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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00182143
Registration number
NCT00182143
Ethics application status
Date submitted
10/09/2005
Date registered
16/09/2005
Date last updated
10/01/2011
Titles & IDs
Public title
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
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Scientific title
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
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Secondary ID [1]
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ISRCTN54618366
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Deep Venous Thrombosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LMWH (Fragmin, dalteparin)
Treatment: Drugs - Unfractionated Heparin
Active comparator: LMWH (Fragmin, dalteparin) - Placebo dose (normal saline) = AM dose LMWH (Fragmin, dalteparin) 5000IU daily = PM dose
Active comparator: 2 - Unfractionated Heparin 5000IU BID
Treatment: Drugs: LMWH (Fragmin, dalteparin)
Placebo AM dose (normal saline) and LMWH (Fragmin, dalteparin) 5000IU PM dose
Treatment: Drugs: Unfractionated Heparin
5000 IU BID
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound
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Assessment method [1]
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Timepoint [1]
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While in ICU to a maximum of 90 days
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Secondary outcome [1]
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To evaluate the effect of LMWH (Fragmin, dalteparin) versus UFH on the secondary outcomes of PE, bleeding, HIT, and objectively confirmed venous thrombosis at any site
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Assessment method [1]
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Timepoint [1]
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While in ICU to a maximum of 90 days
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Eligibility
Key inclusion criteria
1. Patient is >/= 18 years of age
2. Actual body weight is >/= 45 kg
3. Admission to ICU expected to be >/= 72 hours in duration
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Neurosurgery within last 3 months
2. Ischemic stroke within last 3 months
3. Intracranial hemorrhage within last 3 months
4. Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion
5. Major hemorrhage within last week unless definitively treated
6. Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening
7. Thrombocytopenia defined as platelet count </= 75 x 109/L, at time of screening
8. Other heparin contraindications (e.g., HIT, pregnancy, lactating)
9. Contraindication to blood products (e.g., Jehovah's Witness)
10. Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)
11. Limitation of life support, Life expectancy </= 14 days, or palliative care
12. Contamination (e.g., >/= 3 doses of LMWH during this ICU admission)
13. Lack of informed consent
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
3659
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Nepean Hospital - Penrith
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Recruitment hospital [4]
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Wollongong Hospital - Wollongong
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [6]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [7]
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Flinders Hospital - Bedford Park
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Recruitment hospital [8]
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Bendigo Health Care - Bendigo
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Recruitment hospital [9]
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Box Hill Hospital - Box Hill
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Recruitment hospital [10]
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Monash Medical Center - Clayton
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Recruitment hospital [11]
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Dandenong Hospital - Dandenong
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Recruitment hospital [12]
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Frankston Hospital - Frankston
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Recruitment hospital [13]
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The Geelong Hospital - Geelong
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Recruitment hospital [14]
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Austin Hill Hospital - Heidelburg
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Recruitment hospital [15]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [16]
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The Alfred Hospital - Melbourne
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Recruitment hospital [17]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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- Camperdown
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Recruitment postcode(s) [3]
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- Penrith
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Recruitment postcode(s) [4]
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- Wollongong
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Recruitment postcode(s) [5]
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- Adelaide
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Recruitment postcode(s) [6]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [7]
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- Bedford Park
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Recruitment postcode(s) [8]
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- Bendigo
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Recruitment postcode(s) [9]
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- Box Hill
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Recruitment postcode(s) [10]
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- Clayton
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Recruitment postcode(s) [11]
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3168 - Dandenong
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Recruitment postcode(s) [12]
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- Frankston
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Recruitment postcode(s) [13]
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3220 - Geelong
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Recruitment postcode(s) [14]
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- Heidelburg
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Recruitment postcode(s) [15]
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3101 - Melbourne
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Recruitment postcode(s) [16]
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3181 - Melbourne
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Recruitment postcode(s) [17]
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NSW 2065 - St Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Minnesota
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United States of America
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State/province [2]
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Missouri
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United States of America
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Rhode Island
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United States of America
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Texas
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Brazil
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Rs Cep
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Brazil
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RS
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Brazil
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State/province [7]
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Rio de Janeiro
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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State/province [10]
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British Columbia
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Canada
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State/province [11]
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Manitoba
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Canada
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State/province [12]
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Nova Scotia
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Canada
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State/province [13]
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Ontario
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Country [14]
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Canada
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State/province [14]
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Quebec
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Country [15]
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Saudi Arabia
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State/province [15]
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Riyahd
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Country [16]
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Saudi Arabia
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State/province [16]
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Jeddah
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Saudi Arabia
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State/province [17]
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Riyadh
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Country [18]
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United Kingdom
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State/province [18]
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England
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Canadian Critical Care Trials Group
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Australian and New Zealand Intensive Care Society Clinical Trials Group
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, 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.
