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

This study has been withdrawn prior to enrollment.
(study never started)
Sponsor:
Collaborator:
Ross K Leighton MD FRCSC
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00868179
First received: March 23, 2009
Last updated: July 27, 2011
Last verified: May 2009
  Purpose

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 Intervention Phase
Thromboembolism
Drug: Pradax
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868179

Locations
Canada, Nova Scotia
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3h 1V7
Sponsors and Collaborators
Capital District Health Authority, Canada
Ross K Leighton MD FRCSC
Investigators
Principal Investigator: Ross K Leighton, MD FRCSC Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Ross K leighton MD, Capital District Health Authority
ClinicalTrials.gov Identifier: NCT00868179     History of Changes
Other Study ID Numbers: Pradax
Study First Received: March 23, 2009
Last Updated: July 27, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Capital District Health Authority, Canada:
Thrombosis
total knee replacement

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014