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

Not provided at time of registration

Contact information

Dr Michael Joseph Kovacs
Scientific

Victoria Hospital
800 Commissioners Road East, Room A2-401
London, Ontario
N6A 4G5
Canada

Phone	+1 519 685 8475
Email	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 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(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)
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
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
Overall study end date	01/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1773
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 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

Study participating centre

Victoria Hospital

London, Ontario
N6A 4G5
Canada

Sponsor information

London Health Sciences Centre (Canada)
Research organisation

370 South Street
Nurses Residence, Room C210
London, Ontario
N6A 4G5
Canada

Phone	+1 519 685 8500 ext. 75727
Email	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.