Back to resultsTHromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS) (THIS)
Primary Purpose
Sickle Cell Disease, Central Venous Catheter Thrombosis, Venous Thromboembolism
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Rivaroxaban 10 MG
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Sickle Cell Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Known allergy to study drug
- Strong indication for thromboprophylaxis at discretion of treating physician
- Significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data.
Sites / Locations
- University of Alberta HospitalRecruiting
- London Health Sciences CenterRecruiting
- Toronto General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rivaroxaban thromboprophylaxis
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The proportion of eligible patients who will enroll into a trial of thromboprophylaxis
Secondary Outcome Measures
Document indications for central venous catheter (CVC)
Summarize duration of CVC insertion prior to enrollment
Estimate adherence to the study drug
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
Defined as proportion of participant lost to follow up or withdrawn from the study prior to completion of 6 months of treatment
Full Information
NCT ID
NCT05033314
First Posted
August 5, 2021
Last Updated
September 30, 2023
Sponsor
Kevin H.M. Kuo, MD, MSc, FRCPC
1. Study Identification
Unique Protocol Identification Number
NCT05033314
Brief Title
THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)
Acronym
THIS
Official Title
THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS): A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kevin H.M. Kuo, MD, MSc, FRCPC
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Central Venous Catheter Thrombosis, Venous Thromboembolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rivaroxaban thromboprophylaxis
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 10 MG
Other Intervention Name(s)
Xarelto 10mg
Intervention Description
Rivaroxaban 10mg PO daily as thromboprophylaxis
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo daily
Primary Outcome Measure Information:
Title
The proportion of eligible patients who will enroll into a trial of thromboprophylaxis
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Document indications for central venous catheter (CVC)
Time Frame
1 year
Title
Summarize duration of CVC insertion prior to enrollment
Time Frame
1 year
Title
Estimate adherence to the study drug
Description
Adherence: percentage of administered drugs not returned (by pill counting);
Compliance: defined as percentage adherence >80%.
Time Frame
1 year
Title
Estimate participants compliance with study procedures, and lost to follow up
Description
Defined as proportion of participant lost to follow up or withdrawn from the study prior to completion of 6 months of treatment
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Venous thromboembolism (VTE)
Description
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.
Time Frame
1 year
Title
Major bleeding or clinically relevant non-major bleeding
Description
Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria
Time Frame
1 year
Title
Major bleeding
Description
Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria
Time Frame
1 year
Title
Clinically relevant non-major bleeding
Description
Defined as per International Society on Thrombosis and Haemostasis (ISTH) criteria
Time Frame
1 year
Title
Event-free survival
Description
Defined as free from VTE or major bleeding events
Time Frame
1 year
Title
Arterial thrombotic events
Description
Including myocardial infarction, ischemic stroke, and systemic embolism
Time Frame
1 year
Title
CVC change due to thrombosis or catheter occlusion not amenable to infusion of thrombolytics between study arms
Description
Proportion of participants requiring CVC change due to thrombosis or catheter occlusion not amenable to infusion of thrombolytics
Time Frame
1 year
Title
Quality of life using the modified Duke Anticoagulation Satisfaction Scale
Description
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"
Time Frame
1 year
Title
Bruising using a Likert scale
Description
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).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Known allergy to study drug
Strong indication for thromboprophylaxis at discretion of treating physician
Significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Briana Layard
Phone
437-929-5158
Email
rbcd.clinicaltrials@uhn.ca
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Sun, MD, MSc
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziad Solh, MD, MSc
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jameel Abdulrehman, MD, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study data will be disclosed after successful conclusion of the definitive phase 3 study
Learn more about this trial
THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)
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