Condition category
Surgery
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2005 results on http://www.ncbi.nlm.nih.gov/pubmed/16310609

Publication citations

  1. 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.

Additional files

Editorial Notes