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

NCT ID: NCT01965730

Last Updated: 2019-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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Conditions

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Aortic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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epsilon-aminocaproic acid (EACA)

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

Group Type ACTIVE_COMPARATOR

epsilon-aminocaproic acid (EACA)

Intervention Type DRUG

EACA

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

Group Type EXPERIMENTAL

epsilon-aminocaproic acid (EACA)

Intervention Type DRUG

Interventions

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epsilon-aminocaproic acid (EACA)

Intervention Type DRUG

Other Intervention Names

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Amicar

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prakash A Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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816724

Identifier Type: -

Identifier Source: org_study_id

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