PROphylaxis of ThromboEmbolism in Critical care Trial (PROTECT) Trial: a pilot study

ISRCTN	ISRCTN54618366
DOI	https://doi.org/10.1186/ISRCTN54618366
ClinicalTrials.gov (NCT)	NCT00182143
Protocol serial number	MCT-57094
Sponsor	McMaster University Medical Centre (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-57094)

Submission date: 01/09/2005
Registration date: 01/09/2005
Last edited: 03/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Deborah Joanne Cook
Scientific

McMaster University
CE&B
HSC-2C11
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada

Phone	+1 905 525 9140 (22900)
Email	debcook@mcmaster.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled pilot study on low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) in thromboembolism in critical care
Study acronym	PROTECT
Study objectives	We hypothesised that we would achieve the four feasibility objectives of the PROTECT Pilot.
Ethics approval(s)	McMaster University Research Ethics Board approved on the 14th March 2002.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Heparins
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	128
Key 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
Key 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
Date of first enrolment	01/02/2003
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Australia
Canada
Singapore
United States of America

Study participating centre

McMaster University

Hamilton, Ontario
L8N 3Z5
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	01/12/2005		Yes	No