Cirrhosis, LiverSTRATEGICNCT05583539
Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis
A study testing Thromboelastography in people with Cirrhosis, Liver and Coagulopathy, run by Vanderbilt University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Coagulopathy, GastroIntestinal Bleeding
- What is being tested?
- Thromboelastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or older
- Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis
Who cannot join
- None
About this study
Official title: 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.
- Conditions
- Cirrhosis, Liver, Coagulopathy, GastroIntestinal Bleeding
- Being tested
- Thromboelastography
- Medical subject headings
- Liver Cirrhosis, Hemostatic Disorders, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyDiagnostic test
Thromboelastography is a viscoelastic test that measures the dynamics of blood clotting on whole blood samples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of fresh frozen plasma transfused
The total volume of fresh frozen plasma transfused
Measured: From time of randomization to hospital discharge, up to 3 months
Secondary outcomes (5)
Patients requiring fresh frozen plasma transfusion
Percentage of patients requiring a fresh frozen plasma transfusion
Measured: 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
Measured: 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: 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
Measured: 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
Measured: From time of randomization to hospital discharge, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start16 Jan 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Never IRB approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Rice, Vanderbilt University Medical Center
- Investigators
- Todd Rice, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583539
- Sponsor's protocol ID
- 221098
- Acronym
- STRATEGIC
- Status last verified
- Apr 2024
- First submitted
- 8 Oct 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 3308669D'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.
PubMed 12939586Tripodi 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.
PubMed 21751907Tripodi 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.
PubMed 17593061Nanchal 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.
PubMed 32058387O'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.
PubMed 30986390Rout 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.
PubMed 31008867Kumar 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.
PubMed 31148204
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Thromboelastography Guided Blood Product Transfusion for Patient With Cirrhosis and Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT05583539
- Acronym / sponsor ID
- STRATEGIC / 221098
- Conditions
- Cirrhosis, Liver, Coagulopathy, GastroIntestinal Bleeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never IRB approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Jan 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will receive usual care at the discretion of their providers. |
| Thromboelastography guided resuscitation | Experimental | Diagnostic Test: ThromboelastographyPatients will undergo thromboelastography testing that will be used by primary providers to guide blood product resuscitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient aged 18 years or older
- Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThromboelastographyThromboelastography is a viscoelastic test that measures the dynamics of blood clotting on whole blood samples. | Diagnostic test | Thromboelastography guided resuscitation |
Primary outcome
Volume of fresh frozen plasma transfused
Time frame: From time of randomization to hospital discharge, up to 3 months
The total volume of fresh frozen plasma transfused
5 secondary outcomes
Patients requiring fresh frozen plasma transfusion
Time frame: From time of randomization to hospital discharge, up to 3 months
Volume of platelets and cryoprecipitate transfused
Time frame: From time of randomization to hospital discharge, up to 3 months
Control of bleeding at 5 days
Time frame: Measured at 5 days from the time of octreotide order placement
Rebleeding at 42 days
Time frame: The earlier of 42 days from the time of octreotide placement or hospital discharge
Mortality rate during index hospitalization
Time frame: From time of randomization to hospital discharge, up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 3308669Lautt 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.
- Background: PubMed 12939586D'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.
- Background: PubMed 21751907Tripodi 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.
- Background: PubMed 17593061Tripodi 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.
- Background: PubMed 32058387Nanchal 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.
- Background: PubMed 30986390O'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.
- Background: PubMed 31008867Rout 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.
- Background: PubMed 31148204Kumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Rice, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Thromboelastography in people with Cirrhosis, Liver and Coagulopathy, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of fresh frozen plasma transfused (time frame: From time of randomization to hospital discharge, up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05583539, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.