Overview
Venous Thromboembolism Research Study Overview
This study aims to investigate a potential treatment for venous thromboembolism in adults undergoing total knee replacement surgery. If you are currently planning to undergo total knee replacement surgery, please know that you are not alone in your medical journey. Knee replacement surgery is a common operation that helps people manage long-term pain and limited mobility. Every year, hundreds of thousands of people worldwide choose this surgery to get back to walking comfortably, climbing stairs, and enjoying daily activities.
As with all surgeries, recovery can come with risks. One of the main risks after knee replacement is the development of blood clots, called venous thromboembolism (VTE). A VTE is a blood clot (thrombus) that has formed in a vein. It can move anywhere in the body and block the blood flow. A piece of the clot may break loose; this is called an embolus. The embolus can travel to your lungs and cause a life-threatening clot called a pulmonary embolism (PE).
Reducing or preventing the formation of blood clots can decrease the chances of developing serious conditions such as heart attacks and strokes. Currently, we are working on developing potential treatments to help prevent venous thromboembolism.
What is Venous Thromboembolism?
A venous thromboembolism (VTE) is a blood clot (thrombus) that has formed in a vein. It can move anywhere in the body and block the blood flow. A piece of the clot may break loose; this is called an embolus. The embolus can travel to your lungs and cause a life-threatening clot called a pulmonary embolism (PE). Reducing or preventing the formation of blood clots can decrease the chances of developing serious conditions.
Table of Contents
About the Study
This Venous Thromboembolism research study is investigating the safety and effects of the potential medicine in a large group of people. The purpose of this study is to see how effective the study treatment is at preventing venous thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to another treatment.
The study treatment is an antibody that targets Factor XI, a protein in your blood that is involved in the formation of blood clots. This study is double-blinded, which means that you and the study doctor or the staff will not know which treatment you are receiving. You will be randomly assigned to one of two treatment groups, similar to flipping a coin:
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Group 1: A single intravenous (IV) infusion of the study treatment within 3 hours after your surgery and placebo tablets twice a day for 30 days.
Group 2: A single intravenous (IV) infusion of a placebo within 3 hours after your surgery and the comparator treatment (acetylsalicylic acid) in the form of tablets twice a day for 30 days.
Benefits
By participating in the Venous Thromboembolism research study, you may play a key role in helping us learn more about VTE and other diseases that can occur after a total knee replacement surgery. This contribution may benefit others in the future who face this condition. Every treatment that exists today is available because of study participants who actively took part in research.
Participants in this study will receive medical care related to their participation, including the study treatment and study-related tests, at no cost. You will also receive a full medical check-up to see if you qualify, which may involve several tests.
Who Can Join
To determine if you are eligible for the Venous Thromboembolism research study, the study team will review your medical history and perform specific assessments.
Inclusion Criteria:
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18 years old or older
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Undergoing an elective primary unilateral total knee replacement surgery.
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Able and willing to provide signed informed consent.
Exclusion Criteria:
- Known personal or family history of a congenital bleeding disorder.
- Active bleeding or high risk of bleeding that would contraindicate the use of anticoagulant prophylaxis.
- Use of certain prohibited medications, such as chronic anticoagulants.
- History of major surgery or trauma within 3 months prior to the planned surgery.
- Known allergy or hypersensitivity to any of the study treatments or their components.
Not sure if you qualify?
A member of our study team will review your medical history and medications with you to determine if this venous thromboembolism research study may be a good fit for you. You may also qualify for other studies.
What to Expect
Participation in the Venous Thromboembolism research study is 100% voluntary, and you may leave the study at any time without it affecting your regular health care.
Study Duration and Visits:
- Total Duration: Your participation may last up to approximately 120 days.
- Screening Period: Up to 30 days before your surgery, involving 1 visit for initial tests and procedures.
- Treatment Period: From the day of surgery through day 30, involving about 3 study visits.
- Follow-up Period: A final follow-up or end-of-study visit will occur about 90 days after your surgery.
Study Procedures:
If you join the study, you will be expected to attend study visits and undergo certain assessments. These include blood draws, physical exams, vital signs, and electrocardiograms (ECGs). You will receive a single IV infusion within 3 hours after your surgery and will take tablets twice daily for 30 days.
Compensation:
Qualified participants may be reimbursed for travel to and from study visits. You may also receive payment as compensation for your time and participation in the research study. The specific amount of compensation will be discussed with you by the study team during the consent process.
Need More Details?
The study team will explain all procedures, site visits, and other requirements in detail before you decide to participate in the venous thromboembolism research study.
