Fibrinolysis Before Cardiopulmonary Bypass?

Study Overview
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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.

Official Title
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Fibrinolysis Before Cardiopulmonary Bypass?

Conditions
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Pathologic Fibrinolysis

Intervention / Treatment
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* Drug: Epsilonaminocaproic acid
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epsilonaminocaproic acid<br>One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo | Drug: Epsilonaminocaproic acid<br>* One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.<br>* Other names: Amicar;|
| Placebo Comparator: Placebo, Antifibrinolytic activity<br>Placebo: same IV volume as experimental arm | Drug: Placebo<br>* Placebo administered in same volume as in experimental arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Di-Dimer Increase Before Cardiopulmonary Bypass | Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of Thromboelastography as Monitor of Fibrinolysis | Thromboelastography may display if fibrinolysis is present | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, cardiopulmonary bypass, fibrinolysis, thromboelastography, D-Dimers, antifibrinolytic agents