Thromboelastography Normal Reference Values in China Hunan Province

Completed

• Conditions: Blood Transfusion Complication; Coagulopathy

• Registration Number: NCT03146455
• Lead Sponsor: The Third Xiangya Hospital of Central South University

Brief 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.

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 Timeline

• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-07
• Study First Posted: 2017-05-10
• Study Start: 2017-06-05
• Primary Completion: 2018-01-01
• Status Verified: 2018-03
• Study Completion: 2018-03-10
• Last Update Submitted: 2018-03-24
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thromboelastography normal reference values	2017.6.1-2017.12.1	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).

Trial Locations

Locations (1)

Third Xingya Hospital; 🇨🇳 Changsha, Hunan, China