Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis (STRATEGIC)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cirrhosis, Liver; Coagulopathy; GastroIntestinal Bleeding
• Intervention / Treatment: Diagnostic test: Thromboelastography

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged 18 years or older
• Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Patients will receive usual care at the discretion of their providers.
Experimental: Thromboelastography guided resuscitation; Patients will undergo thromboelastography testing that will be used by primary providers to guide blood product resuscitation.	Diagnostic test: Thromboelastography; Thromboelastography is a viscoelastic test that measures the dynamics of blood clotting on whole blood samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of transfusion reactions	Percentage of patients who experienced a transfusion reaction	From time of randomization to hospital discharge, up to 3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Todd Rice, MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 16, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Fibrosis; Hemorrhage; Liver Cirrhosis; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 221098

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes