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

The Effect of Standard vs Aggressive Dosing Regimens for Epsilon-aminocaproic Acid on a Quantifiable Parameter of Fibrinolysis as Measured by Thromboelastography

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01965730

Acronym

EACA

Enrollment

Registered

2013-10-18

Start date

2013-01-31

Completion date

2014-06-30

Last updated

2019-05-02

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

Conditions

Aortic Disease

Keywords

dilated ascending aorta

Brief summary

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

Interventions

DRUGepsilon-aminocaproic acid (EACA)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
degree of fibrinolysis as measured by thromboelastography	Length of cardiac surgery	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.

Countries

United States

Outcome results

None listed

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