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Trial NCT00432796

Resource URI: http://static.linkedct.org/resource/trials/NCT00432796
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/19439>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/7632>
linkedct:brief_title PERIOP 2 - A Safety and Effectiveness Study of LMWH Bridging Therapy Versus Placebo Bridging Therapy for Patients on Long Term Warfarin and Require Temporary Interruption of Their Warfarin.
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/6280>
linkedct:condition <http://static.linkedct.org/resource/condition/12595>
linkedct:criteria Inclusion Criteria: 1. Informed consent, 2. Patients aged >18 with prosthetic heart valves receiving long-term oral anticoagulation with warfarin, or 3. Patients with atrial fibrillation and a major risk factor (previous TIA or stroke, high blood pressure, diabetes, aged >75, moderate/severe left ventricle dysfunction), who require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy. Exclusion Criteria: 1. Evidence of active bleeding within last 30 days prior to stopping warfarin. 2. Platelet count <100 x 109/L. 3. Spinal or neurosurgery. 4. Life expectancy less than 3 months. 5. Calculated creatinine clearance <30 ml/min 6. Patients requiring cardiac surgery. 7. Multiple prosthetic valves or Starr-Edwards valves or prosthetic valves with a history of stroke or TIA 8. History of heparin induced thrombocytopenia (HIT)
linkedct:description There are a growing number of patients who receive long-term warfarin therapy for the prevention of arterial thromboembolism. The current approach to the perioperative management of anticoagulation (i.e. "bridging therapy") with low molecular weight heparin (LMWH) is not standardized and has not been assessed by adequate randomized studies. Most clinicians, however, recommend bridging therapy. We have recently completed a multicentre single arm pilot study of LMWH bridging therapy. This study in 10 centres accrued 224 patients in 10 months. In the pilot study the postoperative thromboembolic event rate was 3.1% and 75% of these occurred in patients who had anticoagulation held due to bleeding. Design:A prospective multicentre randomized double-blind controlled trial. Patients: Consecutive eligible and consenting patients from 11 teaching hospitals in Canada. A total of 1773 patients with prosthetic heart valves receiving long-term oral anticoagulation with warfarin or patients with atrial fibrillation and a major risk factor who require elective non-cardiac surgery or invasive procedure necessitating reversal of their oral anticoagulant therapy. Treatment Schedule: Consent will be obtained preoperatively but randomization will be performed postoperatively after confirming eligibility. Preoperative period: In all participants, warfarin therapy will be discontinued five days prior to the procedure. Dalteparin, a LMWH, will be administered at 200 IU/kg sc early in the morning for the three days prior to, but not including the day of, the procedure except on the day prior to surgery the dose will be 100 I.U./kg given 24 hours preoperatively. Warfarin will be resumed the evening of the procedure. Postoperative period: Dalteparin or placebo will be administered daily (starting the morning after the procedure), provided surgical hemostasis is achieved, and will be continued for at least four days and until the INR is>2.0. Patients considered at high risk for a postoperative major bleed will be given dalteparin or placebo at a dose of 5,000 IU sc daily. Patients who undergo procedures that are considered low risk for bleeding complications will resume dalteparin or placebo at 200 IU/Kg s.c. daily. Outcomes:The primary outcome will be the frequency of episodes of major thromboembolism over a 90-day follow-up period following the time of randomization. Secondary outcomes will include major bleeding and overall survival. Relevance: To bridge or not to bridge, is a common clinical question, without randomized trial evidence to guide clinicians. This RCT will answer whether post-operative bridging reduces risk of thromboembolism or causes harm.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date March 2013
linkedct:enrollment 1773 (xsd:int)
linkedct:firstreceived_date February 7, 2007
linkedct:has_dmc Yes
linkedct:id NCT00432796
linkedct:intervention <http://static.linkedct.org/resource/intervention/105647>
linkedct:intervention <http://static.linkedct.org/resource/intervention/78675>
rdfs:label Trial NCT00432796
linkedct:lastchanged_date December 8, 2008
linkedct:lead_sponsor_agency Lawson Health Research Institute
linkedct:location <http://static.linkedct.org/resource/location/16535>
linkedct:location <http://static.linkedct.org/resource/location/17850>
linkedct:location <http://static.linkedct.org/resource/location/17967>
linkedct:location <http://static.linkedct.org/resource/location/18669>
linkedct:location <http://static.linkedct.org/resource/location/19634>
linkedct:location <http://static.linkedct.org/resource/location/19754>
linkedct:location <http://static.linkedct.org/resource/location/19885>
linkedct:location <http://static.linkedct.org/resource/location/23233>
linkedct:nct_id NCT00432796
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Double Blind Randomized Control Trial of Post-Operative Low Molecular Weight Heparin Bridging Therapy Versus Placebo Bridging Therapy for Patients Who Are at High Risk for Arterial Thromboembolism (PERIOP 2)
linkedct:org_study_id R-06-267
linkedct:overall_contact_email melinda.robbins@lhsc.on.ca
linkedct:overall_contact_last_name Melinda Robbins, R.P.N
linkedct:overall_contact_phone 519-685-8500
linkedct:overall_contact_phone_ext 55400
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/40811>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00432796>
linkedct:phase Phase 3
linkedct:primary_completion_date March 2013
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/51732>
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linkedct:secondary_id NRA6300019
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linkedct:source Lawson Health Research Institute
linkedct:start_date December 2006
linkedct:study_design Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of the study is to determine the effectiveness and safety of LMWH postoperative bridging therapy (standard of care) versus postoperative placebo bridging therapy (experimental arm)for patients with mechanical heart valves or atrial fibrillation who are at high risk for stroke when warfarin is temporarily interrupted for a procedure.
rdf:type linkedct:trials
linkedct:verification_date December 2008