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29 August 2008
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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN26119679 |
| ClinicalTrials.gov identifier | NCT00432796 |
| Public 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 |
| Scientific title | |
| Acronym | PERIOP2 |
| Serial number at source | MCT-79607 |
| 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 |
Ethics approval received from:
1. Research Ethics Board of the University of Western Ontario on the 12th September 2006 (ref: 12559) 2. Research Ethics Board of Ottawa Hospital, General Campus, on the 20th October 2008 (ref: 2006513-01H) 3. Capital Health Research Ethics Board on the 27th September 2006 (ref: CDHA-RS/2006-247) 4. Hamilton Health Sciences Research Ethics Board on the 17th November 2006 (ref: 06-363) 5. McGill University Health Centre Research Ethics Board on the 2nd March 2007 (ref: 06-038) 6. SMBD-Jewish General Hospital Research Ethics Committee on the 4th October 2006 (ref: 06-078) 7. St. Paul's Hospital - Providence Health Care Research Institute on the 6th June 2007 (ref: H07-01391) 8. Toronto General Hospital - University Health Network Research Ethics Board 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 |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Arterial thromboembolism |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/05/2006 |
| Anticipated end date | 01/05/2011 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 1773 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
1. Minor thromboembolism
2. Major bleeding 3. Minor bleeding 4. Overall survival Outcomes will be measured at three months. |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79607)
2. Pfizer Canada Inc. (Canada) - medication only |
| Trial website | |
| Publications | |
| Contact name | Dr Michael Joseph Kovacs |
| Address |
Victoria Hospital
800 Commissioners Road East, Room A2-401 |
| City/town | London, Ontario |
| Zip/Postcode | N6A 4G5 |
| Country | Canada |
| Tel | +1 519 685 8475 |
| Fax | +1 519 685 8477 |
| michael.kovacs@lhsc.on.ca | |
| Sponsor | London Health Sciences Centre (Canada) |
| Address |
370 South Street
Nurses Residence, Room C210 |
| City/town | London, Ontario |
| Zip/Postcode | N6A 4G5 |
| Country | Canada |
| Tel | +1 519 685 8500 ext. 75727 |
| don.atkinson@lhsc.on.ca | |
| Sponsor website: | http://www.lhsc.on.ca/ |
| Date applied | 04/06/2008 |
| Last edited | 06/06/2008 |
| Date ISRCTN assigned | 04/06/2008 |
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