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

NCT00868179 | Withdrawn Phase 4 DMC

• 1 other identifier: Pradax
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolism

Keywords

Thrombosis; total knee replacement

Outcome Measures

Primary Outcomes (1)

• The primary efficacy outcome will be the clinical evidence of any deep vein thrombosis, non-fatal pulmonary embolism or death from any causes within 28 days after surgery. The primary safety outcome is major bleeding

  28 day post op and 6 months radiograophically

Secondary Outcomes (1)

• Secondary efficacy end points will be the radiographic assessment of healing, the clinical assessment of weight-¬bearing status at 6 months post treatment, and the incidence of additional surgical/medical interventions to promote healing.

  6 Months

Study Arms (1)

Pradax

EXPERIMENTAL

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

Drug: Pradax

Interventions

Pradax 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.

Also known as: Pradax dabigatran etexilate

Pradax

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ross Leighton: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Halifax Infirmary

Halifax, Nova Scotia, B3h 1V7, Canada

Location

MeSH Terms

Conditions

Thromboembolism; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ross K Leighton, MD FRCSC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CA (1)