RapidTEG MA Validation (R-TEG MA)

This study has been terminated.
(Terminiated for trial redesign)
Sponsor:
Information provided by (Responsible Party):
Haemonetics Corporation
ClinicalTrials.gov Identifier:
NCT01428102
First received: September 1, 2011
Last updated: September 13, 2013
Last verified: September 2013

September 1, 2011
September 13, 2013
July 2011
October 2012   (final data collection date for primary outcome measure)
Correelation of Kaolin to RapidTEG [ Time Frame: Concurrent sample tested <2hrs from blood draw ] [ Designated as safety issue: No ]
TEG paramaters were to be correlated in samples run concurrently using Kaolin and RapidTEG assays.
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Complete list of historical versions of study NCT01428102 on ClinicalTrials.gov Archive Site
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RapidTEG MA Validation
Validation of the RapidTEG™ MA Compared to Kaolin in Trauma and Cardiac Patients.

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 activating with Kaolin alone. This protocol will specifically assess one algorithm called MA. MA is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa that represents the ultimate strength of the fibrin clot. This represents platelet function.

The objective of the study is to demonstrate the substantial equivalence of MA RapidTEG vs. MA Kaolin.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Patient is either a Trauma patient OR is diagnosed with known cardiovascular disease.

  • Coagulation
  • Platelet Function
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  • RapidTEG
    Samples tested with TEG which are both citrated and non-citrated and are activated using the reagent RapidTEG.
  • Kaolin
    Samples tested with TEG which are both citrated and non-citrated and are activated using the reagent Kaolin.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient age > 18 years old
  • Patient is either a Trauma patient OR is diagnosed with known cardiovascular disease.
  • Samples must be tested within the recommended timeline (4-6 minutes for non-citrated and between 15 minutes and 2 hours for citrated)

Exclusion Criteria:

  • Patients who have been placed on anticoagulation prophylaxis for other conditions (not CPB/PCI related).
  • Patients who have established hemostasis system abnormalities (congenital or other).
  • Samples identified as affected by testing errors by lab staff.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01428102
TP-CLN-100267A
No
Haemonetics Corporation
Haemonetics Corporation
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Haemonetics Corporation
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP