Extended Prophylaxis Comparing low molecular weight heparin (LMWH) to Aspirin in Total hip arthroplasty

ISRCTN	ISRCTN11902170
DOI	https://doi.org/10.1186/ISRCTN11902170
Protocol serial number	MCT-82948
Sponsor	Dalhousie University (Canada) - Research Services
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-82948), Bayer Healthcare (Canada), Pfizer (Canada) - added 05/12/2007

Submission date: 27/09/2007
Registration date: 27/09/2007
Last edited: 05/08/2013

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 David Robert Anderson
Scientific

Queen Elizabeth II (QEII) Health Sciences Centre and Dalhousie University
Room 430 Bethune Building, 4th floor
1278 Tower Road
Halifax, Nova Scotia
B3H 2Y9
Canada

Phone	+1 902 473 8562
Email	David.Anderson@cdha.nshealth.ca

Study information

Primary study design	Interventional
Study design	Multicentre, two arm, randomised parallel trial, using placebo, with study participant, research coordinator, study investigator, caregiver, outcome assessor, and data analyst blinded
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EPCAT
Study objectives	Current hypothesis as of 05/12/2007: Extending the duration of anti-thrombotic prophylaxis with aspirin by 28 days following a ten day course of Low Molecular Weight Heparin (LMWH) will be as effective at reducing the rate of symptomatic venous thromboembolic complications and will be safe and more cost-effective than extending prophylaxis by 28 days with LMWH in a group of patients undergoing total hip arthroplasty. Previous hypothesis: Extending the duration of anti-thrombotic prophylaxis with aspirin by 28 days following a minimum seven day course of Low Molecular Weight Heparin (LMWH) will be as effective at reducing the rate of symptomatic venous thromboembolic complications and will be safe and more cost-effective than extending prophylaxis by 28 days with LMWH in a group of patients undergoing total hip arthroplasty. Please note that this record has been updated on the 5th December 2007 due to changes made to this protocol by the suggestion of the Research Ethics Board (REB). All changes were made prior to the recruitment of the first study participant and will be entered in this record under the date 05/12/2007.
Ethics approval(s)	Research Ethics Board of Capital District Health Authority, Halifax, Nova Scotia, Canada approved on the 17th September 2007 (ref: CDHA-RS/2007-179)
Health condition(s) or problem(s) studied	Venous thromboembolism following total hip arthoplasty
Intervention	Current interventions as of 05/12/2007: 1. Aspirin: 81 mg once a day for 28 days 2. Dalteparin: 5000 i.u. subcutaneously once a day 3. Matching placebo (aspirin): one pill once a day for 28 days 4. Matching placebo (dalteparin-normal saline): injection subcutaneously once a day for 28 days Previous interventions: 1. Aspirin: 81 mg once a day for 28 days 2. Enoxaparin: 40 mg subcutaneously once a day for 28 days 3. Matching placebo (aspirin): one pill once a day for 28 days 4. Matching placebo (enoxaparin): injection subcutaneously once a day for 28 days Contact for public queries: Susan Pleasance, Associate Director Haematology Research Centre for Clinical Research 5790 University Avenue, Room 132 Halifax, Nova Scotia B3H 1V7 Canada Tel: +1 902 473 7585 Fax: +1 902 473 4667 Email: Susan.Pleasance@cdha.nshealth.ca
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Aspirin, dalteparin
Primary outcome measure(s)	Current primary outcome measures as of 15/01/2008: Venous thromboembolism (pulmonary embolism of deep vein thrombosis), assessed at 90 days. Previous primary outcome measures: 1. Symptomatic venous thromboembolic complications, assessed at 90 days 2. Venous thromboembolism (pulmonary embolism of deep vein thrombosis), assessed at 90 days
Key secondary outcome measure(s)	Current secondary outcome measures as of 15/01/2008: 1. Survival, assessed at 90 days 2. Major bleeding, assessed at 90 days 3. Wound infection, assessed at 90 days 4. Stroke, assessed at 90 days 5. Thrombocytopenia, assessed at 90 days 6. Cost effectiveness, assessed at 90 days Previous secondary outcome measures: 1. Survival, assessed at 90 days 2. Major bleeding, assessed at 90 days 3. Myocardial infarction, assessed at 90 days 4. Stroke, assessed at 90 days 5. Cost effectiveness, assessed at 90 days
Completion date	30/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2222
Key inclusion criteria	1. Patients undergoing elective total hip arthroplasty at the participating institutions 2. Age 18 years and older, either sex. However, please note that if a patient under 18 years presents to the clinic (although this is unlikely), they will be included.
Key exclusion criteria	Added as of 25/02/2009: 15. Investigator decision 16. Bilateral total hip arthroplasty (THA) or simultaneous hip and knee surgery 17. Unable to give consent 18. Geographical inaccessibility 19. Requirement for major surgery within 28 day study-drug period Amended as of 05/12/2007: 1. Hip fracture in the previous three months 2. Metastatic cancer 3. Life expectancy less than 6 months 4. History of major bleeding that, in the judgement of the investigator, precludes use of anticoagulant prophylaxis 5. History of aspirin allergy, active peptic ulcer disease or gastritis that, in the judgment of the investigator, precludes use of aspirin 6. History of heparin induced thrombocytopenia or heparin allergy 7. Creatine clearance less than 30 ml per minute 8. Platelet count less than 100 x 10^9/L 9. Need for long-term anticoagulation due to pre-existing co-morbid conditions or due to the development of venous thromboembolism following surgery but prior to randomisation 10. Need for aspirin over the course of the study due to pre-existing co-morbid condition 11. Previous participation in this study 12. Refusal to give informed consent 13. Did not, or will not, receive dalteparin post-operatively for Venous Thromboembolism (VTE) prophylaxis 14. Women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period Initial information at time of registration: 1. Hip fracture in the previous three months 2. Metastatic cancer 3. Life expectancy less than 6 months 4. History of major bleeding that, in the judgement of the investigator, precludes use of anticoagulant prophylaxis 5. History of aspirin allergy, active peptic ulcer disease or gastritis that, in the judgment of the investigator, precludes use of aspirin 6. History of heparin induced thrombocytopenia or heparin allergy 7. Chonic renal failure (creatine clearance less than 30 ml per minute) 8. Platelet count less than 100 x 10^9/L 9. Need for long-term anticoagulation due to pre-existing co-morbid conditions or due to the development of venous thromboembolism following surgery but prior to randomisation 10. Need for aspirin over the course of the study due to pre-existing co-morbid condition 11. Previous participation in this study 12. Geographic inaccessibility for follow-up 13. Refusal to give informed consent
Date of first enrolment	01/09/2007
Date of final enrolment	30/03/2011

Locations

Countries of recruitment

Canada

Study participating centre

Queen Elizabeth II (QEII) Health Sciences Centre and Dalhousie University

Halifax, Nova Scotia
B3H 2Y9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	04/06/2013		Yes	No