Study on Shortened Anticoagulation with Rivaroxaban for Blood Clot Prevention in Patients Undergoing Hip Replacement Surgery

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What is this study about?

This clinical trial is focused on patients who are undergoing a planned hip replacement surgery, known as hip arthroplasty. The study is examining the use of a medication called Rivaroxaban, which is a type of blood thinner, to prevent blood clots after surgery. Blood clots can lead to serious conditions like deep vein thrombosis (DVT) or pulmonary embolism (PE). The trial will compare a shorter treatment period of 10 days with the usual 35-day treatment to see if the shorter period is just as effective in preventing these complications.

Participants in the study will receive either the medication Rivaroxaban or a placebo, which looks like the medication but does not contain the active ingredient. The study aims to find out if the shorter duration of taking Rivaroxaban is as safe and effective as the longer duration. The trial will monitor for any signs of blood clots, as well as other health outcomes such as overall recovery, any serious side effects, and the need for additional hospital visits.

The study will follow participants for up to 90 days after they join to track their recovery and any health issues that arise. This research is important to potentially reduce the length of time patients need to take blood thinners after hip surgery, which could lead to fewer side effects and a quicker return to normal activities.

1 joining the study

Participation begins after providing written informed consent.

Eligibility includes being between 18 and 85 years old, scheduled for a primary hip replacement, and meeting specific health criteria.

2 surgery preparation

Preparation follows the Enhanced Recovery after Surgery (ERAS) protocol, which is a plan to help recover quickly after surgery.

A baseline mobility test, called the Timed Up and Go (TUG) test, is conducted to assess mobility before surgery.

3 surgery and initial recovery

Undergo elective unilateral primary hip arthroplasty, which is a planned hip replacement surgery.

Initial recovery involves following the ERAS protocol to enhance recovery.

4 medication administration

Receive a direct oral anticoagulant (DOAC) called Rivaroxaban in the form of hard gelatin capsules.

The medication is taken orally for 10 days to prevent blood clots, which is shorter than the standard 35-day duration.

5 monitoring and follow-up

Monitoring for any symptoms of venous thromboembolism (VTE), which includes blood clots in the veins or lungs, for 90 days after joining the study.

Regular assessments of mobility, quality of life, and any adverse events.

6 completion of study participation

Participation concludes after the 90-day monitoring period.

Final assessments include checking for any health changes and overall recovery status.

Who Can Join the Study?

  • Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
  • Be between the ages of 18 and 85 years.
  • Be scheduled to have a planned surgery called elective unilateral primary THA (total hip arthroplasty) and be eligible for a special recovery plan called the ERAS protocol (Enhanced Recovery after Surgery).
  • Have a Timed Up and Go (TUG) test score of less than 20 seconds, which shows you have good mobility before the surgery. This test measures how quickly you can stand up from a chair, walk a short distance, and sit down again.
  • Be able to understand and follow the study requirements, such as having enough knowledge of the German language to answer questions and being able to swallow capsules whole.
  • If you are a woman, have a negative serum pregnancy test and use a highly effective method of birth control during the study treatment.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
GPR Gesundheits und Pflegezentrum Ruesselsheim gGmbH Ruesselsheim Am Main Germany
University Of Luebeck Luebeck Germany
BG Klinikum Hamburg gGmbH Hamburg Germany
Epzydikqoslml Wpvxatiiomvaobz Sachpmm Kkulnjsrionbkafzxtu gtlse Berlin Germany
Eerceuxfykqaxxzi Bcutot Bguwrnpqyyi Berlin Germany
Jcnwwxqa Kntiil Uoiaawbkcm Linz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.06.2024
Germany Germany
Recruiting
30.06.2024

Trial locations

Investigated drugs:

Direct Oral Anticoagulant (DOAC) is a type of medication used to prevent blood clots. In this trial, it is being tested to see if a shorter duration of use after hip surgery is as effective as the longer, standard duration. The goal is to prevent conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE), which are types of blood clots that can occur after surgery.

Investigated diseases:

Venous Thromboembolism (VTE) – This condition involves the formation of blood clots in the veins, which can lead to serious complications. It primarily includes two types: deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT occurs when a blood clot forms in a deep vein, usually in the legs, causing pain and swelling. If a part of the clot breaks off, it can travel to the lungs and cause a PE, which can lead to difficulty breathing and chest pain. VTE can develop after surgery, especially in patients with limited mobility. Preventive measures are often taken to reduce the risk of clot formation.

Trial ID:
2023-507490-18-00
Protocol code:
23-01496
NCT ID:
NCT06611319
Trial Phase:
Therapeutic confirmatory (Phase III)

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