Phase 4
N=40
Fibrinolysis Before Cardiopulmonary Bypass?
Pathologic Fibrinolysis
Bottom Line
View on ClinicalTrials.gov: NCT01981863 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Di-Dimer Increase Before Cardiopulmonary Bypass — 317; 266; 317; 291 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Epsilonaminocaproic acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Di-Dimer Increase Before Cardiopulmonary Bypass |
317; 266; 317; 291; 537; 911 | — |
| SECONDARY Value of Thromboelastography as Monitor of Fibrinolysis |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01981863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.