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NCT01428102 · ClinicalTrials.gov registry record
RapidTEG MA Validation
A clinical trial, sponsored by Haemonetics Corporation.
- Terminated
- Registry status
- 17
- Enrollment target
NCT01428102: Clinical Trial study, sponsored by Haemonetics Corporation.
NCT01428102 is a clinical trial that was terminated before completion, run by Haemonetics Corporation. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01428102 was terminated before completion, sponsored by Haemonetics Corporation.
- TERMINATED
- Registry status
- 17 participants
- Enrollment target
Study Summary
During normal physiological conditions hemostasis (the ability of blood to clot) is kept in homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex series of steps on both sides of the coagulation cascade including cellular components (i.e. clot formation and breakdown). However, should this homeostatic balance be upset, normal hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding (hemorrhage). In instances that include acquired or congenital abnormalities of the hemostatic system it is clinically important to diagnose, monitor and manage the patient to optimize therapeutic intervention. Moreover, it is important to regulate the hemostasis system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain the homeostatic balance. The TEG® analyzer, using a small whole blood sample, documents the interaction of platelets with the protein coagulation cascade from the time of placing the blood in the analyzer until initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via GPIIb/IIIa, through eventual clot lysis. It displays both qualitatively and quantitatively the two distinct parts of hemostasis - the part that produces the clot and the part that causes the breakdown of the clot. It shows the balance or degree of imbalance in the patient's hemostasis system, highlights any areas of deficiency or excess, and offers a precise view of the patient's hemostasis condition. If the system is not in balance, one can see where the imbalance lies. If a patient is bleeding, it is crucial to determine the cause of bleeding as soon as possible in order to start the proper treatment. By utilizing a kaolin/tissue factor activator (RapidTEG™), the TEG® system can measure the interaction and simultaneous contribution of the intrinsic and extrinsic coagulation pathways which initiate and result in clot formation. This RapidTEG™ reagent can deliver results faster than ac
Primary Outcome
TEG paramaters were to be correlated in samples run concurrently using Kaolin and RapidTEG assays.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-10 |
Why NCT01428102 stopped before completion
NCT01428102 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01428102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01428102 about?
NCT01428102 is a clinical study titled "RapidTEG MA Validation". During normal physiological conditions hemostasis (the ability of blood to clot) is kept in homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex series of steps on both sides of the coagulation cascade including cellular components (i.e. clot formation and breakd...
What is the current status of trial NCT01428102?
This trial is currently terminated. The enrollment target is 17 participants. The study started on 2011-07. Estimated completion is 2012-10.
Who is sponsoring clinical trial NCT01428102?
This trial is sponsored by Haemonetics Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
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