Recruitment

Recruitment Status
Completed

Inclusion Criterias

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

Exclusion Criterias

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

Summary

Conditions
Pathologic Fibrinolysis
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 Epsilonaminocaproi...

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.

Inclusion Criterias

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

Exclusion Criterias

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

Locations

Stanford, California, 94305
Stanford, California, 94305

Tracking Information

NCT #
NCT01981863
Collaborators
Not Provided
Investigators
  • Principal Investigator: Pieter JA Van der Starre, MD, PhD Stanford University
  • Pieter JA Van der Starre, MD, PhD Stanford University