Post-operative low molecular weight heparin bridging therapy versus placebo bridging therapy for patients who are at high risk for arterial thromboembolism
| ISRCTN | ISRCTN26119679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26119679 |
| ClinicalTrials.gov number | NCT00432796 |
| Secondary identifying numbers | MCT-79607 |
- Submission date
- 04/06/2008
- Registration date
- 04/06/2008
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Joseph Kovacs
Scientific
Scientific
Victoria Hospital
800 Commissioners Road East, Room A2-401
London, Ontario
N6A 4G5
Canada
| Phone | +1 519 685 8475 |
|---|---|
| michael.kovacs@lhsc.on.ca |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study acronym | PERIOP2 |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2006 |
| Completion date | 01/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1773 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/05/2011 |
Locations
Countries of recruitment
- Canada
Study participating centre
Victoria Hospital
London, Ontario
N6A 4G5
Canada
N6A 4G5
Canada
Sponsor information
London Health Sciences Centre (Canada)
Research organisation
Research organisation
370 South Street
Nurses Residence, Room C210
London, Ontario
N6A 4G5
Canada
| Phone | +1 519 685 8500 ext. 75727 |
|---|---|
| don.atkinson@lhsc.on.ca | |
| Website | http://www.lhsc.on.ca/ |
"ROR" |
https://ror.org/037tz0e16 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79607)
No information available
Pfizer Canada Inc. (Canada) - medication only
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/11/2018 | 19/02/2019 | Yes | No |
Editorial Notes
11/04/2019: Internal review.
19/02/2019: Conference proceedings added.
