Postpolypectomy Bleeding in Patients With Antiplatelet Therapy

March 25, 2014 updated by: Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital

Postpolypectomy Bleeding in Patients Undergoing Colonoscopy on Antiplatelet Therapy. - Multicenter, Prospective Observational Study -

The purpose of this study is to determine if the use of aspirin prior to colonoscopy increases the risk of post polypectomy bleeding. The primary end point is comparison of bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit group. The secondary end point is analysis of risk factors which affect early or delayed post polypectomy bleeding.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Based on very limited evidences, ASGE recommended that endoscopic procedures may be performed on patients taking aspirin. However in a survey of ASGE members regarding their endoscopic practice, 81% would consider discontinuation of aspirin before colonoscopy and 66% would not perform snare polypectomy if patients had not discontinued aspirin. Although a large prospective randomized control trial would be the ideal way to address this issue theoretically, the investigators hypothesized that there are no differences of the post polypectomy bleeding rate in patients whether continuous taking aspirin prior to polypectomy or not.

In this study, we classified the patients into two groups; the patients who can stop taking aspirin before colon polypectomy will be enrolled into group 1, and the patients who take both thienopyridines and aspirin for their underlying disease and should keep take aspirin during colon polypectomy will be enrolled into group 2. The patients of group 1 stop taking aspirin 7 days before polypectomy.

thromboembolism. Exclusions are as follow; patients taking anti-thrombotic agents, patients have low a platelet count (<80,000/mm3) and/or prolongated PT/aPTT, patients who have chronic renal disease (creatinine>3mg/dl over 6 months), patients who have GI malignancies, patients who are over ASA classification class III, over 2 score of HAS-BLED and over 1 of CHAD2 score. The expected enrolled patients number is 500 patients (250 in each group).

All cases of polypectomy are performed with identical methodology; resection after epinephrine mixture injection under blended or mixed current wave. The data includes the patients information such as sex, age, body weight, BMI and vascular disease history such as hypertension, diabetes, ischemic heart disease, cerebrovascular disease, COPD, modified HAS-BLED score and CHADS2 score. The data of polyp related factor include number of polyps, bleeding status(acute, early, delayed/minimal, moderate, sever), endoscopist (staff or fellow), bowel preparation status, polyp character (shape, location, pathology) and procedures for bleeding (clipping, APC, epinephrine injection, band ligation etc.).

All procedure will be performed with the endoscopist blinded to the patient status of whether the patient is taking aspirin continuously or not.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 140-743
        • Recruiting
        • Soonchunhyang univerisity hospital
        • Contact:
        • Principal Investigator:
          • Hyun Gun Kim, MD., PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients who take low dose aspirin (75~160mg) for primary prevention of vascular disease and low risk for thromboembolism.

Exclusion Criteria:

  • The patients who taking anti-thrombotic agents,
  • The patients who taking thienopyridines or other NSAID with aspirin,
  • The patients who have low platelet count(<80,000/mm3) and prolongated PT/aPTT in laboratory test,
  • The patients who have chronic renal disease (creatinine>3mg/dl over 6 months),
  • The patients who have polyps over than 1 cm in size or thick pedicle over 1 cm,
  • The patients who have GI malignancies,the patients who are over ASA classification class III.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Aspirin holding group
Aspirin holding group (group 1): the patients enrolled into group 1 can stop taking aspirin during colon polypectomy. The patients are usually taking aspirin for primary prevention of vascular disease and have no risk of thromboembolism despite of they stop taking aspirin temporary
Experimental: Aspirin continuing group
Aspirin continuing group (group 2): the patients enrolled into group 2 should take aspirin during colon polypectomy because these patients are usually take thienopyridines and aspirin, and if they would stop taking aspirin during colon polypectomy, they have a thromboembolism risk.
Drug: Aspirin
Aspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postpolypectomy bleeding rate
Time Frame: bleeding after polypectomy within 30 days
bleeding after polypectomy within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KASIDPOLYP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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