Indomethacin and Cardiac Bypass Surgery

Queen's University

Status and phase: Completed; Phase 4

Conditions: Hemorrhage

Treatments: Drug: Acetaminophen & Indomethacin; Drug: Acetaminophen; Drug: Indomethacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01073670

ANAE-062-00

Details and patient eligibility

About

Following signed informed consent, patients scheduled for elective cardiac surgery were randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination of both immediately following induction and then at 6, 12, 18 & 24 hours following surgery. Our primary outcome measure was the amount of blood drained from the mediastinal tubes and chest drains. Secondary outcome measures included conventional blood coagulation indices as well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary outcome measures included consumption of morphine equivalents and pain scores.

Enrollment: 82 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled to undergo either elective coronary artery bypass or single valve replacement
• normal platelet count
• normal prothrombin time
• normal partial thromboplastin time
• normal serum creatinine

Exclusion criteria

• sensitivity to study drugs
• history of bleeding diathesis
• renal dysfunction
• active peptic ulcer

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 3 patient groups

Acetaminophen

Active Comparator group

Description:

Participants received a loading dose of acetaminophen (2600 mg) at induction followed by 1300 mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.

Treatment:

Drug: Acetaminophen

Indomethacin

Experimental group

Description:

Participants were given 100 mg of indomethacin at induction and then 50 mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.

Treatment:

Drug: Indomethacin

Combination

Experimental group

Description:

Participants were given a loading dose of 1300 mg of acetaminophen and 50 mg of Indomethacin followed by 650mg of acetaminophen and 25 mg of indomethacin at 6, 12, 18 and 24 hours following cardiac bypass surgery.

Treatment:

Drug: Acetaminophen & Indomethacin