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Antiplatelet Agent
Oral Blood Thinners for Hip Fracture (HIP PRO Pilot Trial)
Phase 3
Waitlist Available
Led By Prism S Schneider, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Summary
This trial will compare different oral blood thinning medications to find the safest + most effective treatment to prevent blood clots after hip fracture surgery. It will benefit patients with hip fractures worldwide.
Who is the study for?
This trial is for adults aged 50 or older who have a hip fracture that needs surgery and got to the hospital within 24 hours of injury. They can be on low-dose anti-platelet therapy like aspirin. People with cancer-related fractures, those who can't follow up, took lots of blood thinners post-injury, or have certain bleeding/clotting disorders can't join.Check my eligibility
What is being tested?
The study compares oral blood thinners Rivaroxaban (10mg) and ASA (81mg) in preventing blood clots after hip fracture surgery. It aims to find out which one is safer and more effective using TEG technology to monitor clotting ability.See study design
What are the potential side effects?
Possible side effects include bleeding risks, allergic reactions to the medications, potential gastrointestinal issues with ASA use such as ulcers, and kidney problems if there's pre-existing renal failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment Rate
Secondary outcome measures
Arterial thromboembolism events
Bleeding complications
Complete Blood Counts
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: acetylsalicylic acid (ASA) 81mg dailyExperimental Treatment1 Intervention
acetylsalicylic acid (ASA) 81mg daily for 35 days post hip fracture surgery
Group II: Rivaroxaban 10mgExperimental Treatment1 Intervention
Rivaroxaban 10mg daily for 35 days post hip fracture surgery
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
800 Previous Clinical Trials
874,920 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,354 Previous Clinical Trials
26,460,269 Total Patients Enrolled
Prism S Schneider, MD, PhDPrincipal InvestigatorUniversity of Calgary
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 50 years old.I have been on blood thinners like Warfarin or aspirin for the last three months before my hip fracture.I am currently taking a single anti-platelet medication.I have a fracture around my hip replacement.I needed multiple brain scans or surgery due to bleeding in my brain.I am allergic to rivaroxaban or have severe kidney problems.I am 50 or older and need surgery for a hip fracture that happened within the last day.I have fractures due to cancer spreading to my bones.My fracture is either open or closed and will be recorded.I need extended or delayed blood clot prevention due to multiple injuries.I have a genetic condition that affects my blood's ability to clot.I have taken more than two doses of a blood clot prevention medication after surgery.I cannot attend follow-up visits.
Research Study Groups:
This trial has the following groups:- Group 1: Rivaroxaban 10mg
- Group 2: acetylsalicylic acid (ASA) 81mg daily
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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