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Completed

NCT Number: NCT03146455

Thromboelastography Normal Reference Values in China Hunan Province

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Third Xingya Hospital

Changsha, Hunan, 410013, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. thromboelastography normal reference values

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • Changsha Central Hospital
  • Hunan Cancer Hospital
  • Hunan Provincial People's Hospital
  • Second Xiangya Hospital of Central South University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 10, 2017
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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