CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Epsilonaminocaproic acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01981863
NCT01981863Phase 4Completed
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Fibrinolysis Before Cardiopulmonary Bypass?

Stanford University·interventional·Posted Nov 13, 2013·Updated Jun 30, 2016

In Brief

A Phase 4 clinical trial evaluating Epsilonaminocaproic acid and Placebo for Pathologic Fibrinolysis. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPathologic Fibrinolysis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartJul 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.6 years ago

Interventions

Epsilonaminocaproic aciddrug

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

Placebodrug

Placebo administered in same volume as in experimental arm.