Postpolypectomy Bleeding in Patients With Antiplatelet Therapy

NCT01465256 | Unknown DMC

• 1 other identifier: KASIDPOLYP
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bleeding Complication During Colon Polypectomy

Keywords

Aspirin; Colon polypectomy; Bleeding

Outcome Measures

Primary Outcomes (1)

• postpolypectomy bleeding rate

  bleeding after polypectomy within 30 days

Study Arms (2)

Aspirin holding group

NO INTERVENTION

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

Aspirin continuing group

EXPERIMENTAL

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

Interventions

Aspirin DRUG

Aspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease,

Aspirin continuing group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang univerisity hospital

Seoul, Seoul, 140-743, South Korea

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 4, 2011
• Study Start: April 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

KR (1)