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Indomethacin and Cardiac Bypass Surgery

Primary Purpose

Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Indomethacin
Acetaminophen & Indomethacin
Acetaminophen
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemorrhage focused on measuring NSAIDs, bleeding, thromboelastography, cardiac surgery, Indomethacin, acetaminophen

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Acetaminophen

Indomethacin

Combination

Arm 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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blood clotting indices (i.e., conventional and using thromboelastography)
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.
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.

Full Information

First Posted
February 19, 2010
Last Updated
February 22, 2010
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT01073670
Brief Title
Indomethacin and Cardiac Bypass Surgery
Official Title
Quantification of Postoperative Coagulation Following Administration of Indomethacin to Expedite Fast-tracking of Cardiac Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
April 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
NSAIDs, bleeding, thromboelastography, cardiac surgery, Indomethacin, acetaminophen

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm 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.
Arm Title
Indomethacin
Arm Type
Experimental
Arm 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.
Arm Title
Combination
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Other Intervention Name(s)
Indocin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen & Indomethacin
Other Intervention Name(s)
Tylenol, Indocin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
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.
Primary Outcome Measure Information:
Title
amount of blood lost via chest drains during and following cardiac bypass surgery
Time Frame
during surgery and then until chest drains removed (< 24 hours)
Secondary Outcome Measure Information:
Title
blood clotting indices (i.e., conventional and using thromboelastography)
Time Frame
perioperative period until 24 hours post-operative
Title
Morphine equivalents required to provide effective analgesia
Description
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.
Time Frame
perioperative period until 24 hours post-operative
Title
pain scores
Description
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.
Time Frame
perioperative period until 24 hours post-operative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel L Parlow, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

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Indomethacin and Cardiac Bypass Surgery

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