Back to resultsA Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days
Primary Purpose
Thromboembolism
Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pradax
Sponsored by
About this trial
This is an interventional treatment trial for Thromboembolism focused on measuring Thrombosis, total knee replacement
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.
Sites / Locations
- Halifax Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pradax
Arm Description
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
Outcomes
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
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.
Full Information
NCT ID
NCT00868179
First Posted
March 23, 2009
Last Updated
November 8, 2022
Sponsor
Ross Leighton
Collaborators
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT00868179
Brief Title
A Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days
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 Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
study never started
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ross Leighton
Collaborators
Nova Scotia Health Authority
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism
Keywords
Thrombosis, total knee replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pradax
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Pradax
Other Intervention Name(s)
Pradax dabigatran etexilate
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross K Leighton, MD FRCSC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3h 1V7
Country
Canada
12. IPD Sharing Statement
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A Cohort Study With 100 Subjects Having a Primary Total Knee Replacement, Taking Pradax Post Discharge for Ten Days
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