ISRCTN - ISRCTN94385648: PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

Plain English Summary

Not provided at time of registration

Trial website

http://clarityresearch.ca/protect/protect_trial/index.php

Contact information

Type

Scientific

Primary contact

Dr Deborah Cook

ORCID ID

Contact details

St Joseph's Hospital
50 Charlton Ave East
Martha Building
Rm H327
Hamilton
Ontario
L8N 4A6
Canada
+1 905 522 1155 ext. 35325
debcook@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00182143

Protocol/serial number

MCT-78568; ACTRN12606000090516

Study information

Scientific title

Low molecular weight heparin (LMWH) (dalteparin) versus unfractionated heparin (UFH) for deep vein thrombosis (DVT) prevention: a randomised, concealed, stratified, placebo-controlled, blinded, parallel assignment trial

Acronym

PROTECT

Study hypothesis

To evaluate the effect of low molecular weight heparin (LMWH) (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.

Please note that this is a large-scale version of a previously registered pilot trial, 'PROphylaxis for ThromboEmbolism in Critical care Trial (PROTECT) pilot study' [ISRCTN54618366] (see http://www.controlled-trials.com/ISRCTN54618366). This large-scale version of the previous PROTECT Trial has been registered separately as changes to two of the exclusion criteria and one follow-up ultrasound of the protocol have been made between the pilot study and this large-scale trial.

As of 09/03/2009 this record was updated to include the addition of the United States of America as a country of recruitment, and an amended end date; the initial anticipated end date at the time of registration was 01/12/2011. All other changes can be found under the above date of update.

Ethics approval

1. Canada: Research Ethics Board of McMaster University, Hamilton, Ontario on the 21st November 2005 and 21st November 2007 (ref: 05-2572)
2. Australia: Ethics Committee of Alfred Hospital on the 1st December 2003 (initially) (ref: 181/03) and on the 9th January 2006 (ref: 236/05)
3. Brazil: Comitê de Ética, Santa Casa de Misericordian de Porto Alegre Hospital on the 27th July 2006 (ref: 1368/06) and the Comissâo Nacional de Ética em Pesquisa (CONEP), Ministério da saúde on the 20th August 2007 (ref: 620/2007)
4. Saudi Arabia: Institutional Review Board of King Faisal Specialist Hospital and Research Centre on the 13th March 2006 (initially) (ref: RC(J)103E/27) and on the 24th October 2007 (ref: RC(J) 334M/28)

Added 09/03/2009:
5. USA: Rhode Island Hospital IRB gave approval in April 2008

Study design

Interventional, randomised, double blind (subject, caregiver, investigator and outcomes assessor), placebo-controlled, parallel assignment, safety/efficacy study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Critical illness, deep vein thrombosis

Intervention

1. Drug: LMWH (dalteparin), 5,000 IU daily and placebo
2. Unfractionated heparin (UFH), 5,000 IU twice daily

The followup duration is to hospital discharge (which will vary for each patient).

Intervention type

Drug

Phase

Not Applicable

Drug names

Dalteparin, unfractionated heparin

Primary outcome measure

To evaluate the effect of LMWH (dalteparin) versus UFH on the primary outcome of proximal leg DVT diagnosed by compression ultrasound. Time frame: while in ICU to a maximum of 90 days.

Secondary outcome measures

To evaluate the effect of LMWH (dalteparin) versus UFH on the secondary outcomes of PE, bleeding, HIT, and objectively confirmed venous thrombosis at any site. Time frame: while in ICU to a maximum of 90 days.

Overall trial start date

01/05/2006

Overall trial end date

12/12/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Admission to Intensive Care Unit (ICU)
2. Men or women greater than or equal to 18 years of age
3. Actual body weight greater than or equal to 45 kg
4. Admission to ICU expected to be greater than or equal to 72 hours in duration

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3650

Participant exclusion criteria

1. Trauma, post-orthopedic surgery or post-neurosurgery patients
2. Uncontrolled hypertension (systolic greater than 180 mmHg or diastolic greater than 110 mmHg)
3. Major haemorrhage, haemorrhagic stroke, DVT or PE on admission or within last three months
4. Coagulopathy as defined by international normalised ratio (INR) greater than two times upper limit of normal [ULN], or partial thromboplastin time (PTT) greater than two times ULN
5. Thrombocytopenia defined as platelet count less than or equal to 75 x 10^9/L
6. Need for oral or intravenous or subcutaneous therapeutic anticoagulation
7. Receipt of greater than three days of UFH or LMWH in ICU
8. Contraindication to heparin (e.g., suspected HIT), blood products or pork products
9. Pregnant or lactating
10. Withdrawal of life support or limitation of life support
11. Current enrolment in this trial or a related trial
12. Lack of informed consent

Recruitment start date

01/05/2006

Recruitment end date

12/12/2010

Locations

Countries of recruitment

Australia, Brazil, Canada, Saudi Arabia, United States of America

Trial participating centre

St Joseph's Hospital
Hamilton, Ontario
L8N 4A6
Canada

Sponsor information

Organisation

Hamilton Health Sciences (Canada)

Sponsor details

1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada

Sponsor type

Research organisation

Website

http://www.hamiltonhealthsciences.ca/

Funders

Funder type