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NCT05295693 · ClinicalTrials.gov registry record
Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 40
- Enrollment target
NCT05295693: Completed study, sponsored by Stanford University.
NCT05295693 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05295693 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB. The current testing device used at our institution is the "TEG 5000" (Haemonetics Corporation). The novel coagulation testing device "Quantra System" (Hemosonics) has favorable properties (result within 20 minutes) allowing for a quicker identification of the coagulation problem and hence faster administration of the correct coagulation products, potentially leading to better coagulation quality and possibly reducing the need of additional blood products. The aim of this prospective observational (non-interventional, investigational only) quality improvement study is to investigate if the Quantra is reliable and valid in predicting the coagulation status when compared with our standard-of-care device TEG 5000.
Primary Outcome
Correlation/Linear regression/normal\_vs\_abnormal of Quantra (FCS) with TEG (K time \& alpha angle)
Interventions
- DEVICE Correlation of the Quantra with the TEG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-10-13 |
| Est. Completion | 2023-05-25 |
What the finished NCT05295693 record still lists
NCT05295693 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Correlation of the Quantra with the TEG is the first listed.
NCT05295693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05295693 about?
NCT05295693 is a clinical study titled "Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study". Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB. The current testing device used at our institution is the "TEG 5000" (Haemonetics Corporation). The novel coagulation testing device "Quantra Sys...
What is the current status of trial NCT05295693?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2022-10-13. Estimated completion is 2023-05-25.
What interventions are being tested in trial NCT05295693?
The interventions under investigation include: Correlation of the Quantra with the TEG (DEVICE).
Who is sponsoring clinical trial NCT05295693?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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