NCT01965730

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

October 16, 2013

Last Update Submit

April 30, 2019

Conditions

Aortic Disease

Keywords

dilated ascending aorta

Outcome Measures

Primary Outcomes (1)

  • 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.

    Length of cardiac surgery

Study Arms (2)

epsilon-aminocaproic acid (EACA)

ACTIVE COMPARATOR

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

Drug: epsilon-aminocaproic acid (EACA)

EACA

EXPERIMENTAL

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

Drug: epsilon-aminocaproic acid (EACA)

Interventions

epsilon-aminocaproic acid (EACA)DRUG
Also known as: Amicar
EACAepsilon-aminocaproic acid (EACA)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Aortic Diseases

Interventions

Aminocaproic Acid

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AminocaproatesCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Prakash A Patel, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 18, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

US(1)