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

April 28, 2017 updated by: Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Clopidogrel
Continue home dose of clopidogrel into surgery
Drug: Clopidogrel
Continue home dose of clopidogrel into surgery
ACTIVE_COMPARATOR: Discontinue
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Drug: Discontinue Clopidogrel
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Doris Duke Charitable Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (ESTIMATE)

October 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 10-1067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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