PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
| ISRCTN | ISRCTN94385648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94385648 |
| ClinicalTrials.gov (NCT) | NCT00182143 |
| Protocol serial number | MCT-78568; ACTRN12606000090516 |
| Sponsor | Hamilton Health Sciences (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78568) |
- 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
Contact information
Dr Deborah Cook
Scientific
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 |
|---|---|
| debcook@mcmaster.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, randomised, double blind (subject, caregiver, investigator and outcomes assessor), placebo-controlled, parallel assignment, safety/efficacy study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dalteparin, unfractionated heparin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 12/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
L8N 4A6
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 | 01/06/2014 | 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 |
| Protocol article | protocol | 01/04/2011 | 10/04/2019 | Yes | No |
| Other publications | economic evaluation | 20/12/2014 | 10/04/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/04/2019: Publication reference added.
