Evidence map›Paper›PMID 38171625›Full record

ArticleBMJ open2024

THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol.

Jameel Abdulrehman, Stephanie Forté, George Tomlinson, Ziad Solh, Lauren Bolster, Haowei Linda Sun, Pablo Bartolucci, Kevin H M Kuo

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05033314 (THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.8field-weighted citation impact, top 17% 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.

NCT05033314 phase3terminatednot on this map

THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS): A Pilot Study

TypeinterventionalSponsorUniversity Health Network, TorontoRan2022 to 2024Enrolled4ConditionsSickle Cell Disease, Central Venous Catheter Thrombosis, Venous ThromboembolismArmsRivaroxaban 10 MG, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Sickle cell disease: managing thromboembolism.Hematology. American Society of Hematology. Education Program · 2025
    Review
  3. Review
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

8 authors at 6 institutions in 3 countries.

Jameel AbdulrehmanDivision of Hematology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada Jameel.Abdulrehman@uhn.ca.ORCID 0000-0002-3648-2406
Stephanie FortéDivision of Hematology, Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
George TomlinsonInstitute for Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
Ziad SolhDivision of Transfusion Medicine, Department of Pathology and Laboratory Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
Lauren BolsterDivision of Hematology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Haowei Linda SunDivision of Hematology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Pablo BartolucciDepartment of Internal Medicine, Assistance Publique Hopitaux de Paris, Creteil, France.
Kevin H M KuoDivision of Hematology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
University of Alberta · CAUniversity of Toronto · CA3M (United States) · USAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier de l’Université de Montréal · CAWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIndividuals with sickle cell disease (SCD) and central venous catheters (CVC) are at high risk for venous thromboembolism (VTE). Minimal data exist regarding the use of anticoagulation as thromboprophylaxis of VTE in this demographic, and as a result, clinical equipoise exists. Prophylactic dose rivaroxaban, a direct oral anticoagulant, is efficacious and safe as thromboprophylaxis in other demographics, and may be an optimal agent in SCD with CVC. Prior to conducting a full clinical trial to assess rivaroxaban as thromboprophylaxis in SCD with CVC, a pilot study is needed to gauge its feasibility. METHODS AND ANALYSIS: THromboprophylaxis In Sickle Cell Disease pilot trial is an investigator-initiated, multicentre, double-blinded, randomised controlled trial (RCT) assessing if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to matching placebo as thromboprophylaxis in those with SCD and CVC. Fifty adult patients with SCD and CVC will be randomised to receive either rivaroxaban 10 mg daily or matching placebo for the duration of the CVC in situ for up to 1 year. After randomisation, follow-up visits will occur every 3 months. The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. Exploratory outcomes include overall incidence of VTE and bleeding complications, as well as quality of life. If the full trial is feasible, blinding will be maintained and patients in the pilot study will be included in the full trial. ETHICS AND DISSEMINATION: The trial was initially approved by the University Health Network Research Ethics Board (REB) in Toronto, Canada. All sites will obtain approval from their respective REB prior to commencement of study activities. Study results will be disseminated through presentations at medical conferences and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05033314.

Indexed as

Anemia, Sickle CellCentral Venous CathetersVenous ThromboembolismAdultAnticoagulantsHumansPilot ProjectsRandomized Controlled Trials as TopicRivaroxabanAnticoagulantsRivaroxabananaemiaanticoagulationrandomized controlled trialthromboembolismvascular medicine

Identifiers

PMID38171625
PMCPMC10773310
OpenAlexW4390595411

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.