Introduction: There is considerable uncertainty over whether graduated compression stockings are useful for the prevention of post stroke DVT. This uncertainty translates into variation in practice across centres.
CLOTS aims to address the following two questions:
Trial 1. Does early and routine application of full length GCS reduce the risk of above knee DVT in the weeks following acute stroke?
Trial 2. Are full length GCS more effective than below knee GCS in reducing the risk of DVT?
Methods: Immobile patients admitted with an acute stroke can be randomised into Trial 1 to receive Full length GCS or No GCS or into Trial 2 to receive Full length GCS or Below Knee GCS. We collect baseline data via a telephone randomisation system. The primary outcome is DVT in proximal leg veins detected on either Doppler ultrasound or venography within 30 days of randomisation. Patients have screening Doppler ultrasounds between Days 7 and 10 and between Days 25 and 30. Data are collected at hospital discharge to monitor compliance and identify in hospital complications, deaths and length of stay. At six months surviving patients are followed up to establish post discharge thromboembolic events and their functional status.
Results: The trial is feasible, stroke unit nurses are willing and able to identify suitable patients, obtain informed consent and randomise the patients. Twenty eight centres in 5 countries have already enrolled over 350 patients.
Conclusions: We are proceeding with the main phase sponsored by the Medical Research Council (UK) from 1/10/2003 to 30/09/2009 which will include over 5000 patients. We are seeking collaborating centres. www.clotstrial.com