Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis

Cirrhosis, Liver Clinical Trial

— STRATEGIC  

Official title:

A Pilot Study of Thromboelastography Guided Blood Product Transfusion for Patient With Cirrhosis and Upper Gastrointestinal Bleeding

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05583539
• Other study ID #: 221098
• Status: Withdrawn
• Phase: N/A
• Start date: January 16, 2025
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare resuscitation strategies in patients with cirrhosis and gastrointestinal bleeding. The main question it aims to answer is whether thromboelastography guided resuscitation decreased the amount of fresh frozen plasma patients receive. Patients will receive blood products guided by thromboelastography in the intervention group. Researchers will compare the patients who undergo thromboelastography guided resuscitation to those who receive usual care to see which strategy leads to the use of less blood products, specifically less fresh frozen plasma.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged 18 years or older

• Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Coagulopathy
• Fibrosis
• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Liver Cirrhosis

Intervention

Diagnostic Test:
• Thromboelastography
Thromboelastography is a viscoelastic test that measures the dynamics of blood clotting on whole blood samples.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

References & Publications (8)

D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385. — View Citation

Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27. — View Citation

Lautt WW, Greenway CV. Conceptual review of the hepatic vascular bed. Hepatology. 1987 Sep-Oct;7(5):952-63. doi: 10.1002/hep.1840070527. No abstract available. — View Citation

Nanchal R, Subramanian R, Karvellas CJ, Hollenberg SM, Peppard WJ, Singbartl K, Truwit J, Al-Khafaji AH, Killian AJ, Alquraini M, Alshammari K, Alshamsi F, Belley-Cote E, Cartin-Ceba R, Dionne JC, Galusca DM, Huang DT, Hyzy RC, Junek M, Kandiah P, Kumar G, Morgan RL, Morris PE, Olson JC, Sieracki R, Steadman R, Taylor B, Alhazzani W. Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Cardiovascular, Endocrine, Hematologic, Pulmonary, and Renal Considerations. Crit Care Med. 2020 Mar;48(3):e173-e191. doi: 10.1097/CCM.0000000000004192. — View Citation

O'Leary JG, Greenberg CS, Patton HM, Caldwell SH. AGA Clinical Practice Update: Coagulation in Cirrhosis. Gastroenterology. 2019 Jul;157(1):34-43.e1. doi: 10.1053/j.gastro.2019.03.070. Epub 2019 Apr 12. — View Citation

Rout G, Shalimar, Gunjan D, Mahapatra SJ, Kedia S, Garg PK, Nayak B. Thromboelastography-guided Blood Product Transfusion in Cirrhosis Patients With Variceal Bleeding: A Randomized Controlled Trial. J Clin Gastroenterol. 2020 Mar;54(3):255-262. doi: 10.1097/MCG.0000000000001214. — View Citation

Tripodi A, Caldwell SH, Hoffman M, Trotter JF, Sanyal AJ. Review article: the prothrombin time test as a measure of bleeding risk and prognosis in liver disease. Aliment Pharmacol Ther. 2007 Jul 15;26(2):141-8. doi: 10.1111/j.1365-2036.2007.03369.x. — View Citation

Tripodi A, Mannucci PM. The coagulopathy of chronic liver disease. N Engl J Med. 2011 Jul 14;365(2):147-56. doi: 10.1056/NEJMra1011170. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of transfusion reactions	Percentage of patients who experienced a transfusion reaction	From time of randomization to hospital discharge, up to 3 months
Primary	Volume of fresh frozen plasma transfused	The total volume of fresh frozen plasma transfused	From time of randomization to hospital discharge, up to 3 months
Secondary	Patients requiring fresh frozen plasma transfusion	Percentage of patients requiring a fresh frozen plasma transfusion	From time of randomization to hospital discharge, up to 3 months
Secondary	Volume of platelets and cryoprecipitate transfused	The total combined volume of platelets and cryoprecipitate transfused	From time of randomization to hospital discharge, up to 3 months
Secondary	Control of bleeding at 5 days	Percentage of patients who have bleeding controlled at 5 days	Measured at 5 days from the time of octreotide order placement
Secondary	Rebleeding at 42 days	Percentage of patients who experienced in-hospital rebleeding within 42 days	The earlier of 42 days from the time of octreotide placement or hospital discharge
Secondary	Mortality rate during index hospitalization	Percentage of patients who died during the index hospitalization	From time of randomization to hospital discharge, up to 3 months