Sickle Cell DiseasePhase 3THISNCT05033314
THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)
A Phase 3 study testing Rivaroxaban 10 MG in people with Sickle Cell Disease and Central Venous Catheter Thrombosis, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Central Venous Catheter Thrombosis, Venous Thromboembolism
- What is being tested?
- Rivaroxaban 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 3 sitesCanada
- Study dates
- 7 Jun 2022to 1 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
London Health Sciences Center
London, Ontario, N6A 5W9
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS): A Pilot Study
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?
Read more
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.
- Being tested
- Rivaroxaban 10 MG, Placebo
- Medical subject headings
- Anemia, Sickle Cell, Upper Extremity Deep Vein Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MGDrug
Also called Xarelto 10mg
Rivaroxaban 10mg PO daily as thromboprophylaxis
PlaceboDrug
matching placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban thromboprophylaxis | Experimental | Not described Receives: Drug: Rivaroxaban 10 MG |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of eligible patients who will enroll into a trial of thromboprophylaxis
Measured: 1 year
Secondary outcomes (4)
Document indications for central venous catheter (CVC)
Measured: 1 year
Summarize duration of CVC insertion prior to enrollment
Measured: 1 year
Estimate adherence to the study drug
- Adherence: percentage of administered drugs not returned (by pill counting);
- Compliance: defined as percentage adherence >80%.
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start7 Jun 2022
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Study terminated due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033314
- Sponsor's protocol ID
- 20-5846.0
- Acronym
- THIS
- Status last verified
- Oct 2024
- First submitted
- 5 Aug 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will be disclosed after successful conclusion of the definitive phase 3 study
Publications
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.
PubMed 41249873Abdulrehman 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.
PubMed 38171625
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS): A Pilot Study
- ClinicalTrials.gov ID
- NCT05033314
- Acronym / sponsor ID
- THIS / 20-5846.0
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to slow recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban thromboprophylaxis | Experimental | Drug: Rivaroxaban 10 MG |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 10 MGAlso: Xarelto 10mgRivaroxaban 10mg PO daily as thromboprophylaxis | Drug | Rivaroxaban thromboprophylaxis |
| Placebomatching placebo daily | Drug | Placebo |
Primary outcome
The proportion of eligible patients who will enroll into a trial of thromboprophylaxis
Time frame: 1 year
4 secondary outcomes
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
Estimate participants compliance with study procedures, and lost to follow up
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study terminated due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 41249873Abdulrehman 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.
- Derived from this study: PubMed 38171625Abdulrehman 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.
- Individual participant dataSharing planned: No. Study data will be disclosed after successful conclusion of the definitive phase 3 study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban 10 MG in people with Sickle Cell Disease and Central Venous Catheter Thrombosis, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to slow recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of eligible patients who will enroll into a trial of thromboprophylaxis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05033314, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.