drugset / Trial / NCT02375646

Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients

NCT02375646

RandomizedParallel-groupSingle-blindPrevention

Summary

One of the well-known of complications post colonic polypectomy is bleeding usually occuring in the 2-week period following the procedure. Patients treated with oral anticoagulation (e.g. Warfarin) are a special and challenging patient group due to the need on the one hand to prevent thromboembolic events, and on the second hand to minimize the risk of post-polypectomy bleeding. Current practice guidelines recommend holding Warfarin treatment while bridging with LMW Heparin while resuming Warfarin treatment following the procedure. This practice was found to be associated with a much higher rate of bleeding compared with continuing Warfarin in a recent prospective trial in pacemaker transplanted patients. The fact that most post-polypectomy bleeding occurs within the 2-week period further questions the current practice of periprocedural bridging therapy. the investigators therefore hypothesize that patients with continuous Warfarin treatment may have similar post-polypectomy bleeding rates compared to patients receiving bridging therapy with LMW Heparin. This is a multicenter single-blinded prospective randomized trial comparing small post-polypectomy (polyps\<10mm) bleeding rates between two groups of patients: Continuous therapy with Warfarin, vs. LMW Heparin therapy while withholding Warfarin therapy (current practice).

Timeline

Start
2015-05
Primary completion
2017-05
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous
Subject Warfarin Small molecule Oral

Indications

No indication recorded.