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Postpolypectomy Bleeding in Patients With Antiplatelet Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Soonchunhyang University Hospital
Sponsor:
Information provided by (Responsible Party):
Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01465256
First received: November 1, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Bleeding Complication During Colon Polypectomy
Drug: Aspirin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Official Title: Postpolypectomy Bleeding in Patients Undergoing Colonoscopy on Antiplatelet Therapy. - Multicenter, Prospective Observational Study -

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • postpolypectomy bleeding rate [ Time Frame: bleeding after polypectomy within 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465256

Locations
Korea, Republic of
Soonchunhyang univerisity hospital Recruiting
Seoul, Korea, Republic of, 140-743
Contact: Hyun Gun Kim, MD., PhD.       medgun@schmc.ac.kr   
Principal Investigator: Hyun Gun Kim, MD., PhD.         
Sponsors and Collaborators
Soonchunhyang University Hospital
  More Information

No publications provided

Responsible Party: Hyun Gun, Kim. M.D., Ph.D., Assistant professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01465256     History of Changes
Other Study ID Numbers: KASIDPOLYP
Study First Received: November 1, 2011
Last Updated: March 25, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Soonchunhyang University Hospital:
Aspirin
Colon polypectomy
Bleeding

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014