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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00868179
Recruitment Status : Withdrawn (study never started)
First Posted : March 24, 2009
Last Update Posted : May 15, 2015
Ross K Leighton MD FRCSC
Information provided by:
Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Thromboembolism Drug: Pradax Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cohort (Follow Up) Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax (Tablet) Post Discharge for Ten Days, Without the Need for Routine Coagulation Monitoring and Dose Adjustment
Study Start Date : April 2009
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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
Drug: 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.
Other Name: Pradax dabigatran etexilate

Primary Outcome Measures :
  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 [ Time Frame: 28 day post op and 6 months radiograophically ]

Secondary Outcome Measures :
  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. [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00868179

Canada, Nova Scotia
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3h 1V7
Sponsors and Collaborators
Nova Scotia Health Authority
Ross K Leighton MD FRCSC
Principal Investigator: Ross K Leighton, MD FRCSC Nova Scotia Health Authority

Responsible Party: Ross K leighton MD, Capital District Health Authority Identifier: NCT00868179     History of Changes
Other Study ID Numbers: Pradax
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2009

Keywords provided by Nova Scotia Health Authority:
total knee replacement

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action