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

Phase 2

Completed

• Conditions: Clopidogrel
• Interventions: Drug: Discontinue Clopidogrel; Drug: Clopidogrel

• Registration Number: NCT01960296
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Results First Submitted: 2017-03-17
• Results First Submitted QC: 2017-03-17
• Status Verified: 2017-04
• Results First Posted: 2017-04-28
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinue	Discontinue Clopidogrel	Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Clopidogrel	Clopidogrel	Continue home dose of clopidogrel into surgery

Primary Outcome Measures

Name	Time	Method
Perioperative Bleeding Complications	up to 90 days postop	Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.
Bleeding-related Re-hospitalization	up to 90 days post op	Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.

Secondary Outcome Measures

Name	Time	Method
Procedure Estimated Blood Loss	up to 90 days postop
Procedure Time	Day 1
Same Day Discharged	up to 90 days	Number of patients discharged on the day of surgery
Development of Myocardial Infarction or Thrombosis	up to 90 days
Average Change in Hematocrit	baseline and Day 1	hematocrit levels change from preoperative to postoperative
Average Length of Hospital Stay	up to 90 days

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States