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 designInterventional, randomised, double blind (subject, caregiver, investigator and outcomes assessor), placebo-controlled, parallel assignment, safety/efficacy study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleLow 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 acronymPROTECT
Study objectivesTo 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) studiedCritical illness, deep vein thrombosis
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Dalteparin, unfractionated heparin
Primary outcome measureTo 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 measuresTo 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 date01/05/2006
Completion date12/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants3650
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2006
Date of final enrolment12/12/2010

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.