Clinical trial NCT01960296: Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?
Official title: Evaluation of Clopidogrel Use in Peri-Operative General Surgery Patients: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clopidogrel
Keywords: clopidogrel
general surgery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2013-10-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Bleeding-related Re-hospitalization
timeFrame: up to 90 days post op
measure: Perioperative Bleeding Complications
timeFrame: up to 90 days postop
Secondary outcomes:
measure: Procedure Estimated Blood Loss
timeFrame: up to 90 days postop
measure: Procedure Time
timeFrame: Day 1
measure: Average Change in Hematocrit
timeFrame: baseline and Day 1
measure: Average Length of Hospital Stay
timeFrame: up to 90 days
measure: Same Day Discharged
timeFrame: up to 90 days
measure: Development of Myocardial Infarction or Thrombosis
timeFrame: up to 90 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Celia M Divino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chernoguz A, Telem DA, Chu E, Ozao-Choy J, Tammaro Y, Divino CM. Cessation of clopidogrel before major abdominal procedures. Arch Surg. 2011 Mar;146(3):334-9. doi: 10.1001/archsurg.2011.23.
citation: Chu EW, Chernoguz A, Divino CM. The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial. Am J Surg. 2016 Jun;211(6):1019-25. doi: 10.1016/j.amjsurg.2015.05.036. Epub 2015 Aug 20.