A Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days

NCT ID: NCT00868179

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-04-30

Brief Summary

Currently standard of care for preventing blood clots in total knee replacement patients is the drug Fragmin which is a daily injection for 10 days after surgery. Patients are in hospital for 3 to 5 days after total knee replacement surgery and patients are taught in hospital to do their injections.

The investigators would like to introduce the drug Pradax. Pradax is a Health Canada approved once a day, oral drug that may prevent blood clots in the patient's leg. In this study the patient will receive the standard of care injection drug Fragmin while in hospital but on discharge home the patient will take the oral drug Pradax daily (2 tablets 110mg) for 10 days.

Detailed Description

We will enroll one hundred patients who are scheduled to have a total knee replacement. If you have signed the consent form for this study you will receive the standard of care treatment for blood clots, which is a daily injection drug called Fragmin. On the day of discharge from hospital study patients will receive a ten day supply of oral Pradax. to be taken once a day. The Orthopaedic research coordinator will call the study patients at post discharge day three and five to check on compliance and or concerns. All total knee replacement patients whether in study or not are seen in the Orthopaedic clinic at post op day 10 for staple removal and again at the 6 week point, 3 month, and 6 month and 1 year point. Standard of care x-rays are done also at these visits.

Conditions

Thromboembolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pradax

This is the only arm in the study and all will follow the same protocol for the study which is taking the pradax after total knee replacement

Group Type: EXPERIMENTAL

Pradax

Intervention Type: DRUG

Pradax (dabigatran etexilate) is a prodrug that when converted to the active from in the liver and plasma it becomes a reversible, competitive direct thrombin inhibitor. Thrombin catalyses the conversion of soluble fibrinogen into soluble fibrin, the final step in the coagulation cascade. Pradax competitively blocks the active site of both free and clot-bound thrombin, preventing the development of a thrombus. they will take 110 mg 1-4 hours post op. and 220mg daily until 10 days post op.

Interventions

Pradax

Pradax (dabigatran etexilate) is a prodrug that when converted to the active from in the liver and plasma it becomes a reversible, competitive direct thrombin inhibitor. Thrombin catalyses the conversion of soluble fibrinogen into soluble fibrin, the final step in the coagulation cascade. Pradax competitively blocks the active site of both free and clot-bound thrombin, preventing the development of a thrombus. they will take 110 mg 1-4 hours post op. and 220mg daily until 10 days post op.

Intervention Type: DRUG

Other Intervention Names

Pradax dabigatran etexilate

Eligibility Criteria

Inclusion Criteria

• Patients are eligible for the study if they are adult age, being greater than 18 years of age and less than 95 years of age. They must have the indications for a total knee replacement and have sufficiently passed the medically necessary tests by their surgeon to warrant total knee replacement.

Exclusion Criteria

• Patients with active bleeding, or high risk of bleeding that contra-indicates the use of Pradax
• Renal or liver contra-indication necessitating adjustments of its dose.
• Clinically significant liver disease,
• Concomitant use of Proteus Ace inhibitors
• The use of the human immunitive deficiency virus
• The use of fibrinolynic agents
• Planned intermittent pneumatic compression or requirement of ongoing anticoagulation therapy
• Pregnancy
• Breast-feeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

Ross Leighton

OTHER

Sponsor Role: lead

Responsible Party

Ross Leighton

Orthopedic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ross K Leighton, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

Halifax Infirmary

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

Pradax

Identifier Type: -

Identifier Source: org_study_id