Contact information
Type
Scientific
Primary contact
Dr Deborah Joanne Cook
ORCID ID
Contact details
McMaster University
CE&B
HSC-2C11
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140 (22900)
debcook@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00182143
Protocol/serial number
MCT-57094
Study information
Scientific title
A randomised controlled pilot study on low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) in thromboembolism in critical care
Acronym
PROTECT
Study hypothesis
We hypothesised that we would achieve the four feasibility objectives of the PROTECT Pilot.
Ethics approval
McMaster University Research Ethics Board approved on the 14th March 2002.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Medical-surgical Intensive Care Unit (ICU) patients
Intervention
LMWH (dalteparin 5000 IU once daily and placebo once daily) or UFH (5000 IU twice daily).
Intervention type
Drug
Phase
Not Applicable
Drug names
Heparins
Primary outcome measure
Scientific:
To establish the effect of LMWH versus UFH on DVT rates in medical-surgical ICU patients.
Feasibility:
1. The feasibility of timely enrolment and complete, blinded study drug administration
2. The bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding
3. The feasibility of scheduled twice weekly lower limb ultrasounds
4. Recruitment rates for a future randomised trial
Secondary outcome measures
Scientific:
Among medical-surgical ICU patients, to establish the effect of LMWH versus UFH:
1. On PE (PE diagnosed by the PE diagnosis algorithm)
2. On bleeding events
3. On anti-Xa levels, and thus, the need for dose adjustment
4. On thrombocytopenia and heparin-induced thrombocytopenia
Overall trial start date
01/02/2003
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Admission to Intensive Care Unit (ICU)
2. Either sex, 18 years of age or over
3. Expected ICU admission more than or equal to 72 hours
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128
Participant exclusion criteria
1. Diagnosis of trauma, post-orthopedic surgery, or neurosurgery at ICU admission
2. Severe hypertension (systolic blood pressure more than or equal to 180 mmHg for two hours or more) at ICU admission. Intracranial haemorrhage at ICU admission or within three months.
3. Known deep vein thrombosis (DVT), pulmonary embolism (PE) or major haemorrhage at ICU admission. Coagulopathy (defined as international normalised ratio [INR] values more than or equal to two times upper limit of normal).
4. Platelet count more than or equal to 50 x 10^9/l. Current therapeutic oral or intravenous anticoagulation for any reason. Current administration of activated protein. Estimated creatinine clearance less than or equal to 30 ml/min.
5. History of allergy to heparin or heparin-induced thrombocytopenia (HIT)
6. Receipt more than or equal to two doses of either low molecular weight heparin (LMWH) or unfractionated heparin (UFH) in ICU or Critical Care Unit (CCU)
7. Pregnancy
8. Limitation of life support or palliative care
9. No informed consent
10. Prior enrolment in this trial or currently in another related randomised trial
Recruitment start date
01/02/2003
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Australia, Canada, Singapore, United States of America
Trial participating centre
McMaster University
Hamilton, Ontario
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University Medical Centre (Canada)
Sponsor details
Department of Clinical Epidemiology and Biostatistics
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140 X 22900
zytaruk@mcmaster.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-57094)
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
Basic results (scientific)
Publication list
2005 results on http://www.ncbi.nlm.nih.gov/pubmed/16310609
Publication citations
-
Results
Cook DJ, Rocker G, Meade M, Guyatt G, Geerts W, Anderson D, Skrobik Y, Hebert P, Albert M, Cooper J, Bates S, Caco C, Finfer S, Fowler R, Freitag A, Granton J, Jones G, Langevin S, Mehta S, Pagliarello G, Poirier G, Rabbat C, Schiff D, Griffith L, Crowther M, , , Prophylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study., J Crit Care, 2005, 20, 4, 364-372, doi: 10.1016/j.jcrc.2005.09.010.