Thromboelastography Normal Reference Values in China Hunan Province

NCT03146455 | Completed DMC

• 1 other identifier: ThirdXiangyaHCSU
• Study Type: observational
• Target: 498
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulopathy; Blood Transfusion Complication

Keywords

Thrombelastograghy; reference ranges; racial; geographic; Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

no intervention OTHER

no intervention

Health adults

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Permanent resident in Hunan, 18\< Age \<65.

You may qualify if:

• (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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Second Xiangya Hospital of Central South University: collaborator
• Hunan Provincial People's Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• Changsha Central Hospital: collaborator

Study Sites (1)

Third Xingya Hospital

Changsha, Hunan, 410013, China

Location

Related Publications (8)

• 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.

  PMID: 17522829 BACKGROUND

• 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.

  PMID: 24734284 BACKGROUND

• 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.

  PMID: 19372315 BACKGROUND

• 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.

  PMID: 20832550 BACKGROUND

• 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.

  PMID: 19583608 BACKGROUND

• 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.

  PMID: 15166952 BACKGROUND

• 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.

  PMID: 24739830 BACKGROUND

• 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.

  PMID: 21609551 BACKGROUND

MeSH Terms

Conditions

Hemostatic Disorders; Transfusion Reaction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Blood transfusion

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 10, 2017
• Study Start: June 5, 2017
• Primary Completion: January 1, 2018
• Study Completion: March 10, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)