BRIDGE
Bridging Anticoagulation in Patients Who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (“BRIDGE”)
Approval Date: 9/9/2009
Principal Investigator: Brian Williamson, M.D.
This clinical research study is being sponsored by a grant from the National Institute of Health. People, who require an interruption of their warfarin therapy because of surgery or a procedure, usually stop taking warfarin about 5 days before the surgery. This is done because it takes about 5 days for the blood thinning effect of warfarin to wear off and be eliminated from the body. Warfarin needs to be stopped in order to prevent too much bleeding from occurring during and after surgery. When warfarin is re-started after surgery, it takes about 5-7 days for the blood thinning effect to return. As a result, during this time period the blood thinning effect of warfarin is less than desired. Since interrupting warfarin before and after surgery reduces the blood thinning effect and may increase the risk for blood clots, some doctors choose to administer a blood thinner that works quickly but also wears off quickly. Use of this short acting blood thinner is referred to as "bridging anticoagulation". At this time, there is no agreement among experts and practicing physicians regarding whether bridging anticoagulation should be used. Some doctors give bridging anticoagulation to prevent the formation of blood clots during interruption of warfarin, however some doctors do not give bridging anticoagulation because it might cause bleeding during (or after) surgery. This research study aims at determining the effectiveness and safety of giving a low molecular weight heparin (LMWH) called dalteparin (Fragmin®) as bridging anticoagulation to people with atrial fibrillation who require temporary interruption (stopping for a short time) of warfarin because of surgery or another procedure. It is not known whether bridging anticoagulation is helpful to patients who require temporary interruption of warfarin. On the one hand, bridging anticoagulation minimizes the time patients are not receiving blood thinning treatment prior to and after surgery and therefore may reduce their risk for developing a stroke or other types of blood clots. On the other hand, giving bridging anticoagulation may increase the risk for bleeding, which may be harmful. Such bleeding may require medical attention and may lead to other health problems. Overall, there is uncertainty about the benefit and harm of bridging anticoagulation. This research study is being done to help determine the possible benefits and harms of bridging anticoagulation and will inform doctors about the best way to care for patients in the future.
Eligibility:
“Each study has its own guidelines for who can participate, called ‘eligibility criteria.’ Below is a partial list of criteria for acceptance into the research study. Only the study doctor can make the determination that you meet all eligibility criteria.”
- Adult male or female, age 18 years or older
- Has been receiving warfarin therapy for at least 3 months, given to achieve an international normalized ratio (INR) range of 2.0-3.0
- Requires temporary interruption of warfarin for pre-specified elective procedure or surgery
- Have at least one of the following conditions:
- Have at least one of the following major stoke risk factors:
Contact Person:
Coleen Tessmar, RN, CCRP
248-964-8524
Status of Clinical Trial:
open and enrolling
