NCT01960296

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

Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Clopidogrel	Continue home dose of clopidogrel into surgery
DRUG	Discontinue Clopidogrel	Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-10-10
• Last updated: 2017-05-30
• Results posted: 2017-04-28

Locations

1 site across 1 country: United States