PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

ISRCTN	ISRCTN94385648
DOI	https://doi.org/10.1186/ISRCTN94385648
ClinicalTrials.gov number	NCT00182143
Secondary identifying numbers	MCT-78568; ACTRN12606000090516

Submission date: 21/05/2008
Registration date: 21/05/2008
Last edited: 10/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Deborah Cook
Scientific

St Joseph's Hospital
50 Charlton Ave East
Martha Building, Rm H327
Hamilton, Ontario
L8N 4A6
Canada

Phone	+1 905 522 1155 ext. 35325
Email	debcook@mcmaster.ca

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	PROTECT
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/05/2006
Completion date	12/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	3650
Key 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
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	12/12/2010

Locations

Countries of recruitment

Australia
Brazil
Canada
Saudi Arabia
United States of America

Study participating centre

St Joseph's Hospital

Hamilton, Ontario
L8N 4A6
Canada

Sponsor information

Hamilton Health Sciences (Canada)
Research organisation

1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada

Website	http://www.hamiltonhealthsciences.ca/
"ROR"	https://ror.org/02dqdxm48

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78568)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	economic evaluation	20/12/2014	10/04/2019	Yes	No
Protocol article	protocol	01/04/2011	10/04/2019	Yes	No
Results article	results	01/06/2014	10/04/2019	Yes	No
Results article	results	01/12/2016	10/04/2019	Yes	No
Results article	results	01/12/2013	10/04/2019	Yes	No
Results article	results	07/04/2011	10/04/2019	Yes	No
Results article	results	01/09/2015	10/04/2019	Yes	No
Results article	results	01/10/2013	10/04/2019	Yes	No

Editorial Notes

10/04/2019: Publication reference added.