Indomethacin and Cardiac Bypass Surgery

Quantification of Postoperative Coagulation Following Administration of Indomethacin to Expedite Fast-tracking of Cardiac Surgical Patients

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Drug: Acetaminophen; Drug: Indomethacin; Drug: Acetaminophen & Indomethacin

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Acetaminophen; 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.	Drug: Acetaminophen; Subjects were given a loading dose of 2600 mg of acetaminophen (via suppository) at time of induction for anesthesia then given 1300mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.; Other Names: Tylenol
EXPERIMENTAL: Indomethacin; Participants were given 100 mg of indomethacin at induction and then 50 mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.	Drug: Indomethacin; Indomethacin was given via suppository at time of induction for anesthesia (2 x 50 mg) followed by one 50 mg suppository at 6, 12, 18 and 24 hours following cardiac bypass surgery.; Other Names: Indocin
EXPERIMENTAL: Combination; 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.	Drug: Acetaminophen & Indomethacin; Subjects were given a loading dose of acetaminophen (1300 mg) and indomethacin (50 mg)by suppository at the time of induction for anesthesia and then given 650mg acetaminophen + 25 mg indomethacin at 6, 12, 18 and 24 hours following cardiac bypass surgery.; Other Names: Tylenol; Indocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
amount of blood lost via chest drains during and following cardiac bypass surgery	during surgery and then until chest drains removed (< 24 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood clotting indices (i.e., conventional and using thromboelastography)		perioperative period until 24 hours post-operative
Morphine equivalents required to provide effective analgesia	The milligram quantities of morphine or the equivalents of morphine administered (in addition to the acetaminophen, indomethacin or combination therapy) were recorded and compared between groups. This provided an indication of how effective each of our interventions were at providing pain relief.	perioperative period until 24 hours post-operative
pain scores	Resting pain scores were recorded for all subjects at 6, 12 18 and 24 hours following surgery and compared between groups. These scores provided an indication as to the efficacy of each of our interventions at providing pain relief.	perioperative period until 24 hours post-operative

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Joel L Parlow, MD, Queen's University

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (ACTUAL): April 1, 2002
• Study Completion (ACTUAL): April 1, 2002

Study Registration Dates

• First Submitted: February 19, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (ESTIMATE): February 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 23, 2010
• Last Update Submitted That Met QC Criteria: February 22, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: cardiac surgery; bleeding; acetaminophen; Indomethacin; NSAIDs; thromboelastography
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Acetaminophen; Indomethacin
• Other Study ID Numbers: ANAE-062-00