PMID- 21482348
OWN - NLM
STAT- MEDLINE
DCOM- 20110915
LR  - 20131121
IS  - 1557-8615 (Electronic)
IS  - 0883-9441 (Linking)
VI  - 26
IP  - 2
DP  - 2011 Apr
TI  - PROphylaxis for ThromboEmbolism in Critical Care Trial protocol and analysis 
      plan.
PG  - 223.e1-9
LID - 10.1016/j.jcrc.2011.02.010 [doi]
AB  - BACKGROUND: This article reports the preparatory studies as well as the design, 
      implementation, and a priori analysis plans of PROphylaxis for ThromboEmbolism in 
      Critical Care Trial (PROTECT) before dissemination of results. PROphylaxis for 
      ThromboEmbolism in Critical Care Trial (NCT00182143) is a randomized, stratified, 
      concealed international trial comparing subcutaneous injection of unfractionated 
      heparin (UFH) 5000 IU or the low-molecular weight heparin (LMWH) dalteparin 5000 
      IU once daily plus once-daily placebo for the duration of the intensive care unit 
      stay. METHODS: The objective of PROTECT is to examine, among medical-surgical 
      critically ill patients, the effect of the LMWH vs heparin on the primary outcome 
      of proximal leg deep vein thrombosis (DVT) and the following secondary outcomes: 
      DVT elsewhere, pulmonary embolism, any venous thromboembolism (DVT or pulmonary 
      embolism), the composite of venous thromboembolism or death, bleeding, and 
      heparin-induced thrombocytopenia. Patients are followed up to death or hospital 
      discharge. Venous thromboembolism events were included after intensive care unit 
      discharge. All patients, families, clinicians, research personnel, and the trial 
      biostatistician are blind to allocation. RESULTS: We describe the pilot work, 
      large trial methodology, implementation methods, and the analytic plan. Patient 
      recruitment is complete, but 2 patients remain in the hospital. The rigorous 
      design of PROTECT suggests that the risk of systematic error will be low. The 
      sample size suggests that the risk of random error will be low. PROTECT will be 
      the largest investigator-initiated peer-review funded thromboprophylaxis trial in 
      critical care in the world. CONCLUSIONS: If PROTECT shows that LMWH is more 
      effective than UFH, this trial will change practice in that LMWH may be the 
      anticoagulant thromboprophylaxis of choice for this population. If the results 
      show that UFH is as effective or more effective than LMWH, intensivists in many 
      parts of the world may continue to use UFH, whereas those currently using LMWH 
      may reconsider and change to use UFH. Unfavorable consequences such as major 
      bleeding, ease of use, and the costs of complications will also factor into such 
      decisions.
CI  - Copyright (c) 2011 Elsevier Inc. All rights reserved.
FAU - Cook, Deborah
AU  - Cook D
AD  - Department of Medicine, McMaster University, Hamilton, Ontario, Canada L8N 3Z5. 
      debcook@mcmaster.ca
FAU - Meade, Maureen
AU  - Meade M
FAU - Guyatt, Gordon
AU  - Guyatt G
FAU - Walter, Stephen D
AU  - Walter SD
FAU - Heels-Ansdell, Diane
AU  - Heels-Ansdell D
FAU - Geerts, William
AU  - Geerts W
FAU - Warkentin, Theodore E
AU  - Warkentin TE
FAU - Cooper, D Jamie
AU  - Cooper DJ
FAU - Zytaruk, Nicole
AU  - Zytaruk N
FAU - Vallance, Shirley
AU  - Vallance S
FAU - Berwanger, Otavio
AU  - Berwanger O
FAU - Rocha, Marcelo
AU  - Rocha M
FAU - Qushmaq, Ismael
AU  - Qushmaq I
FAU - Crowther, Mark
AU  - Crowther M
LA  - eng
SI  - ClinicalTrials.gov/NCT00182143
GR  - Canadian Institutes of Health Research/Canada
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Crit Care
JT  - Journal of critical care
JID - 8610642
RN  - 0 (Fibrinolytic Agents)
RN  - 9005-49-6 (Heparin)
RN  - S79O08V79F (Dalteparin)
SB  - IM
MH  - *Critical Care
MH  - Dalteparin/administration & dosage/adverse effects/*therapeutic use
MH  - Fibrinolytic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Heparin/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Intensive Care Units
MH  - Multicenter Studies as Topic
MH  - Pulmonary Embolism/prevention & control
MH  - Randomized Controlled Trials as Topic
MH  - Research Design
MH  - Venous Thrombosis/*prevention & control
EDAT- 2011/04/13 06:00
MHDA- 2011/09/16 06:00
CRDT- 2011/04/13 06:00
PHST- 2011/01/10 00:00 [received]
PHST- 2011/02/04 00:00 [revised]
PHST- 2011/02/21 00:00 [accepted]
PHST- 2011/04/13 06:00 [entrez]
PHST- 2011/04/13 06:00 [pubmed]
PHST- 2011/09/16 06:00 [medline]
AID - S0883-9441(11)00081-5 [pii]
AID - 10.1016/j.jcrc.2011.02.010 [doi]
PST - ppublish
SO  - J Crit Care. 2011 Apr;26(2):223.e1-9. doi: 10.1016/j.jcrc.2011.02.010.