Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolis… (NCT00967447) | Clinical Trial Compass
TerminatedNot Applicable
Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* patients age 18 years or above undergoing elective total hip or knee replacement surgery
* Written informed consent obtained for data collection and source data verification.
Exclusion criteria:
According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:
* age of \> 75 years
* renal impairment (creatinine clearance \<50ml/min)
* patients on concomitant therapy with amiodarone or verapamil.
* elevated liver enzymes \>2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival
* anaesthesia with post-operative indwelling epidural catheters
* hypersensitivity to dabigatran etexilate or to any of the excipients
* active clinically significant bleeding
* organic lesion at risk of bleeding
* spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups
* concomitant treatment with quinidine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.