STRATEGIC: Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
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Outcome Measures
Primary Outcome Measures
- Volume of fresh frozen plasma transfused [From time of randomization to hospital discharge, up to 3 months]
The total volume of fresh frozen plasma transfused
Secondary Outcome Measures
- Patients requiring fresh frozen plasma transfusion [From time of randomization to hospital discharge, up to 3 months]
Percentage of patients requiring a fresh frozen plasma transfusion
- Volume of platelets and cryoprecipitate transfused [From time of randomization to hospital discharge, up to 3 months]
The total combined volume of platelets and cryoprecipitate transfused
- Control of bleeding at 5 days [Measured at 5 days from the time of octreotide order placement]
Percentage of patients who have bleeding controlled at 5 days
- Rebleeding at 42 days [The earlier of 42 days from the time of octreotide placement or hospital discharge]
Percentage of patients who experienced in-hospital rebleeding within 42 days
- Mortality rate during index hospitalization [From time of randomization to hospital discharge, up to 3 months]
Percentage of patients who died during the index hospitalization
Other Outcome Measures
- Rate of transfusion reactions [From time of randomization to hospital discharge, up to 3 months]
Percentage of patients who experienced a transfusion reaction
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient aged 18 years or older
-
Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis
Exclusion Criteria:
- None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
- Principal Investigator: Tanya Marvi, MD, Vanderbilt University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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