase 3 studies (B-LONG/Kids B-LONG and B-YOND). Methods: Achieved FIX plasma levels were described for those who underwent major surgeries with ≥1 peak and/or predose FIX assessment available on the day of surgery (Day 0 [D0]) from the central laboratory. Dosing, injection frequency, adverse events, and hemostatic responses were assessed. Two representative cases were described further including blood loss, transfusions, and concomitant medication assessment. Results: Of 35 major surgeries, 17 ( Conclusion: The aggregate analysis and representative cases of major surgeries demonstrate that rFIXFc can achieve FIX levels for effective hemostasis during invasive high-risk procedures.

Indexed as

factor IXhemophilia Bhemostasisrecombinant fusion proteinssurgery

Identifiers

PMID37694269
PMCPMC10491823
OpenAlexW4385621403

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.