Acute on Chronic Liver FailureGOODHEART-ACLFNCT05124041
Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy
A study testing Rotational thromboelastometry in people with Acute on Chronic Liver Failure and Variceal Hemorrhage, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
In this project, we plan to evaluate whether a new, rotational thromboelastometry-guided algorithm (ROTEM) to guide hemostatic resuscitation decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute on Chronic Liver Failure, Variceal Hemorrhage, Cirrhosis, Liver
- What is being tested?
- Rotational thromboelastometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2021to 15 Jan 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- ACLF, as diagnosed by CANONIC/ APASL criteria .
- Upper gastrointestinal bleeding
Who cannot join
- Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
- HIV positive/ AIDS patients
- Patients requiring antiplatelet therapy,
- Renal insufficiency requiring dialysis
- Active malignancy within the last 5 years
- Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease
- Administration of anticoagulants, antifibrinolytics,
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, Choose Any State/Province, 160012
About this study
Official title: Thromboelastometry Guided Transfusion Protocol Versus Standard Care in Acute-on-Chronic Liver Failure With Bleeding: A Prospective Intervention Trial
In this project, we plan to evaluate whether a new, rotational thromboelastometry-guided algorithm (ROTEM) to guide hemostatic resuscitation decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured.
We plan to enroll 260 patients having ACLF with variceal bleeding randomized into two groups: one will be treated conventionally using clinical judgement and standard coagulation tests such as prothrombin time, platelet count, etc. the other treated using a ROTEM-based algorithm. They will be followed for development of rebleeding, complications of transfusion and any signs of infection after hospitalization
Read more
There will be a 'no intervention' group with well controlled bleeding who will undergo VETs but not be offered coagulation correction prophylactically in accordance with the Baveno VII consensus. This control group will be followed up in parallel with the main intervention groups.
The ROTEM or SCT based correction will only be offered to patients who have high risk for rebleeding/ failure to control bleeding/ active bleeding at endoscopy/ need SEMS/TIPS and such individuals will be randomized to 2 arms ROTEM vs SCT, with 130 in each arm.
Read the detailed description
Patients with acute-on-chronic liver failure (ACLF) have coagulation failure in the setting of systemic inflammatory syndrome (SIRS), sepsis and extra-hepatic organ failures. The utility of thromboelastography/thromboelastometry currently has unvalidated clinical benefit in the assessment and reversal of coagulopathy among cirrhotic patients as compared to standard coagulation testing.Need for periprocedural blood transfusion is still high in patients with decompensated cirrhosis or ACLF who present with major bleeding. Allogeneic blood transfusion may be detrimental in patients with cirrhosis, due to volume overload and acute lung injury. Viscoelastic testing of global coagulation such as thromboelastometry has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. In prior studies, we have clarified the pathophysiology of hemostasis in relation to the evidence of sepsis in liver disease and described the accuracy of various available laboratory tests in assessment of these patients. We have described the role of endogenous heparinoids in severe alcoholic hepatitis and the pathogenesis of the coagulation defect in ACLF. We determined the influence of sepsis on coagulation disorders in ACLF patients, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.
- Conditions
- Acute on Chronic Liver Failure, Variceal Hemorrhage, Cirrhosis, Liver, Thromboelastometry, Thrombosis;Portal
- Being tested
- Rotational thromboelastometry
- Medical subject headings
- Acute-On-Chronic Liver Failure, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational thromboelastometryDiagnostic test
ROTEM-guided protocol of hemostatic resuscitation
| Study group | Role | What they receive |
|---|---|---|
| ROTEM-arm | Experimental | Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis Receives: Diagnostic Test: Rotational thromboelastometry |
| Control-arm | Active comparator | Treatment of significant blood loss conventionally, ie. using clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma Receives: Diagnostic Test: Rotational thromboelastometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical control of bleeding
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Measured: 24 hours
Number of participants with clinical control of bleeding
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Measured: 5 days
Number of participants with clinical control of bleeding
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Measured: 42 days
Secondary outcomes (4)
Duration of Intensive care admission
Measured: 30 days after bleeding episode treated by transfusion protocol
Duration of hospital stay
Measured: 30 days after bleeding episode treated by transfusion protocol
Number of Participants with Transfusion-related side effects
The number and type of coagulation directed blood components fresh frozen plasma, platelet concentrate, fibrinogen concentrate and cryoprecipitate and adverse events related will be assessed in either arm.
