Indomethacin and Cardiac Bypass Surgery

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073670
• Other study ID #: ANAE-062-00
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2010
• Last updated: February 22, 2010
• Start date: August 2000
• Est. completion date: April 2002

Study information

• Verified date: February 2010
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hemorrhage

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of blood lost via chest drains during and following cardiac bypass surgery		during surgery and then until chest drains removed (< 24 hours)	Yes
Secondary	blood clotting indices (i.e., conventional and using thromboelastography)		perioperative period until 24 hours post-operative	Yes
Secondary	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	Yes
Secondary	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	Yes