Thromboelastography Normal Reference Values in China Hunan Province

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

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.

Study Overview

• Status: Completed
• Conditions: Coagulopathy; Blood Transfusion Complication
• Intervention / Treatment: Other: no intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 498

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Third Xingya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Permanent resident in Hunan, 18< Age <65.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Health adults; (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.	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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), α (α-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

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Collaborators: Hunan Cancer Hospital; Hunan Provincial People's Hospital; Second Xiangya Hospital of Central South University; Changsha Central Hospital

Publications and helpful links

General Publications

• 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.
• Pfanner G, Koscielny J, Pernerstorfer T, Gutl M, Perger P, Fries D, Hofmann N, Innerhofer P, Kneifl W, Neuner L, Schochl 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. doi: 10.1007/s00101-007-1182-0. German.
• 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. doi: 10.1111/jocs.12302.
• 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.
• 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.
• 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. doi: 10.1097/00001721-200401000-00017.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2017
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): March 10, 2018

Study Registration Dates

• First Submitted: May 7, 2017
• First Submitted That Met QC Criteria: May 7, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 24, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Blood Transfusion; reference ranges; Thrombelastograghy; racial; geographic
• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: ThirdXiangyaHCSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No