BRUISE CONTROL
Research type
Research Study
Full title
BRUISE CONTROL : BRidge or continUe coumadIn for device SurgEry randomized CONTROLled Trial
IRAS ID
48148
Contact name
Kim Rajappan
Sponsor organisation
Oxford Radcliffe Hospitals NHS Trust
Eudract number
2010-024552-28
ISRCTN Number
ISRCTN11629886
Clinicaltrials.gov Identifier
Research summary
Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on chronic oral anticoagulation (OAC) therapy (usually warfarin). The management of their anticoagulation around surgery presents a dilemma to physicians. This is particularly true in patients at highest risk of forming blood clots (thrombo-embolic events). On one side of the dilemma is the risk of blood clot formation related to stopping oral anti-coagulant therapy. On the other side of the dilemma is the risk of a pocket haematoma (blood collection) forming related to using bridging heparin therapy. The risk of pocket haematoma using bridging with heparin has been shown to be between 8 and 30.5 %. Developing a pocket haematoma can result in the following: require stopping of heparin with the risk of a blood clot elsewhere in the body; cause pain and can significantly prolong hospital stay; and sometimes re-operation is required. Re-operation within a few days of the initial implantation procedure can increase the risk of subsequent device system infection. Despite these risks, the accepted standard of care or routine treatment in most centres is to use bridging heparin therapy in patients with a moderate to high risk of forming blood clots. Recently in response to these issues a number of centres have explored the option of performing device surgery without stopping OAC. The purpose of the Bruise Control study is to compare the current accepted standard of care or treatment, (of bridging with Heparin), with a strategy where patients will continue on warfarin.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
12/SC/0061
Date of REC Opinion
3 Dec 2012
REC opinion
Further Information Favourable Opinion