Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis

NCT05583539 | Withdrawn FDA Device

• 1 other identifier: 221098
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cirrhosis, Liver; Coagulopathy; GastroIntestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patients requiring fresh frozen plasma transfusion

  From time of randomization to hospital discharge, up to 3 months

• Volume of platelets and cryoprecipitate transfused

  From time of randomization to hospital discharge, up to 3 months

• Control of bleeding at 5 days

  Measured at 5 days from the time of octreotide order placement

• Rebleeding at 42 days

  The earlier of 42 days from the time of octreotide placement or hospital discharge

• Mortality rate during index hospitalization

  From time of randomization to hospital discharge, up to 3 months

Other Outcomes (1)

• Rate of transfusion reactions

  From time of randomization to hospital discharge, up to 3 months

Study Arms (2)

Usual Care

NO INTERVENTION

Patients will receive usual care at the discretion of their providers.

Thromboelastography guided resuscitation

EXPERIMENTAL

Patients will undergo thromboelastography testing that will be used by primary providers to guide blood product resuscitation.

Diagnostic Test: Thromboelastography

Interventions

Thromboelastography DIAGNOSTIC_TEST

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

Thromboelastography guided resuscitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Related Publications (8)

• 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.

  PMID: 3308669 BACKGROUND

• 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.

  PMID: 12939586 BACKGROUND

• 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.

  PMID: 21751907 BACKGROUND

• 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.

  PMID: 17593061 BACKGROUND

• 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.

  PMID: 32058387 BACKGROUND

• 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.

  PMID: 30986390 BACKGROUND

• 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.

  PMID: 31008867 BACKGROUND

• 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.

  PMID: 31148204 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Hemostatic Disorders; Gastrointestinal Hemorrhage

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Gastrointestinal Diseases; Hemorrhage

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Todd Rice, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 17, 2022
• Study Start: January 16, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04