CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
recombinant human erythropoietin, rhEpo +1 moredrug
Likely dose
recombinant human erythropoietin, rhEpo 7 gfrom 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/NCT00313716
NCT00313716Phase 3Completed

Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury

Claudia Sue Robertson·interventional·Posted Apr 12, 2006·Updated Sep 10, 2014

In Brief

A Phase 3 clinical trial evaluating recombinant human erythropoietin, rhEpo and placebo for Anemia and Traumatic Brain Injury. Completed, enrolled 200 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 12, 2006
Enrollment StartApr 1, 2006
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 20.2 years ago

Interventions

recombinant human erythropoietin, rhEpodrug

The study design is 2x2 factorial with randomization to erythropoietin or placebo and to transfusion trigger 10 gm/dl or 7 g/dl. Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks (first 74 patients, Epo1 dosing regimen), and then the 24- and 48-hour doses were stopped for the remainder of the patients (remaining 126 patients, Epo2 dosing regimen).

placeboother

an inactive substance