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Rivaroxaban for Preventing Blood Clots in Sickle Cell Disease (THIS Trial)

Phase 3

Recruiting

Research Sponsored by Kevin H.M. Kuo, MD, MSc, FRCPC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New or pre-existing CVC planned for long term use (at least 6 months)

Adult (age 18 or older)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

THIS Trial Summary

This trial will assess the safety & feasibility of using rivaroxaban to prevent blood clots in adults with sickle cell disease who have a central venous catheter.

Who is the study for?

Adults over 18 with Sickle Cell Disease (SCD) who have or will get a Central Venous Catheter (CVC) intended for long-term use can join. They must be able to consent and not have conditions like recent blood clots, severe kidney issues, low platelets, extreme weight loss, uncontrolled high blood pressure, certain drug interactions, allergies to the study medication, or other serious health risks.Check my eligibility

What is being tested?

The trial is testing if Rivaroxaban can prevent blood clots in adults with SCD who have CVCs. It's a pilot study where participants are randomly given either Rivaroxaban or a placebo daily for up to one year while their CVC is in place. The trial tracks enrollment rates and adherence to the medication regimen.See study design

What are the potential side effects?

Potential side effects of Rivaroxaban may include bleeding complications since it's designed to prevent clotting. Other side effects could vary based on individual reactions but aren't specified here.

THIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have or will get a long-term central venous catheter.

Select...

I am 18 years old or older.

THIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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)

Estimate adherence to the study drug

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

+1 more

Other outcome measures

Arterial thrombotic events

Bruising using a Likert scale

CVC change due to thrombosis or catheter occlusion not amenable to infusion of thrombolytics between study arms

+6 more

THIS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Rivaroxaban thromboprophylaxisExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rivaroxaban

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kevin H.M. Kuo, MD, MSc, FRCPCLead Sponsor

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other studies have been conducted concerning the efficacy of Rivaroxaban as a form of thromboprophylaxis?

"The Montreal Heart Institute first initiated research into rivaroxaban thromboprophylaxis in 2015. Since then, 19703 trials have been completed and another 44 are live experiments predominantly being conducted at London, Ontario."

Answered by AI

Has the FDA approved Rivaroxaban for thromboprophylaxis?

"The safety of Rivaroxaban thromboprophylaxis was evaluated as a 3 due to empirical evidence concerning its efficacy, and multiple studies confirming it is safe."

Answered by AI

What purpose does Rivaroxaban thromboprophylaxis typically serve?

"Rivaroxaban can provide thromboprophylaxis for deep vein thrombosis (DVT), chronic coronary artery disease, and other similar conditions."

Answered by AI

Is enrollment into this research endeavor still available for participants?

"Per the clinicaltrials.gov platform, this medical trial is actively seeking volunteers to participate in its experiment. The study was first made available on June 7th 2022 and the latest update was posted on September 30th 2023."

Answered by AI

How many volunteers are involved in the evaluation of this experiment?

"Confirmed, clinicaltrials.gov reveals that this medical trial is still accepting participants. It was originally listed on June 7th 2022 and was recently modified on September 30th 2023; 50 individuals are needed from 3 different sites for the experiment to be completed."

Answered by AI

Does this trial mark a groundbreaking precedent in the field of medicine?

"Since 2015, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma has funded a series of studies into Rivaroxaban thromboprophylaxis. Initially, the research involved 1424 participants and culminated in phase 3 approval for the drug. Currently there are 44 active trials with locations spanning 27 countries and 266 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kevin H.M. Kuo, MD, MSc, FRCPC 2022. "THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05033314.

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