Anticoagulation of Calf Thrombosis (ACT): A Pilot Feasibility Study

• Research type

  Research Study

• Full title

  The Anticoagulation of Calf Thrombosis (ACT) Study: A randomised controlled trial comparing standardised anticoagulation versus conservative therapy in the treatment of below knee deep vein thrombosis.

• IRAS ID

  56621

• Contact name

  Daniel Horner

• Sponsor organisation

  Central Manchester University Hospitals NHS Foundation Trust

• Eudract number

  2010-021813-22

• Research summary

  The treatment of a blood clot in the leg below the level of the knee is a long debated topic. There is ongoing discussion about whether to treat this condition actively with drugs to thin the blood (anticoagulants) or to simply 'watch and wait'. Both approaches are utilised at different hospitals in the North West. Some hospitals 'watch and wait' only. They scan the leg 1 week after presentation, treating only if the clot gets bigger. Several research studies suggest this is as safe an approach as treating the clot. It also avoids exposing patients to the inherent risks of blood thinning drugs. Other hospitals worry about the chance of the clot moving up the leg and rarely into the lungs. They practice treating all patients with anticoagulants to reduce these risks as much as possible. This also means that patients do not have to come back in a weeks’ time for another scan. Although some risk may be reduced by this approach, there is a potential for anticoagulant drugs to cause harm. This research is trying to find out which approach is safest for patients. To find this out, we propose to randomly allocate patients with below knee blood clots to receive conservative treatment, (stocking supports and simple painkillers), or conservative treatment and anticoagulation. All patients will receive serial leg scans and be followed closely. Short-term assessment and long term follow up will occur. If the trial shows a benefit from treating below knee clots, this will have a major impact on those hospitals which only scan above the knee, as many currently do. If the trial shows no benefit to treating the clots, many patients will be able to avoid the dangers of anticoagulation and further risk.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/97

• Date of REC Opinion

  23 Dec 2010

• REC opinion

  Further Information Favourable Opinion