THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS) (THIS)
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|ClinicalTrials.gov Identifier: NCT05033314|
Recruitment Status : Not yet recruiting
First Posted : September 2, 2021
Last Update Posted : September 28, 2021
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?
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).
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.
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Central Venous Catheter Thrombosis Venous Thromboembolism||Drug: Rivaroxaban 10 MG Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS): A Pilot Study|
|Estimated Study Start Date :||November 1, 2021|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2024|
|Experimental: Rivaroxaban thromboprophylaxis||
Drug: Rivaroxaban 10 MG
Rivaroxaban 10mg PO daily as thromboprophylaxis
Other Name: Xarelto 10mg
|Placebo Comparator: Placebo||
matching placebo daily
- The proportion of eligible patients who will enroll into a trial of thromboprophylaxis [ Time Frame: 1 year ]
- Document indications for central venous catheter (CVC) [ Time Frame: 1 year ]
- Summarize duration of CVC insertion prior to enrollment [ Time Frame: 1 year ]
- Estimate adherence to the study drug [ Time Frame: 1 year ]
- Adherence: percentage of administered drugs not returned (by pill counting);
- Compliance: defined as percentage adherence >80%.
- Estimate participants compliance with study procedures, and lost to follow up [ Time Frame: 1 year ]Defined as proportion of participant lost to follow up or withdrawn from the study prior to completion of 6 months of treatment
- Venous thromboembolism (VTE) [ Time Frame: 1 year ]Proportion of participants with VTE (including CRT, right atrial or ventricular thrombus, proximal DVT, segmental PE, unusual site VTE), and unexplained death in which PE could not be ruled out. CRT is defined to include a proximal vein and must be the same limb as the CVC. Proximal veins include both lower and upper limb, and must include the popliteal or more proximal vein if lower limb, or axillary or more proximal. Unusual site VTE is defined to include cerebral vein thrombosis or splanchnic vein thrombosis. VTE must be objectively confirmed with appropriate imaging modalities.
- Major bleeding or clinically relevant non-major bleeding [ Time Frame: 1 year ]Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria
- Major bleeding [ Time Frame: 1 year ]Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria
- Clinically relevant non-major bleeding [ Time Frame: 1 year ]Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria
- Event-free survival [ Time Frame: 1 year ]Defined as free from VTE or major bleeding events
- Arterial thrombotic events [ Time Frame: 1 year ]Including myocardial infarction, ischemic stroke, and systemic embolism
- CVC change due to thrombosis or catheter occlusion not amenable to infusion of thrombolytics between study arms [ Time Frame: 1 year ]Proportion of participants requiring CVC change due to thrombosis or catheter occlusion not amenable to infusion of thrombolytics
- Quality of life using the modified Duke Anticoagulation Satisfaction Scale [ Time Frame: 1 year ]The modified Duke Anticoagulation Satisfaction Scale is a 14 item scale addressing the negative and positive impacts of anticoagulation with participants rating items as "strongly agree", "agree", "neither agree nor disagree", "disagree", or "strongly disagree"
- Bruising using a Likert scale [ Time Frame: 1 year ]A one item survey with the question "Over the past 3 months, have you noticed any abnormal bruising?" with response ranging from 0 (no bruising) to 10 (lots of bruising).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033314
|Contact: Ana Maria Gonzalezfirstname.lastname@example.org|