CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Not specified
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/NCT00146653
NCT00146653N/ACompleted

A Comparison of Heparin Management Strategies in Children Undergoing Cardiopulmonary Bypass.

Emory University·observational·Posted Sep 7, 2005·Updated Nov 20, 2013

In Brief

An observational study for Primary Condition: Heart Defects Requiring Surgery With CPB. Completed, enrolled 20 participants across 1 site.

Detailed Summary

We propose a comparison between between our standard ACT based heparin management protocol for children undergoing CPB and a patient-specific heparin concentration-based heparin management protocol. We hypothesize that a heparin concentration-based anticoagulation management protocol during CPB in children will result in more effective attenuation of hemostatic activation as reflected by decreased levels of thrombin formation and, ultimately, better preservation of hemostasis postoperatively. An additional 20 patients will be enrolled to address the validation of heparin concentrations calculated by the Hepcon machine with laboratory-measured heparin concentrations. These patients will not be randomized and therefore will not receive an intervention.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2005
Enrollment StartDec 1, 2005
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago