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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Clopidogrel

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Discontinue Clopidogrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel<br>Continue home dose of clopidogrel into surgery | Drug: Clopidogrel<br>* Continue home dose of clopidogrel into surgery<br>|
| Active Comparator: Discontinue<br>Discontinue home dose of clopidogrel one week before surgery. Resume after surgery. | Drug: Discontinue Clopidogrel<br>* Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding-related Re-hospitalization | Perioperative Bleeding Complications as indicated by bleeding requiring re-admission. | up to 90 days post op | 
| Perioperative Bleeding Complications | 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 |  | up to 90 days postop | 
| Procedure Time |  | Day 1 | 
| Average Change in Hematocrit | hematocrit levels change from preoperative to postoperative | baseline and Day 1 | 
| Average Length of Hospital Stay |  | up to 90 days | 
| Same Day Discharged | Number of patients discharged on the day of surgery | up to 90 days | 
| Development of Myocardial Infarction or Thrombosis |  | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clopidogrel, general surgery