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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05033314
Recruitment Status : Not yet recruiting
First Posted : September 2, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Kevin H.M. Kuo, MD, MSc, FRCPC, University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Central Venous Catheter Thrombosis Venous Thromboembolism Drug: Rivaroxaban 10 MG Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Rivaroxaban thromboprophylaxis Drug: Rivaroxaban 10 MG
Rivaroxaban 10mg PO daily as thromboprophylaxis
Other Name: Xarelto 10mg

Placebo Comparator: Placebo Drug: Placebo
matching placebo daily




Primary Outcome Measures :
  1. The proportion of eligible patients who will enroll into a trial of thromboprophylaxis [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Document indications for central venous catheter (CVC) [ Time Frame: 1 year ]
  2. Summarize duration of CVC insertion prior to enrollment [ Time Frame: 1 year ]
  3. Estimate adherence to the study drug [ Time Frame: 1 year ]
    1. Adherence: percentage of administered drugs not returned (by pill counting);
    2. Compliance: defined as percentage adherence >80%.

  4. 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


Other Outcome Measures:
  1. 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.

  2. Major bleeding or clinically relevant non-major bleeding [ Time Frame: 1 year ]
    Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria

  3. Major bleeding [ Time Frame: 1 year ]
    Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria

  4. Clinically relevant non-major bleeding [ Time Frame: 1 year ]
    Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria

  5. Event-free survival [ Time Frame: 1 year ]
    Defined as free from VTE or major bleeding events

  6. Arterial thrombotic events [ Time Frame: 1 year ]
    Including myocardial infarction, ischemic stroke, and systemic embolism

  7. 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

  8. 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"

  9. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Contra-indication to prophylactic dose anticoagulation or active bleeding at discretion of treating physician
  2. Already on anticoagulation (prophylactic or therapeutic dose) for an indication other than CVC thromboprophylaxis
  3. Previous VTE within the past 3 months
  4. Pregnant, within 6 weeks post-partum, or active breast feeding
  5. Creatinine clearance <30mL/min (as calculated by Cockcroft-Gault equation[67])
  6. Acute hepatitis or chronic active hepatitis
  7. Cirrhosis with Child-Pugh score B or C
  8. Platelet count < 50 x109/L
  9. Weight <40kg
  10. Uncontrolled HTN (systolic blood pressure > 170mmhg, or diastolic blood pressure> 100mmhg) despite antihypertensive treatment
  11. On palliative care
  12. On dual antiplatelet therapy, or high dose single agent aspirin > 325mg/day
  13. On combined P-glycoprotein and strong cytochrome P450 3A4 inhibitors (including but not limited to ketoconazole and protease inhibitors)
  14. On combined P-glycoprotein and strong cytochrome P450 3A4 inducers (including but not limited to rifampin, phenytoin, phenobarbital, carbamazepine, and st. john's wort)
  15. Active cancer or treatment for cancer excluding basal cell carcinoma
  16. Known allergy to study drug
  17. Strong indication for thromboprophylaxis at discretion of treating physician
  18. Significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data.

Information from the National Library of Medicine

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


Contacts
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Contact: Ana Maria Gonzalez 437-929-5158 rbcd.clinicaltrials@uhn.ca

Sponsors and Collaborators
Kevin H.M. Kuo, MD, MSc, FRCPC
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Responsible Party: Kevin H.M. Kuo, MD, MSc, FRCPC, Principal investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05033314    
Other Study ID Numbers: 20-5846.0
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study data will be disclosed after successful conclusion of the definitive phase 3 study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Upper Extremity Deep Vein Thrombosis
Anemia, Sickle Cell
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Venous Thrombosis
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants