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

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Mount Sinai Health System

Status and phase

Completed
Phase 2

Conditions

Clopidogrel

Treatments

Drug: Clopidogrel
Drug: Discontinue Clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT01960296
GCO 10-1067

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Clopidogrel
Experimental group
Description:
Continue home dose of clopidogrel into surgery
Treatment:
Drug: Clopidogrel
Discontinue
Active Comparator group
Description:
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Treatment:
Drug: Discontinue Clopidogrel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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