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Completed

NCT Number: NCT01981863

Fibrinolysis Before Cardiopulmonary Bypass?

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.

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Key information

Conditions

Pathologic Fibrinolysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford Hospital & Clinics

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epsilonaminocaproic acid

Drug

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

Other names: Amicar

Placebo

Drug

Placebo administered in same volume as in experimental arm.

Primary outcomes

  1. Di-Dimer Increase Before Cardiopulmonary Bypass

    Time frame: 6 months

    Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.

Secondary outcomes

  1. Value of Thromboelastography as Monitor of Fibrinolysis

    Time frame: 6 months

    Thromboelastography may display if fibrinolysis is present

Other outcomes

  1. Length of Time Between Incision and Cardiopulmonary Bypass

    Time frame: From incision to bypass, up to 3 hours

    Mean Length of Time from Incision to Cardiopulmonary Bypass

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2013
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.