PROTECT

• Research type

  Research Study

• Full title

  PROphylaxis of ThromboEmbolism in Critical Care Trial

• IRAS ID

  15223

• Sponsor organisation

  McMaster University, Departments of Medicine, Clinical Epidemiology & Biostatistics

• Eudract number

  2009-012387-13

• ISRCTN Number

  xx

• Research summary

  Patients will undergo concealed random allocation to either LMWH (dalteparin 5,000 IU once daily) or unfractionated Heparin (UFH) 5,000 IU bid subcutaneously (control intervention). The control intervention represents standard thromboprophylaxis in Canada and Australia for these ICU patients, as has been documented in surveys [Cook 2001, Cooper 2005], cross-sectional studies [Cook 2001, Lacherade] and a longitudinal study [Cook 2003]. LMWH syringes will be prepared that contain 5,000 IU of dalteparin. UFH syringes will contain 5,000 IU of UFH. Syringes of LMWH and UFH will appear identical. Patients allocated to LMWH will also receive one placebo injection daily to maintain blinding. For patients allocated to LMWH, the first dose, or the morning dose in each study kit will always be placebo and nurses will administer the numbered doses sequentially. This is to optimize the likelihood that the patients enrolled later in the day into the LMWH arm will receive active drug on study day 1. Nurses will administer study drug at approximately 1100h ( hour) (placebo or UFH) and 2300h ( hour) (dalteparin or UFH). Study drug will be administered for the duration of the ICU stay.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/22

• Date of REC Opinion

  11 Jun 2009

• REC opinion

  Further Information Favourable Opinion