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Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients

NCT02375646 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2015-03-02

No results posted yet for this study

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).

Conditions

  • Post Polypectomy Bleeding in Anticoagulated Patients
  • Gastrointestinal Hemorrhage

Interventions

DRUG

Warfarin

DRUG

LMW Heparin

Sponsors & Collaborators

  • Rambam Health Care Campus

    collaborator OTHER

  • Carmel Medical Center

    collaborator OTHER

  • Soroka University Medical Center

    collaborator OTHER

  • Tel Aviv Medical Center

    collaborator OTHER

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-05-31
Completion
2017-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02375646 on ClinicalTrials.gov