At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
RiaStAP +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.
The Role of Human Fibrinogen Concentrate (RiaSTAP) in Decreasing Blood Loss and the Need for Component Blood Therapy in Infants Undergoing Cardiopulmonary Bypass.
Nicklaus Children's Hospital f/k/a Miami Children's Hospital·interventional·Posted Jul 4, 2016·Updated Sep 16, 2021
In Brief
A Phase 4 clinical trial evaluating RiaStAP and Saline for Hypofibrinogenemia and 2 related conditions. Completed, enrolled 30 participants across 2 sites.
Detailed Summary
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypofibrinogenemia, Afibrinogenemia, Bleeding Disorders
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartJun 2017
Primary CompletionAug 2019
Study CompletionDec 2020
TodayJul 2026
First PostedJul 4, 2016
Enrollment StartJun 1, 2017
Primary CompletionAug 26, 2019
Study CompletionDec 24, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.0 years ago
Interventions
RiaStAPdrug
To decrease post-operative bleeding volume.
Salinedrug
Placebo consisting of normal saline 0.9%