PROphylaxis of ThromboEmbolism in Critical care Trial (PROTECT) Trial: a pilot study
| ISRCTN | ISRCTN54618366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54618366 |
| ClinicalTrials.gov number | NCT00182143 |
| Secondary identifying numbers | MCT-57094 |
- Submission date
- 01/09/2005
- Registration date
- 01/09/2005
- Last edited
- 03/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 Joanne Cook
Scientific
Scientific
McMaster University
CE&B
HSC-2C11
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Phone | +1 905 525 9140 (22900) |
|---|---|
| debcook@mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised controlled pilot study on low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) in thromboembolism in critical care |
| Study acronym | PROTECT |
| Study objectives | We hypothesised that we would achieve the four feasibility objectives of the PROTECT Pilot. |
| Ethics approval(s) | McMaster University Research Ethics Board approved on the 14th March 2002. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Heparins |
| Primary outcome measure | 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 study start date | 01/02/2003 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 128 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Australia
- Canada
- Singapore
- United States of America
Study participating centre
McMaster University
Hamilton, Ontario
L8N 3Z5
Canada
L8N 3Z5
Canada
Sponsor information
McMaster University Medical Centre (Canada)
Hospital/treatment centre
Hospital/treatment centre
Department of Clinical Epidemiology and Biostatistics
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Phone | +1 905 525 9140 X 22900 |
|---|---|
| zytaruk@mcmaster.ca | |
"ROR" |
https://ror.org/05jyrng31 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-57094)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2005 | Yes | No |
