Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Collaborators: Carmel Medical Center; Rambam Health Care Campus; Soroka University Medical Center; Tel Aviv Medical Center
• Treatments: Calcium heparin; Enoxaparin; Heparin; Warfarin

Criteria

Inclusion Criteria:

• Patients at moderate-high risk of VTE

• Patient aged 40-75 undergoing colonoscopy

• On warfarin therapy

Exclusion Criteria:

• Pregnancy

• Known Polyps > 10 mm

• Baseline Anemia < 10 gr%

• NOACs based anticoagulation

• Concomitant Mandatory Aspirin therapy (in 6 months period following ACS)

• Dual antiplatelet therapy

• Known bleeding diathesis

• Severe hepatic or renal impairment

• Previous history of procedure related major bleeding

• History of noncompliance to medical therapy

• Prior HIT

• Included in another clinical trial

• Inability to comply with written daily reporting on dedicated