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

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ClinicalTrials.gov Identifier: NCT01960296
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : April 28, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Clopidogrel Drug: Clopidogrel Drug: Discontinue Clopidogrel Phase 2

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  (Clinical Trial)
Actual Enrollment : 48 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Publications of Results:
Other 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 Posted: October 10, 2013    Key Record Dates
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