- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02408029
Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of the study is to validate the CORA System by comparing the results of this test to that of the standard of care device called the TEG 5000 system. Both systems evaluate hemostasis, a highly complex and interactive process involving many protein and cellular elements, especially platelets, occurring in a series of interrelated phases, which results in either normal hemostasis or a tendency toward bleeding or clotting complications.
The study protocol specifies testing using multiple reagents which are similar for both the CORA and TG 5000 systems. Tests are run in duplicate on blood samples taken from patients undergoing treatment for injuries and trauma. Following the protocol defined in CLSI Standard EP09-A2, equivalence between the two systems will be demonstrated if the conclusions from the Standard Section 7, Interpreting Results and Comparing to Internal Performance Criteria, are found to be acceptable.
All blood samples drawn for this study will use venous blood. Only citrated or heparinized whole blood samples are used. All samples are tested twice (run in duplicate). Quality Control procedures are run on both instruments at a frequency specified by the manufacturers. Results obtained from this testing are not used to make treatment decisions.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Indiana
-
South Bend, Indiana, Forenede Stater, 46601
- Indiana School of Medicine South Bend Notre Dame Campus
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- University of Texas Health Science Center at Houston
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 18 years of age and older
- Complete patient history including age, race, gender and type of trauma should be documented
Exclusion Criteria:
- Patients under the age of 18
- Native whole blood will not be used in this study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Trauma Patients Group
Patients undergoing treatment for injuries and trauma.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Composite measure: Blood coagulation and hemostasis parameters R (min), C-ACT (min), K (min), Angle (degrees), MA (mm) and LY30 (%) parameters for both TEG 5000 and CORA systems
Tidsramme: 1 day, measured at time of trauma treatment; no follow-up
|
1 day, measured at time of trauma treatment; no follow-up
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Charles E Wade, Ph.D., The University of Texas Health Science Center, Houston
- Ledende efterforsker: Martin A Schreiber, M.D., Oregon Health and Science University
- Ledende efterforsker: Mark Walsh, M.D., Indiana School of Medicine, South Bend Notre Dame Campus
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 01-229
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