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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
October 8, 2013
October 10, 2013
March 17, 2017
April 28, 2017
May 30, 2017
January 2012
May 2013   (Final data collection date for primary outcome measure)
  • 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.
Perioperative Bleeding Complications [ Time Frame: up to 90 days post op ]
Development of perioperative bleeding complications, including need for blood transfusions, hematoma, and bleeding requiring re-admission or re-operation
Complete list of historical versions of study NCT01960296 on ClinicalTrials.gov Archive Site
  • 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 ]
Development of Myocardial Infarction or Thrombosis [ Time Frame: up to 90 days ]
Not Provided
Not Provided
 
Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Clopidogrel
  • Drug: Clopidogrel
    Continue home dose of clopidogrel into surgery
  • Drug: Discontinue Clopidogrel
    Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
  • Experimental: Clopidogrel
    Continue home dose of clopidogrel into surgery
    Intervention: Drug: Clopidogrel
  • Active Comparator: Discontinue
    Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
    Intervention: Drug: Discontinue Clopidogrel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01960296
GCO 10-1067
Yes
Not Provided
Not Provided
Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
Doris Duke Charitable Foundation
Principal Investigator: Celia M Divino, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP