CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
RiaSTAPdrug
Likely dose
RiaSTAP 70 mg/kgfrom 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/NCT01300286
NCT01300286Phase 4Completed
CompareCT.gov

Open Label Use Of RiaStap During Aortic Reconstruction

Duke University·interventional·Posted Feb 21, 2011·Updated Dec 25, 2014

In Brief

A Phase 4 clinical trial evaluating RiaSTAP for Coagulopathic Bleeding. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoagulopathic Bleeding
CountriesUnited States
CollaboratorsCSL Behring

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2011
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.4 years ago

Interventions

RiaSTAPdrug

One time dose of 70 mg/kg will be administered intravenously.