Evidence map›Paper›PMID 34703348›Full record

ArticleJournal of blood medicine2021

A Prospective Observational Study of Antihemophilic Factor (Recombinant) Prophylaxis Related to Physical Activity Levels in Patients with Hemophilia A in the United States (SPACE).

Barbara A Konkle, Doris V Quon, Leslie Raffini, Michael Recht, Vlad C Radulescu, Shannon L Carpenter, Amy L Dunn, Mei Lu, Maureen Watt

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of blood medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02190149 (Study of Prophylaxis, ACtivity and Effectiveness), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 36% 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.

NCT02190149 completednot on this map

Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS

TypeobservationalSponsorBaxalta now part of ShireRan2014 to 2016Enrolled64ConditionsHemophilia A, Hemophilia BArmsADVATE (Antihemophilic Factor [Recombinant]), RIXUBIS (Coagulation Factor IX [Recombinant])
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

9 authors at 9 institutions in 2 countries.

Barbara A KonkleDepartment of Medicine, The University of Washington and Bloodworks Northwest, Seattle, WA, USA.
Doris V QuonOrthopaedic Hemophilia Treatment Center, Orthopaedic Institute for Children, Los Angeles, CA, USA.
Leslie RaffiniDivision of Hematology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Michael RechtThe Hemophilia Center, Oregon Health & Science University, Portland, OR, USA.ORCID 0000-0002-2805-1016
Vlad C RadulescuDepartment of Pediatric Hematology and Oncology, University of Kentucky Medical Center, Lexington, KY, USA.
Shannon L CarpenterDepartment of Hematology/Oncology, Children's Mercy Hospital, Kansas City, MO, USA.
Amy L DunnHemophilia Treatment Center, Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus, OH, USA.
Mei LuTakeda Development Center Americas, Inc, Lexington, MA, USA.
Maureen WattOutcomes Research & Epidemiology, Takeda Pharmaceuticals International AG, Zurich, Switzerland.
Children's Hospital of Philadelphia · USChildren's Mercy Hospital · USNationwide Children's Hospital · USOregon Health & Science University · USOrthopaedic Institute for Children · USTakeda (Switzerland) · CHTakeda (United States) · USUniversity of Kentucky · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHigh collision-risk physical activity can increase bleeding risk in people with hemophilia A, as can increasing the time between factor VIII (FVIII) administration and physical activity. FVIII prophylaxis may be tailored to planned activities to prevent activity-related bleeding.

aimTo explore the relationship between physical activity levels, FVIII infusion timing, and occurrence of bleeding in patients with severe/moderately severe hemophilia A without FVIII inhibitors receiving antihemophilic factor (recombinant) (rAHF; ADVATE

methodsSPACE was a 6-month, prospective, multicenter, observational outcomes study (NCT02190149). Enrolled patients received an eDiary application and a wearable activity tracker, which recorded physical activity, rAHF infusion, and occurrence of bleeding. Physical activity risks were ranked using National Hemophilia Foundation criteria.

resultsFifty-four patients aged 11-58 years (n = 47 prophylaxis, n = 7 on-demand) were included in the analysis. Patients had a mean (SD) 8.14 (10.94) annualized bleeding rate, and recorded 4980 intervals between an rAHF infusion and physical activity; 1759 (35.3%) of these intervals were ≤24 hours. Analysis of recorded eDiary data showed that the risk of activity-related bleeding did not significantly increase with time between last infusion and activity, but did increase with higher-risk physical activities. Analysis of activity tracker recorded data showed that the risk of bleeding reported by patients as spontaneous increased with prolonging time (≤24 to >24 hours) from last infusion to physical activity start (odds ratio 2.65,

conclusionThese results show that activities with a high risk of collision lead to an increased risk of bleeding. Further investigation is warranted to explore potential benefits of FVIII infusion timing to reduce the risks of activity-related occurrence of bleeding.

Indexed as

bleedinghemophilia Aphysical activitypost-authorization studyprophylaxisrecombinant factor VIII

Identifiers

PMID34703348
PMCPMC8523903
OpenAlexW3206154765

What OpenQuestion holds

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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.