Measured: 30 days after bleeding episode treated by transfusion protocol
Number of Participants with Thromboembolic events
Measured: 30 days after bleeding episode treated by transfusion protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start15 Nov 2021
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Liver FailureStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 260 patients having ACLF with bleeding will be randomized into two groups. One will be treated conventionally, i.e. using clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm Revised Eligibility criteria as per Baveno VII ACLF with variceal bleeding with any indication for blood component transfusion as below Indications for transfusion in either arm are 1. Multiple sites of bleed e.g. diffuse mucosal ooze, post EVL ulcers, diffuse portal hypertensive gastropathy, etc which are associated with coagulation dysfunction against a background of portal hypertensive bleeding 2. Failure to control bleeding 3. Early rebleeding 4. Active bleeding on endoscopy with refractory variceal bleeding, need for balloon tamponade or self expandable metal stents (SEMS) 5. At the time of bridge therapy to a more definite treatment such as PTFE covered TIPS.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124041
- Sponsor's protocol ID
- PGI/IEC/2020/000268
- Other IDs
- PGI/IEC/2024/EIC000462 27.3.24
- Acronym
- GOODHEART-ACLF
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastometry Guided Transfusion Protocol Versus Standard Care in Acute-on-Chronic Liver Failure With Bleeding: A Prospective Intervention Trial
- ClinicalTrials.gov ID
- NCT05124041
- Acronym / sponsor ID
- GOODHEART-ACLF / PGI/IEC/2020/000268
- Conditions
- Acute on Chronic Liver Failure, Variceal Hemorrhage, Cirrhosis, Liver, Thromboelastometry, Thrombosis;Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 17 Nov 2021 (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.
In this project, we plan to evaluate whether a new, rotational thromboelastometry-guided algorithm (ROTEM) to guide hemostatic resuscitation decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured.
We plan to enroll 260 patients having ACLF with variceal bleeding randomized into two groups: one will be treated conventionally using clinical judgement and standard coagulation tests such as prothrombin time, platelet count, etc. the other treated using a ROTEM-based algorithm. They will be followed for development of rebleeding, complications of transfusion and any signs of infection after hospitalization
There will be a 'no intervention' group with well controlled bleeding who will undergo VETs but not be offered coagulation correction prophylactically in accordance with the Baveno VII consensus. This control group will be followed up in parallel with the main intervention groups.
The ROTEM or SCT based correction will only be offered to patients who have high risk for rebleeding/ failure to control bleeding/ active bleeding at endoscopy/ need SEMS/TIPS and such individuals will be randomized to 2 arms ROTEM vs SCT, with 130 in each arm.
Detailed description
Patients with acute-on-chronic liver failure (ACLF) have coagulation failure in the setting of systemic inflammatory syndrome (SIRS), sepsis and extra-hepatic organ failures. The utility of thromboelastography/thromboelastometry currently has unvalidated clinical benefit in the assessment and reversal of coagulopathy among cirrhotic patients as compared to standard coagulation testing.Need for periprocedural blood transfusion is still high in patients with decompensated cirrhosis or ACLF who present with major bleeding. Allogeneic blood transfusion may be detrimental in patients with cirrhosis, due to volume overload and acute lung injury. Viscoelastic testing of global coagulation such as thromboelastometry has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. In prior studies, we have clarified the pathophysiology of hemostasis in relation to the evidence of sepsis in liver disease and described the accuracy of various available laboratory tests in assessment of these patients. We have described the role of endogenous heparinoids in severe alcoholic hepatitis and the pathogenesis of the coagulation defect in ACLF. We determined the influence of sepsis on coagulation disorders in ACLF patients, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 260 patients having ACLF with bleeding will be randomized into two groups. One will be treated conventionally, i.e. using clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm Revised Eligibility criteria as per Baveno VII ACLF with variceal bleeding with any indication for blood component transfusion as below Indications for transfusion in either arm are 1. Multiple sites of bleed e.g. diffuse mucosal ooze, post EVL ulcers, diffuse portal hypertensive gastropathy, etc which are associated with coagulation dysfunction against a background of portal hypertensive bleeding 2. Failure to control bleeding 3. Early rebleeding 4. Active bleeding on endoscopy with refractory variceal bleeding, need for balloon tamponade or self expandable metal stents (SEMS) 5. At the time of bridge therapy to a more definite treatment such as PTFE covered TIPS.
| Arm | Type | Receives |
|---|---|---|
| ROTEM-arm | Experimental | Diagnostic Test: Rotational thromboelastometryTreatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis |
| Control-arm | Active comparator | Diagnostic Test: Rotational thromboelastometryTreatment of significant blood loss conventionally, ie. using clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- ACLF, as diagnosed by CANONIC/ APASL criteria .
- Upper gastrointestinal bleeding
Key exclusion criteria (8 listed)
- Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
- HIV positive/ AIDS patients
- Patients requiring antiplatelet therapy,
- Renal insufficiency requiring dialysis
- Active malignancy within the last 5 years
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 |
|---|---|---|
| Rotational thromboelastometryROTEM-guided protocol of hemostatic resuscitation | Diagnostic test | Control-arm, ROTEM-arm |
Primary outcome
Number of participants with clinical control of bleeding
Time frame: 24 hours
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Number of participants with clinical control of bleeding
Time frame: 5 days
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Number of participants with clinical control of bleeding
Time frame: 42 days
Clinical control of bleeding at 24 hours, at Day 5 and day 42
4 secondary outcomes
Duration of Intensive care admission
Time frame: 30 days after bleeding episode treated by transfusion protocol
Duration of hospital stay
Time frame: 30 days after bleeding episode treated by transfusion protocol
Number of Participants with Transfusion-related side effects
Time frame: 30 days after bleeding episode treated by transfusion protocol
Number of Participants with Thromboembolic events
Time frame: 30 days after bleeding episode treated by transfusion protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotational thromboelastometry in people with Acute on Chronic Liver Failure and Variceal Hemorrhage, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with clinical control of bleeding (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.