Contact information
Type
Scientific
Primary contact
Dr Michael Joseph Kovacs
ORCID ID
Contact details
Victoria Hospital
800 Commissioners Road East
Room A2-401
London
Ontario
N6A 4G5
Canada
+1 519 685 8475
michael.kovacs@lhsc.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00432796
Protocol/serial number
MCT-79607
Study information
Scientific title
A double blind randomised controlled trial of post-operative low molecular weight heparin bridging therapy versus placebo bridging therapy for patients who are at high risk for arterial thromboembolism
Acronym
PERIOP2
Study hypothesis
Efficacy:
Omitting post-operative bridging therapy with low molecular weight heparin (LMWH) will reduce the risk of thromboembolic complications in patients with prosthetic heart valves or atrial fibrillation who are at high risk for arterial embolism when warfarin is temporarily interrupted.
Safety:
Omitting post-operative bridging therapy with LMWH will reduce the risk of bleeding complications in patients with prosthetic heart valves or atrial fibrillation who are at high risk for arterial embolism when warfarin is temporarily interrupted.
Ethics approval
1. Research Ethics Board of the University of Western Ontario approved on the 12th September 2006 (ref: 12559)
2. Research Ethics Board of Ottawa Hospital, General Campus approved on the 20th October 2008 (ref: 2006513-01H)
3. Capital Health Research Ethics Board approved on the 27th September 2006 (ref: CDHA-RS/2006-247)
4. Hamilton Health Sciences Research Ethics Board approved on the 17th November 2006 (ref: 06-363)
5. McGill University Health Centre Research Ethics Board approved on the 2nd March 2007 (ref: 06-038)
6. SMBD-Jewish General Hospital Research Ethics Committee approved on the 4th October 2006 (ref: 06-078)
7. St. Paul's Hospital - Providence Health Care Research Institute approved on the 6th June 2007 (ref: H07-01391)
8. Toronto General Hospital - University Health Network Research Ethics Board approved on the 24th April 2008 (ref: 07-0788-A)
Study design
Multicentre, two arm, randomised parallel trial with study participant, study investigator, caregiver, and outcome assessor blinded
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Arterial thromboembolism
Intervention
Experimental:
1. Placebo 5,000 units subcutaneously once a day for four days post-operatively or until the International Normalised Ratio (INR) is greater than 2.0, or
2. Placebo 200 units subcutaneously once a day for four days post-operatively or until the INR is greater than 2.0
Control:
1. Dalteparin 5,000 units subcutaneously once a day for four days post-operatively or until the INR is greater than 2.0, or
2. Dalteparin 200 units subcutaneously once a day for four days post-operatively or until the INR is greater than 2.0
Intervention type
Drug
Phase
Not Applicable
Drug names
Dalteparin
Primary outcome measure
Major thromboembolism including:
1. Ischaemic stroke
2. Symptomatic myocardial infarction
3. Peripheral embolism
4. Valve thrombosis
5. Venous thromboembolism
6. Vascular death
Outcomes will be measured at three months.
Secondary outcome measures
1. Minor thromboembolism
2. Major bleeding
3. Minor bleeding
4. Overall survival
Outcomes will be measured at three months.
Overall trial start date
01/05/2006
Overall trial end date
01/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Informed consent
2. Patients of either sex, 18 years and older, with prosthetic heart valves receiving long-term oral anticoagulation with warfarin, or
3. Patients with atrial fibrillation and a major risk factor (previous transient ischaemic attack (TIA) or stroke, high blood pressure, diabetes, 75 years and older, moderate/severe left ventricle dysfunction), who require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1773
Participant exclusion criteria
1. Evidence of active bleeding prior to stopping warfarin
2. Platelet count less than 100 x 10^9/L
3. Spinal or neurosurgery
4. Life expectancy less than three months
5. Serum creatinine greater than 150 umol/L
6. Patients requiring cardiac surgery
7. Multiple prosthetic valves or Starr-Edwards valves or prosthetic valves with a history of stroke or TIA
Recruitment start date
01/05/2006
Recruitment end date
01/05/2011
Locations
Countries of recruitment
Canada
Trial participating centre
Victoria Hospital
London, Ontario
N6A 4G5
Canada
Sponsor information
Organisation
London Health Sciences Centre (Canada)
Sponsor details
370 South Street
Nurses Residence
Room C210
London
Ontario
N6A 4G5
Canada
+1 519 685 8500 ext. 75727
don.atkinson@lhsc.on.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79607)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer Canada Inc. (Canada) - medication only
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list