Indomethacin and Cardiac Bypass Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01073670

Enrollment

Registered

2010-02-23

Start date

2000-08-31

Completion date

2002-04-30

Last updated

2010-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

Keywords

NSAIDs, bleeding, thromboelastography, cardiac surgery, Indomethacin, acetaminophen

Brief 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.

Interventions

DRUGIndomethacin

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.

DRUGAcetaminophen & 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.

DRUGAcetaminophen

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Measure	Time frame	Description
blood clotting indices (i.e., conventional and using thromboelastography)	perioperative period until 24 hours post-operative	—
Morphine equivalents required to provide effective analgesia	perioperative period until 24 hours post-operative	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.
pain scores	perioperative period until 24 hours post-operative	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026