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OpenTrials
Completed

NCT Number: NCT01960296

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

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.

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Key information

Conditions

Clopidogrel

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Continue home dose of clopidogrel into surgery

Discontinue Clopidogrel

Drug

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

Primary outcomes

  1. Bleeding-related Re-hospitalization

    Time frame: up to 90 days post op

    Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.

  2. 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.

Secondary outcomes

  1. Procedure Estimated Blood Loss

    Time frame: up to 90 days postop

  2. Procedure Time

    Time frame: Day 1

  3. Average Change in Hematocrit

    Time frame: baseline and Day 1

    hematocrit levels change from preoperative to postoperative

  4. Average Length of Hospital Stay

    Time frame: up to 90 days

  5. Same Day Discharged

    Time frame: up to 90 days

    Number of patients discharged on the day of surgery

  6. Development of Myocardial Infarction or Thrombosis

    Time frame: up to 90 days

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 10, 2013
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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