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NCT02037373 · ClinicalTrials.gov registry record
Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation
A clinical trial, sponsored by Octapharma.
- Terminated
- Registry status
- 43
- Enrollment target
NCT02037373: Clinical Trial study, sponsored by Octapharma.
NCT02037373 is a clinical trial that was terminated before completion, run by Octapharma. The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02037373 was terminated before completion, sponsored by Octapharma.
- TERMINATED
- Registry status
- 43 participants
- Enrollment target
Study Summary
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).
Primary Outcome
The incidence of 'clinically relevant hyperfibrinolytic events' in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma. For this trial a 'clinically relevant hyperfibrinolytic event' is defined as a decrease of at least 7.5% in the maximum amplitude (MA) as measured by the thromboelastography (TEG) or rotational thromboelastography (ROTEM) within 30 minutes after MA is achieved and the event is associated with bleeding requiring intervention.
Interventions
- BIOLOGICAL Octaplas™
- BIOLOGICAL Plasma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-08 |
| Est. Completion | 2018-02 |
Why NCT02037373 stopped before completion
NCT02037373 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Octaplas™ is the first listed.
NCT02037373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02037373 about?
NCT02037373 is a clinical study titled "Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation". Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh ...
What is the current status of trial NCT02037373?
This trial is currently terminated. The enrollment target is 43 participants. The study started on 2015-08. Estimated completion is 2018-02.
What interventions are being tested in trial NCT02037373?
The interventions under investigation include: Octaplas™ (BIOLOGICAL), Plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT02037373?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
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