Fibrinolysis Before Cardiopulmonary Bypass?

Phase 4

Completed

• Conditions: Pathologic Fibrinolysis
• Interventions: Drug: Epsilonaminocaproic acid; Drug: Placebo

• Registration Number: NCT01981863
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-04
• Results First Submitted: 2016-04-01
• Results First Submitted QC: 2016-05-23
• Last Update Submitted: 2016-05-23
• Results First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

• Resternotomy, renal insufficiency, deep hypothermia, age < 18 yrs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epsilonaminocaproic acid	Epsilonaminocaproic acid	One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Placebo, Antifibrinolytic activity	Placebo	Placebo: same IV volume as experimental arm

Primary Outcome Measures

Name	Time	Method
Di-Dimer Increase Before Cardiopulmonary Bypass	6 months	Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.

Secondary Outcome Measures

Name	Time	Method
Value of Thromboelastography as Monitor of Fibrinolysis	6 months	Thromboelastography may display if fibrinolysis is present

Trial Locations

Locations (1)

Stanford Hospital & Clinics; 🇺🇸 Stanford, California, United States