Thromboelastography Normal Reference Values in China Hunan Province

Coagulopathy Clinical Trial

Official title:

Establishment for Thromboelastography Normal Reference Values of Healthy Adults in China Hunan Province: A Multicenter Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146455
• Other study ID #: ThirdXiangyaHCSU
• Status: Completed
• First received: May 7, 2017
• Last updated: March 24, 2018
• Start date: June 5, 2017
• Est. completion date: March 10, 2018

Study information

• Verified date: March 2018
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to establish the normal reference range of Thrombelastogram parameters in Hunan by a multicenter study, and to analyze the specificity of Thrombelastogram detection and the influence of gender, age and blood type on Thrombelastogram. The study will provide basic data and statistical basis for the establishment of normal reference range of Thrombelastogram in Hunan.

Description:

Thrombelastograghy (TEG) is an important test to assess the blood coagulation function to monitor the whole process of perioperative coagulation. TEG can evaluate the coagulation cascade, from platelet aggregation, clot strengthening and fibrin cross-linking to eventually clot lysis in small volume of whole blood. The reference range is one important element to influence the TEG results. At present, a number of studies have shown that reference range of TEG exists significant differences between different racial and geographic. At the same time, reagent manufacturers also suggested that each TEG laboratory should establish its own reference range. So it is important to establish our own reference range of TEG to guide the clinical blood transfusion and treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: March 10, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

(1) 18< Age <65, and Han Chinese residents living in Hunan more than 3 years. (2) Health examination population who physical examination, assistant examination and serological examination were normal; Not suffer from other diseases last 3 months; Not take any medication last 7 days.

Exclusion Criteria:

1. Informed refusal. 2. Pregnancy, woman with menstrual period; volunteers who suffer from hematological system diseases such as hemorrhagic or thrombotic disease and take medicines that affect the function of blood coagulation (clopidogrel and aspirin, warfarin, rivaroxaban, dipyridamole, oral contraceptives, estrogen, antibiotics and traditional Chinese medicine related with blood coagulation, etc.) 3. Volunteers who have a history of liver disease, immune system disease, allergy and other disease within the last 3 months were excluded.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Blood Transfusion Complication
• Coagulopathy
• Hemostatic Disorders
• Transfusion Reaction

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Third Xingya Hospital	Changsha	Hunan

Sponsors (5)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University	Changsha Central Hospital, Hunan Cancer Hospital, Hunan Provincial People's Hospital, Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (8)

Ak K, Isbir CS, Tetik S, Atalan N, Tekeli A, Aljodi M, Civelek A, Arsan S. Thromboelastography-based transfusion algorithm reduces blood product use after elective CABG: a prospective randomized study. J Card Surg. 2009 Jul-Aug;24(4):404-10. doi: 10.1111/j.1540-8191.2009.00840.x. — View Citation

Ji HW, Ma L, Gao XR, Liu N, Zhang Y, Wang Y, Ma ZX, Wang Y, Wang J, Fu X, Xiong Q, Qi HM. [Establishment of normal reference values for thromboelastography on Chinese population in Beijing]. Zhonghua Yi Xue Za Zhi. 2011 Apr 12;91(14):980-3. Chinese. — View Citation

Pfanner G, Koscielny J, Pernerstorfer T, Gütl M, Perger P, Fries D, Hofmann N, Innerhofer P, Kneifl W, Neuner L, Schöchl H, Kozek-Langenecker SA; Austrian Society for Anaesthesia, Resuscitation and Intensive Care. [Preoperative evaluation of the bleeding history. Recommendations of the working group on perioperative coagulation of the Austrian Society for Anaesthesia, Resuscitation and Intensive Care]. Anaesthesist. 2007 Jun;56(6):604-11. German. — View Citation

Subramanian A, Albert V, Saxena R, Agrawal D, Pandey RM. Establishing a normal reference range for thromboelastography in North Indian healthy volunteers. Indian J Pathol Microbiol. 2014 Jan-Mar;57(1):43-50. doi: 10.4103/0377-4929.130896. — View Citation

Sun W, Jeleniowski K, Zhao X, Shen P, Li D, Hammond JA. Thromboelastography (TEG)-based algorithm reduces blood product utilization in patients undergoing VAD implant. J Card Surg. 2014 Mar;29(2):238-43. — View Citation

Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY. Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial. Transplant Proc. 2010 Sep;42(7):2590-3. doi: 10.1016/j.transproceed.2010.05.144. — View Citation

Wesley MC, McGowan FX, Castro RA, Dissanayake S, Zurakowski D, Dinardo JA. The effect of milrinone on platelet activation as determined by TEG platelet mapping. Anesth Analg. 2009 May;108(5):1425-9. doi: 10.1213/ane.0b013e3181981fbe. — View Citation

Zambruni A, Thalheimer U, Leandro G, Perry D, Burroughs AK. Thromboelastography with citrated blood: comparability with native blood, stability of citrate storage and effect of repeated sampling. Blood Coagul Fibrinolysis. 2004 Jan;15(1):103-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thromboelastography normal reference values	The subjects with normal routine coagulation test results would be included.Thromboelastography was performed by using TEG-5000 TEG-CK (Hemostasis System, USA), and the parameters were recorded. Parameters includes R (coagulation reaction time, initial fibrin formation time), K (Coagulation time), a (a-angle, thrombosis rate), MA (maximum amplitude, absolute agglutination strength of reactive blood clot), LY30 (fibrinolysis rate with 30 min after MA determination) and CI (integrated coagulation index).	2017.6.1-2017.12.1