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Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery (EACA)

Primary Purpose

Aortic Disease

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
epsilon-aminocaproic acid (EACA)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Disease focused on measuring dilated ascending aorta

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to sign informed consent
  • Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest

Exclusion Criteria:

  • Inability to sign informed consent
  • Baseline hypercoagulable condition as defined in medical record
  • Coronary disease with untreated lesions or recent coronary stent placement
  • Severe renal dysfunction (ESRD) as documented in medical record

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

epsilon-aminocaproic acid (EACA)

EACA

Arm Description

75mg/kg loading dose with infusion 15mg/kg/hr

125mg/kg loading dose of EACA followed by an infusion of EACA at 25mg/kg/hr for length of cardiac surgery.

Outcomes

Primary Outcome Measures

degree of fibrinolysis as measured by thromboelastography
The primary objective of the study will be to determine if a change in EACA dosing for cardiac surgery cases involving circulatory arrest actually leads to a quantifiable change in the degree of fibrinolysis as measured by TEG.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2013
Last Updated
April 30, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01965730
Brief Title
Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery
Acronym
EACA
Official Title
The Effect of Standard vs Aggressive Dosing Regimens for Epsilon-aminocaproic Acid on a Quantifiable Parameter of Fibrinolysis as Measured by Thromboelastography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
the study was suspended due to shortage of the study drug (amicar).
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study hopes to determine the optimal antifibrinolytic dosing to decrease bleeding and blood transfusion after cardiac surgery without increasing adverse events

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Disease
Keywords
dilated ascending aorta

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epsilon-aminocaproic acid (EACA)
Arm Type
Active Comparator
Arm Description
75mg/kg loading dose with infusion 15mg/kg/hr
Arm Title
EACA
Arm Type
Experimental
Arm Description
125mg/kg loading dose of EACA followed by an infusion of EACA at 25mg/kg/hr for length of cardiac surgery.
Intervention Type
Drug
Intervention Name(s)
epsilon-aminocaproic acid (EACA)
Other Intervention Name(s)
Amicar
Primary Outcome Measure Information:
Title
degree of fibrinolysis as measured by thromboelastography
Description
The primary objective of the study will be to determine if a change in EACA dosing for cardiac surgery cases involving circulatory arrest actually leads to a quantifiable change in the degree of fibrinolysis as measured by TEG.
Time Frame
Length of cardiac surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to sign informed consent Elective cardiac surgery patients undergoing primary surgery involving circulatory arrest Exclusion Criteria: Inability to sign informed consent Baseline hypercoagulable condition as defined in medical record Coronary disease with untreated lesions or recent coronary stent placement Severe renal dysfunction (ESRD) as documented in medical record
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prakash A Patel, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Dosing of Amicar and Measure of Fibrinolysis by TEG During Cardiac Surgery

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