Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02375646
Recruitment Status : Unknown
Verified February 2015 by Eran Israeli, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2015
Last Update Posted : March 2, 2015
Sponsor:
Collaborators:
Rambam Health Care Campus
Carmel Medical Center
Soroka University Medical Center
Tel Aviv Medical Center
Information provided by (Responsible Party):
Eran Israeli, Hadassah Medical Organization

Brief 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).


Condition or disease Intervention/treatment Phase
Post Polypectomy Bleeding in Anticoagulated Patients Gastrointestinal Hemorrhage Drug: Warfarin Drug: LMW Heparin Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients: a Prospective Single-blinded Multicenter Study Comparing Warfarin vs. Low Molecular Weight Heparin Based Bridging Anticoagulation
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continued Warfarin
continuous Warfarin therapy (aiming for therapeutic INR: 2-3) will be given throughout the study
Drug: Warfarin
Other Name: Coumadin

Active Comparator: LMW Heparin
Enoxaparin 1mg/kg SC bid (adjusted to renal function) will be given 5 days before the colonoscopy while withholding therapy with Warfarin. The day after procedure Warfarin therapy will be added, and Enoxaparin stopped when therapeutic INR will be reached
Drug: LMW Heparin
Other Name: Enoxaparin, Clexan




Primary Outcome Measures :
  1. Post-polypectomy major bleeding rate [ Time Frame: 2 weeks ]
    Delayed major GI-bleeding


Secondary Outcome Measures :
  1. immediate post-polypectomy bleeding [ Time Frame: up to 6 hours ]
    GI bleeding up to 6 hours post polypectomy

  2. Post-polypectomy major bleeding rate [ Time Frame: 2 weeks ]
    Delayed minor GI-bleeding

  3. Thromboembolic events [ Time Frame: 30 days ]
    VTE, acute MI, CVA



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375646


Contacts
Layout table for location contacts
Contact: Eran Israeli, MD 97226776848 erani@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Sponsors and Collaborators
Hadassah Medical Organization
Rambam Health Care Campus
Carmel Medical Center
Soroka University Medical Center
Tel Aviv Medical Center

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Eran Israeli, Head, IBD Unit, Institute of Gastroenterology and Liver Diseases, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02375646     History of Changes
Other Study ID Numbers: 0446-14-HMO
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: March 2, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Heparin
Calcium heparin
Warfarin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action