THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)

NCT05033314 | Terminated Phase 3 DMC

• 1 other identifier: 20-5846.0
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

Research Question: In adult SCD patients with CVC, is it feasible and safe to conduct an adequately powered RCT to evaluate the use of rivaroxaban as thromboprophylaxis in this population? Study Design: The study is a vanguard pilot double blind multi-centre randomized controlled trial. Participants with SCD and CVC will be randomized to either rivaroxaban 10mg PO daily or placebo for the duration of CVC in situ or for up to one year, whichever is less. After screening (day -7 to day -1), patients will be followed at day 1, months 3 (+/- 15 days), 6 (+/- 15 days), 9 (+/- 15 days), and 12 (+/- 15 days). Study Objectives: The primary objective is to estimate the proportion of eligible patients who will enroll into a trial of thromboprophylaxis. Secondary objectives include (a) document indications for central venous catheter (CVC), (b) summarize duration of CVC insertion prior to enrollment, (c) estimate adherence to the study drug, (d) estimate proportions of participants being compliant with study procedures, and lost to follow up. Exploratory objectives will assess thrombotic, bleeding, and quality of life outcomes.

Conditions

Sickle Cell Disease; Central Venous Catheter Thrombosis; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• The proportion of eligible patients who will enroll into a trial of thromboprophylaxis

  1 year

Secondary Outcomes (4)

• Document indications for central venous catheter (CVC)

  1 year

• Summarize duration of CVC insertion prior to enrollment

  1 year

• Estimate adherence to the study drug

  1 year

• Estimate participants compliance with study procedures, and lost to follow up

  1 year

Other Outcomes (9)

• Venous thromboembolism (VTE)

  1 year

• Major bleeding or clinically relevant non-major bleeding

  1 year

• Major bleeding

  1 year

Study Arms (2)

Rivaroxaban thromboprophylaxis

EXPERIMENTAL

Drug: Rivaroxaban 10 MG

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rivaroxaban 10 MG DRUG

Rivaroxaban 10mg PO daily as thromboprophylaxis

Also known as: Xarelto 10mg

Rivaroxaban thromboprophylaxis

Placebo DRUG

matching placebo daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age 18 or older)
• Documented SCD
• New or pre-existing CVC planned for long term use (at least 6 months)
• Able to provide written consent

You may not qualify if:

• Contra-indication to prophylactic dose anticoagulation or active bleeding at discretion of treating physician
• Already on anticoagulation (prophylactic or therapeutic dose) for an indication other than CVC thromboprophylaxis
• Previous VTE within the past 3 months
• Pregnant, within 6 weeks post-partum, or active breast feeding
• Creatinine clearance \<30mL/min (as calculated by Cockcroft-Gault equation\[67\])
• Acute hepatitis or chronic active hepatitis
• Cirrhosis with Child-Pugh score B or C
• Platelet count \< 50 x109/L
• Weight \<40kg
• Uncontrolled HTN (systolic blood pressure \> 170mmhg, or diastolic blood pressure\> 100mmhg) despite antihypertensive treatment
• On palliative care
• On dual antiplatelet therapy, or high dose single agent aspirin \> 325mg/day
• On combined P-glycoprotein and strong cytochrome P450 3A4 inhibitors (including but not limited to ketoconazole and protease inhibitors)
• On combined P-glycoprotein and strong cytochrome P450 3A4 inducers (including but not limited to rifampin, phenytoin, phenobarbital, carbamazepine, and st. john's wort)
• Active cancer or treatment for cancer excluding basal cell carcinoma

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• Abdulrehman J, Forte S, Tomlinson G, Solh Z, Bolster L, Sun HL, Kuo KHM. Challenges in Trials in Sickle Cell Disease: Thromboprophylaxis in Sickle Cell Disease With Central Venous Catheters (THIS) Pilot Study. J Clin Apher. 2025 Dec;40(6):e70072. doi: 10.1002/jca.70072.

  PMID: 41249873 DERIVED

• Abdulrehman J, Forte S, Tomlinson G, Solh Z, Bolster L, Sun HL, Bartolucci P, Kuo KHM. THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol. BMJ Open. 2024 Jan 3;14(1):e079363. doi: 10.1136/bmjopen-2023-079363.

  PMID: 38171625 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Upper Extremity Deep Vein Thrombosis; Venous Thromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: September 2, 2021
• Study Start: June 7, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)