Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Deborah Cook
ORCID ID
Contact details
St Joseph's Hospital
50 Charlton Ave East
Martha Building
Rm H327
Hamilton
Ontario
L8N 4A6
Canada
+1 905 522 1155 ext. 35325
debcook@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00182143
Protocol/serial number
MCT-78568; ACTRN12606000090516
Study information
Scientific title
Low molecular weight heparin (LMWH) (dalteparin) versus unfractionated heparin (UFH) for deep vein thrombosis (DVT) prevention: a randomised, concealed, stratified, placebo-controlled, blinded, parallel assignment trial
Acronym
PROTECT
Study hypothesis
To evaluate the effect of low molecular weight heparin (LMWH) (dalteparin) versus unfractionated heparin (UFH) on the primary outcome of proximal leg deep vein thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of pulmonary embolism (PE), bleeding, heparin-induced thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.
Please note that this is a large-scale version of a previously registered pilot trial, 'PROphylaxis for ThromboEmbolism in Critical care Trial (PROTECT) pilot study' [ISRCTN54618366] (see http://www.controlled-trials.com/ISRCTN54618366). This large-scale version of the previous PROTECT Trial has been registered separately as changes to two of the exclusion criteria and one follow-up ultrasound of the protocol have been made between the pilot study and this large-scale trial.
As of 09/03/2009 this record was updated to include the addition of the United States of America as a country of recruitment, and an amended end date; the initial anticipated end date at the time of registration was 01/12/2011. All other changes can be found under the above date of update.
Ethics approval
1. Canada: Research Ethics Board of McMaster University, Hamilton, Ontario on the 21st November 2005 and 21st November 2007 (ref: 05-2572)
2. Australia: Ethics Committee of Alfred Hospital on the 1st December 2003 (initially) (ref: 181/03) and on the 9th January 2006 (ref: 236/05)
3. Brazil: Comitê de Ética, Santa Casa de Misericordian de Porto Alegre Hospital on the 27th July 2006 (ref: 1368/06) and the Comissâo Nacional de Ética em Pesquisa (CONEP), Ministério da saúde on the 20th August 2007 (ref: 620/2007)
4. Saudi Arabia: Institutional Review Board of King Faisal Specialist Hospital and Research Centre on the 13th March 2006 (initially) (ref: RC(J)103E/27) and on the 24th October 2007 (ref: RC(J) 334M/28)
Added 09/03/2009:
5. USA: Rhode Island Hospital IRB gave approval in April 2008
Study design
Interventional, randomised, double blind (subject, caregiver, investigator and outcomes assessor), placebo-controlled, parallel assignment, safety/efficacy study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Critical illness, deep vein thrombosis
Intervention
1. Drug: LMWH (dalteparin), 5,000 IU daily and placebo
2. Unfractionated heparin (UFH), 5,000 IU twice daily
The followup duration is to hospital discharge (which will vary for each patient).
Intervention type
Drug
Phase
Not Applicable
Drug names
Dalteparin, unfractionated heparin
Primary outcome measures
To evaluate the effect of LMWH (dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound. Time frame: while in ICU to a maximum of 90 days.
Secondary outcome measures
To evaluate the effect of LMWH (dalteparin) versus UFH on the secondary outcomes of PE, bleeding, HIT, and objectively confirmed venous thrombosis at any site. Time frame: while in ICU to a maximum of 90 days.
Overall trial start date
01/05/2006
Overall trial end date
12/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Admission to Intensive Care Unit (ICU)
2. Men or women greater than or equal to 18 years of age
3. Actual body weight greater than or equal to 45 kg
4. Admission to ICU expected to be greater than or equal to 72 hours in duration
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3650
Participant exclusion criteria
1. Trauma, post-orthopedic surgery or post-neurosurgery patients
2. Uncontrolled hypertension (systolic greater than 180 mmHg or diastolic greater than 110 mmHg)
3. Major haemorrhage, haemorrhagic stroke, DVT or PE on admission or within last three months
4. Coagulopathy as defined by international normalised ratio (INR) greater than two times upper limit of normal [ULN], or partial thromboplastin time (PTT) greater than two times ULN
5. Thrombocytopenia defined as platelet count less than or equal to 75 x 10^9/L
6. Need for oral or intravenous or subcutaneous therapeutic anticoagulation
7. Receipt of greater than three days of UFH or LMWH in ICU
8. Contraindication to heparin (e.g., suspected HIT), blood products or pork products
9. Pregnant or lactating
10. Withdrawal of life support or limitation of life support
11. Current enrolment in this trial or a related trial
12. Lack of informed consent
Recruitment start date
01/05/2006
Recruitment end date
12/12/2010
Locations
Countries of recruitment
Australia, Brazil, Canada, Saudi Arabia, United States of America
Trial participating centre
St Joseph's Hospital
Hamilton, Ontario
L8N 4A6
Canada
Sponsor information
Organisation
Hamilton Health Sciences (Canada)
Sponsor details
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78568)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary