Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?

NCT ID: NCT01960296

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-05-31

Brief Summary

Patients who on taking clopidogrel are randomized to either continue clopidogrel into general surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel after surgery. The investigators track the development of bleeding complications that may develop within 90 days of the surgery. Patients are medically cleared to be in either arm of the study by their cardiologist and surgeon. There is currently no evidence to support for or against the use continuation or discontinuation of clopidogrel prior to general surgery.

Detailed Description

A medical record review was performed of 104 consecutive patients undergoing general surgical procedures while receiving antiplatelet therapy. Patients were identified from an administrative database by crossreferencing clopidogrel with abdominal operative procedures. The records of only patients who were actively receiving antiplatelet therapy, with the last clopidogrel dose within 45 days of their operation, were considered in the study.

Conditions

Clopidogrel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Clopidogrel

Continue home dose of clopidogrel into surgery

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

Continue home dose of clopidogrel into surgery

Discontinue

Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Group Type: ACTIVE_COMPARATOR

Discontinue Clopidogrel

Intervention Type: DRUG

Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Interventions

Clopidogrel

Continue home dose of clopidogrel into surgery

Intervention Type: DRUG

Discontinue Clopidogrel

Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• taking clopidogrel
• undergoing general surgery
• cleared by both cardiologist and surgery for randomized arm

Exclusion Criteria

• previous history of bleeding complications/bleeding disposition
• no capacity to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celia M Divino, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

Chernoguz A, Telem DA, Chu E, Ozao-Choy J, Tammaro Y, Divino CM. Cessation of clopidogrel before major abdominal procedures. Arch Surg. 2011 Mar;146(3):334-9. doi: 10.1001/archsurg.2011.23.

Reference Type: BACKGROUND

PMID: 21422366 (View on PubMed)

Chu EW, Chernoguz A, Divino CM. The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial. Am J Surg. 2016 Jun;211(6):1019-25. doi: 10.1016/j.amjsurg.2015.05.036. Epub 2015 Aug 20.

Reference Type: RESULT

PMID: 27002953 (View on PubMed)

Other Identifiers

GCO 10-1067

Identifier Type: -

Identifier Source: org_study_id