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Trial website
https://clinicaltrials.gov/study/NCT00182143
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Trial related presentations / publications
Li G, Cook DJ, Thabane L, Friedrich JO, Crozier TM, Muscedere J, Granton J, Mehta S, Reynolds SC, Lopes RD, Lauzier F, Freitag AP, Levine MA; PROTECT Investigators for the Canadian Critical Care Trials Group, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Risk factors for mortality in patients admitted to intensive care units with pneumonia. Respir Res. 2016 Jul 11;17(1):80. doi: 10.1186/s12931-016-0397-5. Erratum In: Respir Res. 2016 Oct 7;17(1):128. doi: 10.1186/s12931-016-0444-2. Li G, Thabane L, Cook DJ, Lopes RD, Marshall JC, Guyatt G, Holbrook A, Akhtar-Danesh N, Fowler RA, Adhikari NKJ, Taylor R, Arabi YM, Chittock D, Dodek P, Freitag AP, Walter SD, Heels-Ansdell D, Levine MAH. Risk factors for and prediction of mortality in critically ill medical-surgical patients receiving heparin thromboprophylaxis. Ann Intensive Care. 2016 Dec;6(1):18. doi: 10.1186/s13613-016-0116-x. Epub 2016 Feb 27. Li G, Cook DJ, Levine MAH, Guyatt G, Crowther M, Heels-Ansdell D, Holbrook A, Lamontagne F, Walter SD, Ferguson ND, Finfer S, Arabi YM, Bellomo R, Cooper DJ, Thabane L; PROTECT Investigators for the Canadian Critical Care Trials Group, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Competing Risk Analysis for Evaluation of Dalteparin Versus Unfractionated Heparin for Venous Thromboembolism in Medical-Surgical Critically Ill Patients. Medicine (Baltimore). 2015 Sep;94(36):e1479. doi: 10.1097/MD.0000000000001479. Fowler RA, Mittmann N, Geerts WH, Heels-Ansdell D, Gould MK, Guyatt G, Krahn M, Finfer S, Pinto R, Chan B, Ormanidhi O, Arabi Y, Qushmaq I, Rocha MG, Dodek P, McIntyre L, Hall R, Ferguson ND, Mehta S, Marshall JC, Doig CJ, Muscedere J, Jacka MJ, Klinger JR, Vlahakis N, Orford N, Seppelt I, Skrobik YK, Sud S, Cade JF, Cooper J, Cook D; Canadian Critical Care Trials Group; Australia and New Zealand Intensive Care Society Clinical Trials Group. Economic evaluation of the prophylaxis for thromboembolism in critical care trial (E-PROTECT): study protocol for a randomized controlled trial. Trials. 2014 Dec 20;15:502. doi: 10.1186/1745-6215-15-502. Crowther M, Cook D, Guyatt G, Zytaruk N, McDonald E, Williamson D, Albert M, Dodek P, Finfer S, Vallance S, Heels-Ansdell D, McIntyre L, Mehta S, Lamontagne F, Muscedere J, Jacka M, Lesur O, Kutsiogiannis J, Friedrich J, Klinger JR, Qushmaq I, Burry L, Khwaja K, Sheppard JA, Warkentin TE; PROTECT collaborators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group. Heparin-induced thrombocytopenia in the critically ill: interpreting the 4Ts test in a randomized trial. J Crit Care. 2014 Jun;29(3):470.e7-15. doi: 10.1016/j.jcrc.2014.02.004. Epub 2014 Feb 14. Lamontagne F, McIntyre L, Dodek P, Heels-Ansdell D, Meade M, Pemberton J, Skrobik Y, Seppelt I, Vlahakis NE, Muscedere J, Reece G, Ostermann M, Padayachee S, Alhashemi J, Walsh M, Lewis B, Schiff D, Moody A, Zytaruk N, Leblanc M, Cook DJ; Prophylaxis for Thromboembolism in Critical Care Trial