PMID- 16310609
OWN - NLM
STAT- MEDLINE
DCOM- 20060316
LR  - 20071115
IS  - 0883-9441 (Print)
IS  - 0883-9441 (Linking)
VI  - 20
IP  - 4
DP  - 2005 Dec
TI  - Prophylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study.
PG  - 364-72
AB  - PURPOSE: There is no randomized trial comparing low-molecular weight heparin 
      (LMWH) and unfractionated heparin (UFH) for thromboprophylaxis in 
      medical-surgical ICU patients. The primary objective of this randomized pilot 
      study on LMWH vs UFH was to assess the feasibility of conducting a large 
      randomized trial with respect to timely enrollment and blinded study drug 
      administration, practicality of twice-weekly lower limb ultrasounds to screen for 
      deep venous thrombosis, LMWH bioaccumulation and dose adjustment in renal 
      insufficiency, and recruitment rates for a future trial in medical-surgical 
      intensive care unit (ICU) patients. Its additional goals were to evaluate the 
      suitability of the exclusion criteria and to document the range of research 
      activities that precede accrual of patients into a trial to plan multisite 
      management. MATERIALS AND METHODS: By computerized telephone randomization, we 
      allocated 129 medical-surgical ICU patients to treatment with dalteparin 5,000 IU 
      QD SC or that with UFH 5,000 IU BID SC. Within each clinical center, only the 
      study pharmacist was not blinded. We performed bilateral lower limb compression 
      ultrasounds within 48 hours of ICU admission, twice weekly, on suspicion of deep 
      venous thrombosis, and 7 days after ICU discharge. Research coordinators and 
      investigators at 7 centers reported the time they engaged in all research 
      activities before the first patient was randomized. RESULTS: Timely complete 
      study drug administration occurred after enrollment. More than 99% of scheduled 
      doses were administered in a blinded fashion. Scheduled ultrasounds were 
      performed without exception. No bioaccumulation of dalteparin was observed when 
      creatinine clearance decreased to lower than 30 mL/min. Average recruitment was 2 
      patients/center per month before the study exclusion criteria were modified. 
      Study startup activities required, on average, 65.5 hours of combined 
      investigator and research coordinator time at each center. Careful examination of 
      the accrual in the pilot study led to a reexamination of the Prophylaxis of 
      Thromboembolism in Critical Care Trial (PROTECT) study exclusion criteria. 
      CONCLUSIONS: This pilot study suggests that a multicenter randomized clinical 
      trial comparing LMWH with UFH in critically ill medical-surgical patients is 
      feasible. Pilot studies can improve the design of larger trials and may enhance 
      successful timely completion.
FAU - Cook, Deborah J
AU  - Cook DJ
AD  - Department of Medicine, McMaster University, Hamilton, Ontario, Canada L8N 3Z5. 
      debcook@mcmaster.ca
FAU - Rocker, Graeme
AU  - Rocker G
FAU - Meade, Maureen
AU  - Meade M
FAU - Guyatt, Gordon
AU  - Guyatt G
FAU - Geerts, William
AU  - Geerts W
FAU - Anderson, David
AU  - Anderson D
FAU - Skrobik, Yoanna
AU  - Skrobik Y
FAU - Hebert, Paul
AU  - Hebert P
FAU - Albert, Martin
AU  - Albert M
FAU - Cooper, Jamie
AU  - Cooper J
FAU - Bates, Shannon
AU  - Bates S
FAU - Caco, Christopher
AU  - Caco C
FAU - Finfer, Simon
AU  - Finfer S
FAU - Fowler, Robert
AU  - Fowler R
FAU - Freitag, Andreas
AU  - Freitag A
FAU - Granton, John
AU  - Granton J
FAU - Jones, Graham
AU  - Jones G
FAU - Langevin, Stephan
AU  - Langevin S
FAU - Mehta, Sangeeta
AU  - Mehta S
FAU - Pagliarello, Giuseppe
AU  - Pagliarello G
FAU - Poirier, Germain
AU  - Poirier G
FAU - Rabbat, Christian
AU  - Rabbat C
FAU - Schiff, David
AU  - Schiff D
FAU - Griffith, Lauren
AU  - Griffith L
FAU - Crowther, Mark
AU  - Crowther M
CN  - PROTECT Investigators
CN  - Canadian Critical Care Trials Group
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Crit Care
JT  - Journal of critical care
JID - 8610642
RN  - 0 (Anticoagulants)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Anticoagulants/*therapeutic use
MH  - Australia
MH  - Canada
MH  - Double-Blind Method
MH  - Female
MH  - Heparin/*therapeutic use
MH  - Heparin, Low-Molecular-Weight/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Randomized Controlled Trials as Topic/*methods
MH  - *Research Design
MH  - Venous Thrombosis/*prevention & control
EDAT- 2005/11/29 09:00
MHDA- 2006/03/17 09:00
CRDT- 2005/11/29 09:00
PHST- 2005/08/01 00:00 [received]
PHST- 2005/08/31 00:00 [revised]
PHST- 2005/09/08 00:00 [accepted]
PHST- 2005/11/29 09:00 [pubmed]
PHST- 2006/03/17 09:00 [medline]
PHST- 2005/11/29 09:00 [entrez]
AID - S0883-9441(05)00091-2 [pii]
AID - 10.1016/j.jcrc.2005.09.010 [doi]
PST - ppublish
SO  - J Crit Care. 2005 Dec;20(4):364-72. doi: 10.1016/j.jcrc.2005.09.010.