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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01960296
First Posted: October 10, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  Purpose
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.

Condition Intervention Phase
Clopidogrel Drug: Clopidogrel Drug: Discontinue Clopidogrel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Bleeding-related Re-hospitalization [ Time Frame: up to 90 days post op ]
    Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.

  • 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 Outcome Measures:
  • Procedure Estimated Blood Loss [ Time Frame: up to 90 days postop ]
  • Procedure Time [ Time Frame: Day 1 ]
  • Average Change in Hematocrit [ Time Frame: baseline and Day 1 ]
    hematocrit levels change from preoperative to postoperative

  • Average Length of Hospital Stay [ Time Frame: up to 90 days ]
  • Same Day Discharged [ Time Frame: up to 90 days ]
    Number of patients discharged on the day of surgery

  • Development of Myocardial Infarction or Thrombosis [ Time Frame: up to 90 days ]

Enrollment: 48
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960296


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Celia M Divino, MD Icahn School of Medicine at Mount Sinai
  More Information

Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01960296     History of Changes
Other Study ID Numbers: GCO 10-1067
First Submitted: October 8, 2013
First Posted: October 10, 2013
Results First Submitted: March 17, 2017
Results First Posted: April 28, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by Icahn School of Medicine at Mount Sinai:
clopidogrel
general surgery

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors