250 Participants Needed

Oral Blood Thinners for Hip Fracture

(HIP PRO Pilot Trial)

Recruiting at 2 trial locations
PS
JD
Overseen ByJessica Duong, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

As our Canadian population ages, hip fractures in these older adults are becoming very common. The best treatment for the majority of these injuries is urgent treatment with surgery. However, the hip fracture itself, the surgery required, and the immobility following these injuries are all risk factors for developing blood clots in the legs (deep vein thrombosis or DVT) and blood clots in the lungs (pulmonary embolism or PE). These complications are a common cause of death in patients with hip fractures and often result in prolonged medical treatment and hospital stays. Patients with hip fractures who require surgery are traditionally given injectable blood thinners to help prevent blood clots; however, these medications are costly, may not be tolerated well, and can be difficult to take, as prescribed. Oral blood thinning medications are being used more commonly, but it is unknown which of these medications is the most effective in preventing blood clots in patients after a hip fracture. Thrombelastography (TEG) technology uses a small sample of blood to evaluate a person's clotting ability. Our research has used TEG technology to evaluate blood clotting risk after hip fracture surgery and the investigators have found that platelets may play an important role in abnormal blood clotting after a hip fracture. The investigators have also shown that acetylsalicylic acid (ASA or Aspirin) may help reduce the abnormal platelet hyperactivity associated with blood clotting. This medication warrants investigation for blood clot prevention after hip fracture. The investigators propose to directly compare different oral medication regimens after hip fracture surgery, in order to determine which is safest and most effective in preventing blood clots. Our multi-disciplinary research team includes physicians, surgeons, and scientists with experience evaluating different medications for blood clot prevention. Our results will help determine the best medical treatment for preventing DVT and PE, which will benefit patients with hip fractures worldwide.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who have been on certain blood thinners like Warfarin, DOACs, or chronic aspirin use in the three months before the hip fracture. It's best to discuss your current medications with the trial team to see if they affect your eligibility.

What data supports the effectiveness of the drugs Acetylsalicylic acid (ASA) and Rivaroxaban for hip fracture?

Research shows that both aspirin (ASA) and rivaroxaban are effective in preventing blood clots after surgeries like knee and hip replacements, which are similar to hip fracture surgeries. They have been found to prevent conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE) without significantly increasing bleeding risks.12345

Is it safe to use oral blood thinners like aspirin and rivaroxaban for hip fracture?

Research shows that both aspirin and rivaroxaban are generally safe for use in preventing blood clots after surgeries like hip and knee replacements. They do not significantly increase the risk of major bleeding or other serious side effects.16789

How is the drug for hip fracture different from other treatments?

This treatment combines low-dose aspirin (acetylsalicylic acid, ASA) and rivaroxaban, both of which are anticoagulants (blood thinners) that help prevent blood clots. Unlike some other treatments, this combination is taken orally and is specifically studied for its effectiveness in preventing blood clots after hip fracture surgery, offering a potentially convenient and effective option.134610

Research Team

Prism Schneider, MD, PhD, FRCSC ...

Prism Schneider, MD

Principal Investigator

University of Calgary

Eligibility Criteria

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.

Inclusion Criteria

I am currently taking a single anti-platelet medication.
Signed informed consent or surrogate consent to participate in study
I am 50 or older and need surgery for a hip fracture that happened within the last day.
See 2 more

Exclusion 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 have a fracture around my hip replacement.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either rivaroxaban 10 mg daily or ASA 81 mg daily for 35 days post hip fracture surgery

5 weeks
Daily medication administration

Follow-up

Participants are monitored for safety and effectiveness, including VTE and bleeding complications, with assessments at various intervals

12 weeks
2-week, 4-week, 6-week, and 12-week follow-up visits

Long-term Follow-up

Participants are monitored for mortality and healthcare costs over a 12-month period

12 months

Treatment Details

Interventions

  • Acetylsalicylic acid (ASA) 81mg Oral Tablet
  • Rivaroxaban 10mg
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Findings from Research

In a study of 40 patients undergoing total knee arthroplasty, both aspirin (300 mg/day) and rivaroxaban (10 mg/day) were found to be equally effective in preventing venous thromboembolism (VTE), with no cases of deep vein thrombosis or pulmonary embolism reported.
Both medications were safe, showing no significant increase in wound complications or bleeding, indicating that either could be a suitable option for VTE prophylaxis after knee surgery.
Aspirin versus Rivaroxaban to Prevent Venous Thromboembolism after Total Knee Arthroplasty: A Double-blinded, Randomized Controlled Trial.Hongnaparak, T., Janejaturanon, J., Iamthanaporn, K., et al.[2022]
In a study of 479 patients undergoing hip or knee arthroplasty, rivaroxaban, used after enoxaparin for VTE prevention, showed zero cases of symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), death, stroke, or myocardial infarction during treatment, indicating high efficacy and safety.
The modified thromboprophylaxis regimen resulted in only one major bleeding episode (0.2%) and nine non-major bleeding episodes (1.9%), suggesting that this approach minimizes bleeding risks while effectively preventing VTE.
Efficacy and safety of rivaroxaban thromboprophylaxis after arthroplasty of the hip or knee: retrospective cohort study.Loganathan, V., Hua, A., Patel, S., et al.[2023]
In a study of 766 patients undergoing joint arthroplasty, no major bleeding events were associated with the use of rivaroxaban for thromboprophylaxis when combined with peripheral nerve blocks.
While some minor bleeding occurred, particularly at the surgical site after starting rivaroxaban, the overall data suggests that using nerve blocks in conjunction with rivaroxaban does not increase the risk of major bleeding.
Combination of Superficial and Deep Blocks with Rivaroxaban.Chelly, JE., Metais, B., Schilling, D., et al.[2015]

References

Aspirin versus Rivaroxaban to Prevent Venous Thromboembolism after Total Knee Arthroplasty: A Double-blinded, Randomized Controlled Trial. [2022]
Efficacy and safety of rivaroxaban thromboprophylaxis after arthroplasty of the hip or knee: retrospective cohort study. [2023]
Combination of Superficial and Deep Blocks with Rivaroxaban. [2015]
Comparison of the Efficacy and Safety of Aspirin and Rivaroxaban Following Enoxaparin Treatment for Prevention of Venous Thromboembolism after Hip Fracture Surgery. [2023]
Low-molecular-weight heparin versus rivaroxaban in orthopedic surgery. [2013]
Venous thromboembolism prophylaxis after total knee arthroplasty (TKA): aspirin vs. rivaroxaban. [2022]
Therapeutic potential of rivaroxaban in the prevention of venous thromboembolism following hip and knee replacement surgery: a review of clinical trial data. [2022]
Rivaroxaban, a new, oral, direct factor Xa inhibitor for thromboprophylaxis after major joint arthroplasty. [2019]
[Rivaroxaban (Xarelto): new anticoagulant inhibitor of factor Xa]. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
A systematic review on the effect of aspirin in the prevention of post-operative arterial thrombosis in patients undergoing total hip and total knee arthroplasty. [2018]