NCT01073670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

1.7 years

First QC Date

February 19, 2010

Last Update Submit

February 22, 2010

Conditions

Hemorrhage

Keywords

NSAIDsbleedingthromboelastographycardiac surgeryIndomethacinacetaminophen

Outcome Measures

Primary Outcomes (1)

  • amount of blood lost via chest drains during and following cardiac bypass surgery

    during surgery and then until chest drains removed (< 24 hours)

Secondary Outcomes (3)

  • 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

  • pain scores

    perioperative period until 24 hours post-operative

Study Arms (3)

Acetaminophen

ACTIVE COMPARATOR

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

Indomethacin

EXPERIMENTAL

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

Combination

EXPERIMENTAL

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

Interventions

IndomethacinDRUG

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.

Also known as: Indocin
Indomethacin
Acetaminophen & IndomethacinDRUG

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.

Also known as: Tylenol, Indocin
Combination
AcetaminophenDRUG

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.

Also known as: Tylenol
Acetaminophen

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

IndomethacinAcetaminophen

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Joel L Parlow, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 23, 2010

Study Start

August 1, 2000

Primary Completion

April 1, 2002

Study Completion

April 1, 2002

Last Updated

February 23, 2010

Record last verified: 2010-02

Locations

CA(1)