Investigators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group. Nonleg venous thrombosis in critically ill adults: a nested prospective cohort study. JAMA Intern Med. 2014 May;174(5):689-96. doi: 10.1001/jamainternmed.2014.169. Lauzier F, Arnold DM, Rabbat C, Heels-Ansdell D, Zarychanski R, Dodek P, Ashley BJ, Albert M, Khwaja K, Ostermann M, Skrobik Y, Fowler R, McIntyre L, Nates JL, Karachi T, Lopes RD, Zytaruk N, Finfer S, Crowther M, Cook D. Risk factors and impact of major bleeding in critically ill patients receiving heparin thromboprophylaxis. Intensive Care Med. 2013 Dec;39(12):2135-43. doi: 10.1007/s00134-013-3044-3. Epub 2013 Aug 14. Smith OM, McDonald E, Zytaruk N, Foster D, Matte A, Clarke F, Fleury S, Krause K, McArdle T, Skrobik Y, Cook DJ. Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial. Intensive Crit Care Nurs. 2013 Dec;29(6):300-9. doi: 10.1016/j.iccn.2013.04.006. Epub 2013 Jul 18. Williamson DR, Albert M, Heels-Ansdell D, Arnold DM, Lauzier F, Zarychanski R, Crowther M, Warkentin TE, Dodek P, Cade J, Lesur O, Lim W, Fowler R, Lamontagne F, Langevin S, Freitag A, Muscedere J, Friedrich JO, Geerts W, Burry L, Alhashemi J, Cook D; PROTECT collaborators, the Canadian Critical Care Trials Group, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Thrombocytopenia in critically ill patients receiving thromboprophylaxis: frequency, risk factors, and outcomes. Chest. 2013 Oct;144(4):1207-1215. doi: 10.1378/chest.13-0121. Smith OM, McDonald E, Zytaruk N, Foster D, Matte A, Clarke F, Meade L, O'Callaghan N, Vallance S, Galt P, Rajbhandari D, Rocha M, Mehta S, Ferguson ND, Hall R, Fowler R, Burns K, Qushmaq I, Ostermann M, Heels-Ansdell D, Cook D; PROTECT Research Coordinators; PROTECT Investigators; Canadian Critical Care Trials Group; Australian, New Zealand Intensive Care Society Clinical Trials Group. Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial. J Crit Care. 2013 Feb;28(1):28-39. doi: 10.1016/j.jcrc.2012.08.005. Epub 2012 Oct 22. Cook D, Meade M, Guyatt G, Walter SD, Heels-Ansdell D, Geerts W, Warkentin TE, Cooper DJ, Zytaruk N, Vallance S, Berwanger O, Rocha M, Qushmaq I, Crowther M. PROphylaxis for ThromboEmbolism in Critical Care Trial protocol and analysis plan. J Crit Care. 2011 Apr;26(2):223.e1-9. doi: 10.1016/j.jcrc.2011.02.010. PROTECT Investigators for the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Cook D, Meade M, Guyatt G, Walter S, Heels-Ansdell D, Warkentin TE, Zytaruk N, Crowther M, Geerts W, Cooper DJ, Vallance S, Qushmaq I, Rocha M, Berwanger O, Vlahakis NE. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2011 Apr 7;364(14):1305-14. doi: 10.1056/NEJMoa1014475. Epub 2011 Mar 22.
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Public notes
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Contacts
Principal investigator
Name
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Deborah J Cook, MD
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Address
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McMaster University
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00182143
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