Evidence map›Paper›PMID 40347118›Full record

ArticleHaemophilia : the official journal of the World Federation of Hemophilia2025

Efficacy and Safety of rVIII-SingleChain in Surgical Prophylaxis.

Faraizah Abdul Karim, Johnny Mahlangu, Claudia Djambas Khayat, Jeannie Ong, Stephanie P'Ng, Johannes Oldenburg, Cindy Leissinger, Samantha Lucas, Amy Suen, Blanca Salazar and 1 more

Abstract read
In one paragraph

Article in Haemophilia : the official journal of the World Federation of Hemophilia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Efficacy and Safety of rVIII-SingleChain in Surgical Prophylaxis.Haemophilia : the official journal of the World Federation of Hemophilia · 2025
    Article
  2. Observational
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

11 authors.

Faraizah Abdul KarimNational Blood Centre, Kuala Lumpur, Malaysia.
Johnny MahlanguUniversity of the Witwatersrand, NHLS and Charlotte Maxeke Hospital, Johannesburg, South Africa.
Claudia Djambas KhayatDepartment of Pediatrics, Hotel Dieu de France Saint Joseph University, Beirut, Lebanon.ORCID https://orcid.org/0000-0002-5584-5049
Jeannie OngBrokenshire Integrated, Davao City, Philippines.
Stephanie P'NgRoyal Perth Hospital, Perth, WA, Australia.ORCID https://orcid.org/0000-0001-7535-4100
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
Cindy LeissingerDepartments of Medicine, Pediatrics, and Pathology, Tulane University School of Medicine, New Orleans, Louisiana, USA.
Samantha LucasCSL Behring, King of Prussia, Pennsylvania, USA.
Amy SuenCSL Behring, King of Prussia, Pennsylvania, USA.
Blanca SalazarCSL Behring, King of Prussia, Pennsylvania, USA.
Ingrid PabingerClinical Division of Haematology and Haemostaseology, Department of Medicine, Medical University Vienna, Vienna, Austria.ORCID https://orcid.org/0000-0002-7677-9896

Funding

CSL Behring
6 · The paper itself

Abstract

introductionRVIII-SingleChain is a B-domain-truncated factor VIII construct with a covalent bond between the factor VIII heavy and light chains.

aimWe report on the efficacy and safety of rVIII-SingleChain in subjects with severe haemophilia A undergoing surgery.

methodsSurgery, elective or emergent, was defined as all procedures requiring general, spinal, or regional anaesthesia. rVIII-SingleChain was administered as a bolus or continuous infusion during the perioperative period, dosed individually at the discretion of the investigator based upon the type of surgery and clinical status of the patient. The investigator rated haemostatic efficacy on a 4-point scale (excellent, good, moderate or poor/no response), where treatment success was defined as excellent or good.

resultsOverall, 36 subjects underwent 48 surgeries: 41 surgeries in 30 adult/adolescent (mean age 34 [range 12-64] years) and 7 in 6 paediatric subjects (mean age 8 [5-11] years). rVIII-SingleChain was administered during 24 orthopaedic and 17 non-orthopaedic surgeries in adults/adolescents and 7 non-orthopaedic surgeries in paediatrics. Haemostatic efficacy was rated as excellent (n = 36, 88%) or good (n = 5, 12%) in adult/adolescent surgeries and as excellent (n = 7, 100%) in paediatric surgeries. In adults/adolescents, mean (standard deviation [SD]) blood loss was lower than predicted (68.6 [99.9] mL vs. 196.7 [292.8] mL); values were comparable in paediatric subjects (2.1 [2.7] mL vs. 2.9 [2.7] mL). No serious or related adverse events (AEs) were reported during the perioperative period.

conclusionPerioperative administration of rVIII-SingleChain effectively achieves and maintains haemostatic control in adult/adolescent and paediatric subjects with haemophilia A undergoing surgery.

Indexed as

Blood Loss, SurgicalFactor VIIIHemophilia AAdolescentAdultChildChild, PreschoolFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultFactor VIIIfactor VIIIhaemophilia Ahaemostasisperioperative periodsurgery

Identifiers

PMID40347118
PMCPMC12547194

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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.