Fibrinolysis Before Cardiopulmonary Bypass?

NCT ID: NCT01981863

Last Updated: 2016-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-02-28

Brief Summary

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It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects. The investigators want to show that there is no proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.

Detailed Description

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Double-blind, placebo controlled, prospective study in two groups of 20 patients. Control group (A) receives standard Epsilonaminocaproic acid treatment before cardiopulmonary bypass (10 gr loading dose, and 1 gr/hr infusion), and second group (B) receives placebo. Before start of Epsilonaminocaproic acid/placebo, D-Dimers and Thromboelastography are measured, repeated just before full heparinization. After heparinization group A receives placebo, and group B Epsilonaminocaproic acid.

Conditions

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Pathologic Fibrinolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Epsilonaminocaproic acid

One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo

Group Type EXPERIMENTAL

Epsilonaminocaproic acid

Intervention Type DRUG

One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

Placebo, Antifibrinolytic activity

Placebo: same IV volume as experimental arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered in same volume as in experimental arm.

Interventions

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Epsilonaminocaproic acid

One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.

Intervention Type DRUG

Placebo

Placebo administered in same volume as in experimental arm.

Intervention Type DRUG

Other Intervention Names

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Amicar

Eligibility Criteria

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Inclusion Criteria

* All adult patients, undergoing first time sternotomy for Coronary artery bypass grafting/Aortic valve replacement/aortic surgery

Exclusion Criteria

* Resternotomy, renal insufficiency, deep hypothermia, age \< 18 yrs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pieter JA Van der Starre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Hospital & Clinics

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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Fibrinolysis

Identifier Type: -

Identifier Source: org_study_id

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