Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01283321 · ClinicalTrials.gov registry record · Phase 2
RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01283321 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 26 participants.
The verdict
NCT01283321, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet transfusion has been the primary therapy to treat bleeding after this type of procedure. More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The objective of this trial is to demonstrate the clinical equivalency and economic utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in patients in lieu of platelet transfusion. Purified fibrinogen concentrate has been approved by FDA, and it has been used for the treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated with volume overload, bacterial/viral infection, immunological effects and excess blood clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare. Although platelet transfusion is widely used after heart surgery, there has been no randomized study to endorse this practice. In this study, patients undergoing heart valve replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if there is evidence of significant microvascular bleeding. Fifteen minutes after the initial treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be treated with blood transfusion per institutional sta
Interventions
- DRUG Human fibrinogen concentrate
- OTHER apheresis platelets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01283321
The ClinicalTrials.gov registry entry for NCT01283321 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Human fibrinogen concentrate is the first listed.
NCT01283321 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01283321 about?
NCT01283321 is a clinical study titled "RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery". Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet transfusion has been the primary therapy to treat bleeding after this type of procedure. More recently, perioperative sup...
What is the current status of trial NCT01283321?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2011-01. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01283321?
The interventions under investigation include: Human fibrinogen concentrate (DRUG), apheresis platelets (OTHER).
Who is sponsoring clinical trial NCT01283321?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.