COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)
Scientific title
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)
Secondary ID [1] 0 0
Secondary ID [2] 0 0
54618366 PROTECT pilot
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Deep Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)

Treatment: Drugs: Fragmin (Dalteparin) LMWH verus Unfractionated Heparin (UFH)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
The primary outcome for the PROTECT Study is objectively confirmed proximal DVT (proven symptomatic or asymptomatic DVT) diagnosed by bilateral lower extremity compression ultrasound, confirmed by venography when possible.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
There are four secondary outcomes: 1) PE diagnosed by the PE Diagnosis algorithm, 2) bleeding, 3) anti-Xa levels associated with heparin dose adjustment, 4) thrombocytopenia and HIT
Timepoint [1] 0 0

Key inclusion criteria
1. Admission to ICU

2. Men and women greater than 18 years of age or older

3. Expected to remain in ICU admission greater than 72 hours
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Contraindications to LMWH or blood products

2. Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients,

3. Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a
diastolic blood pressure > 110 mmHg,

4. Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months,

5. Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times

6. Renal insufficiency as defined by a creatinine clearance <30ml/min,

7. A need for oral or intravenous or subcutaneous therapeutic anticoagulation,

8. Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT),

9. Receipt of >2 doses of UFH or LMWH in ICU,

10. Pregnant or lactating,

11. Withdrawal of life support or limitation of life support,

12. Prior enrollment in this trial

13. Prior enrollment into a related RCT

14. Thrombocytopenia defined platelet count < 100 x 109/L,

15. Bilateral lower limb amputation,

16. Allergy to pork or pork products

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Royal North Shore Hospital of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0
Nova Scotia
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
State/province [3] 0 0

Funding & Sponsors
Primary sponsor type
Hamilton Health Sciences Corporation
Other collaborator category [1] 0 0
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Name [2] 0 0
Canadian Critical Care Trials Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Brief summary
PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment 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, and 4) recruitment rates for a future randomized trial.
Trial website
Trial related presentations / publications
Clarke F, McDonald E, Rocker G, Cook DJ. Research coordinator activities in the ICU: An observational study. Abstract #108. Crit Care Med 2004;31(12)(suppl):A26.
Public notes

Principal investigator
Name 0 0
Deborah J Cook, MD
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications