Acute on Chronic Liver FailurePhase 4NCT02757170
Assessment of Coagulation Abnormalities in Acute on Chronic Liver Failure Patients Using Thromboelastography
A Phase 4 study testing Thromboelastography in people with Acute on Chronic Liver Failure and Cirrhosis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Patients of acute \& chronic liver failure have long been assumed to have coagulopathy \& are given blood products prophylactically as well as during various interventions. But these patients rarely have spontaneous bleed except variceal bleed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute on Chronic Liver Failure, Cirrhosis
- What is being tested?
- Thromboelastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2015to Jul 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All consecutive ALF, ACLF \& cirrhotic patients and healthy controls
- Written informed consent (patient or his nearest relative)
Who cannot join
- Patients on anti-platelet or anticoagulant therapy
- Pregnancy and immediate post-partum period
- History of underlying hypercoagulable/ hypocoagulable states eg. PNH, Polycythemia, Hemophilia
- Patients with renal failure
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr. S K Acharya
New Delhi, New Delhi, 110029
Subrat K Acharya, DM, 01126594425, subratacharya@gmail.com
Subrat K Acharya, DM, 9868397200, subratacharya@hotmail.com
About this study
Patients of acute \& chronic liver failure have long been assumed to have coagulopathy \& are given blood products prophylactically as well as during various interventions. But these patients rarely have spontaneous bleed except variceal bleed. Conventional coagulation parameters are insufficient to assess coagulation status of these patients because they reflect only a certain element of coagulation cascade while thromboelastography (TEG) gives a comprehensive report of hemostatic profile including platelet function. Studies using TEG have suggested that defects in prohemostatic drivers are counterbalanced by changes in antihemostatic drivers creating a rebalance in these patients. Acute on chronic failure is a entity with acute decompensation on underlying chronic liver failure. Since there is paucity of data regarding coagulation abnormalities in these patient, study is needed to assess predictability power of TEG in these patients with respect to coagulation abnormalities in patient with ALF and CLD ( cirrhosis) and healthy controls.
Read the detailed description
Since early times coagulopathy is considered to be an integral part of liver failure. Whether it is acute liver failure (ALF) or acute on chronic liver failure (ACLF), patients usually have deranged coagulation parameters (platelet count, prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR). Based on these deranged parameters, initially it was assumed that patients of liver failure have increased risk of bleeding \& usually were given blood products prophylactically during surgical interventions. But these patients of liver failure (acute or chronic) seldom develop spontaneous bleeding, apart from variceal bleeding in chronic liver failure which generally occurs because of portal hypertension. Moreover during invasive procedures also they do not have significant bleeding.
Concept of rebalanced hemostasis has been proposed to explain discrepancy between results of these coagulation parameters \& clinical scenario of patients. Normal hemostasis consists of 3 steps: platelet endothelial interaction, coagulation \& fibrinolysis. First step is considered to be defective in liver failure because of thrombocytopenia \& qualitative platelet dysfunction. However because of decreased plasma concentration of ADAMTS 13, plasma levels of vwF are increased thus increasing stickiness of platelets \& rebalancing the primary hemostasis.
Because of deranged INR, it is thought that coagulation cascade is deranged but Tripodi et al have shown that cirrhotics also can generate same amount of thrombin as healthy subjects. All procoagulants (factor II, V, VII, IX, X, XI) \& anticoagulant factors (protein C, protein S \& antithrombin) except factor VIII are synthesized in liver. Decreased procoagulant activity has been found to be counterbalanced by decreased anticoagulant proteins, thus rebalancing the whole coagulation process.
Finally, there is increased fibrinolytic activity and clot instability because of increased tissue plasminogen activator (tPA) with low levels of alpha 2 antiplasmin, factor XIII and reduced thrombin activated fibrinolysis inhibitor (TAFI). However, this is balanced by increased levels of acute phase reactant plasminogen activator inhibitor (PAI-1).
Conventional parameters like INR although can predict mortality in these cases but don't predict risk of bleeding in these patients because they monitor only a part of coagulation cascade. These parameters assess clot formation in plasma environment while in Thromboelastography (TEG) whole blood i.e. both plasma \& cellular components including platelets are assessed \& a collective report of hemostatic profile of patient is available. Graph obtained using TEG gives 5 values including r time, k time, α angle, maximum amplitude \& lysis at 30 min assessing different aspects. It has been widely used prior to cardiac surgery and liver transplant surgery to assess for coagulation defects.
In patients with stable cirrhosis, the TEG parameters are reported to lie within normal limits. TEG measurements done serially have been shown to be better than routine coagulation tests in measuring hypocoagulability in cirrhotics with early rebleeding. In decompensated cirrhotic patients, bacterial infections are common and impair hemostasis. The TEG parameters are impaired on the day of infection and recover to normal values in 5 days in cases showing response to treatment.
The results of TEG in ALF have been contrasting in the two studies which included predominantly paracetamol induced ALF. Stravitz et al in a study of 51 ALF patients reported normal TEG in 63%, 1 abnormality in 16%, 2 abnormalities in 10%, 3 abnormalities in 8% of patients and 4 abnormalities in 4% whereas 8% patients had TEG parameters in a hypercoagulable range though the mean of parameters were within normal limits in all patients. In another study of 20 ALF patients, TEG findings were consistent with a hypocoagulable state in 20%, normal in 45%, and hypercoagulable in 35% of the patients.
Acute on chronic liver failure is a recently defined entity with prolonged INR being a component of definition. The exact nature of coagulopathy in this disease has not yet been studied. In this prospective study, we propose to study the role of TEG in assessing the coagulation state in patients with ACLF and comparing the TEG parameters with respect to patients with ALF, CLD and healthy controls.
- Conditions
- Acute on Chronic Liver Failure, Cirrhosis
- Being tested
- Thromboelastography
- Medical subject headings
- Acute-On-Chronic Liver Failure, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyDevice
Patients whole blood will be subjected to undergo coagulation process under monitoring with thromboelastography and various tracings will be recorded and will be interpreted as results.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Thromboelastography Acute on chronic liver failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients Receives: Device: Thromboelastography |
| Group II | Active comparator | Thromboelastography Healthy Controls: Healthy persons' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation. Receives: Device: Thromboelastography |
| Group III | Experimental | Thromboelastography Chronic Liver Failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients Receives: Device: Thromboelastography |
| Group IV | Experimental | Thromboelastography Acute Liver Failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients Receives: Device: Thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in r, k and MA- TEG parameters in ACLF
Measured: 1 day
Secondary outcomes (3)
Comparison of r, k and MA- TEG parameters with conventional tests of coagulation (i.e PT, aPTT)
Measured: 1 day
Development of renal failure, progression of hepatic encephalopathy, variceal bleeding and sepsis in patients with r, k and MA- TEG parameters
Measured: 28 days
Death in patients with abnormal r, k and MA- TEG parameters
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
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 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subrat Kumar Acharya, All India Institute of Medical Sciences
- Investigators
- Subrat k Acharya, DM, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757170
- Sponsor's protocol ID
- IESC/T-203/05.05.15
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coagulation Abnormalities in Acute on Chronic Liver Failure Patients Using Thromboelastography
- ClinicalTrials.gov ID
- NCT02757170
- Acronym / sponsor ID
- IESC/T-203/05.05.15
- Conditions
- Acute on Chronic Liver Failure, Cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 2 May 2016 (estimated)
- 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.
Patients of acute \& chronic liver failure have long been assumed to have coagulopathy \& are given blood products prophylactically as well as during various interventions. But these patients rarely have spontaneous bleed except variceal bleed. Conventional coagulation parameters are insufficient to assess coagulation status of these patients because they reflect only a certain element of coagulation cascade while thromboelastography (TEG) gives a comprehensive report of hemostatic profile including platelet function. Studies using TEG have suggested that defects in prohemostatic drivers are counterbalanced by changes in antihemostatic drivers creating a rebalance in these patients. Acute on chronic failure is a entity with acute decompensation on underlying chronic liver failure. Since there is paucity of data regarding coagulation abnormalities in these patient, study is needed to assess predictability power of TEG in these patients with respect to coagulation abnormalities in patient with ALF and CLD ( cirrhosis) and healthy controls.
Detailed description
Since early times coagulopathy is considered to be an integral part of liver failure. Whether it is acute liver failure (ALF) or acute on chronic liver failure (ACLF), patients usually have deranged coagulation parameters (platelet count, prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR). Based on these deranged parameters, initially it was assumed that patients of liver failure have increased risk of bleeding \& usually were given blood products prophylactically during surgical interventions. But these patients of liver failure (acute or chronic) seldom develop spontaneous bleeding, apart from variceal bleeding in chronic liver failure which generally occurs because of portal hypertension. Moreover during invasive procedures also they do not have significant bleeding.
Concept of rebalanced hemostasis has been proposed to explain discrepancy between results of these coagulation parameters \& clinical scenario of patients. Normal hemostasis consists of 3 steps: platelet endothelial interaction, coagulation \& fibrinolysis. First step is considered to be defective in liver failure because of thrombocytopenia \& qualitative platelet dysfunction. However because of decreased plasma concentration of ADAMTS 13, plasma levels of vwF are increased thus increasing stickiness of platelets \& rebalancing the primary hemostasis.
Because of deranged INR, it is thought that coagulation cascade is deranged but Tripodi et al have shown that cirrhotics also can generate same amount of thrombin as healthy subjects. All procoagulants (factor II, V, VII, IX, X, XI) \& anticoagulant factors (protein C, protein S \& antithrombin) except factor VIII are synthesized in liver. Decreased procoagulant activity has been found to be counterbalanced by decreased anticoagulant proteins, thus rebalancing the whole coagulation process.
Finally, there is increased fibrinolytic activity and clot instability because of increased tissue plasminogen activator (tPA) with low levels of alpha 2 antiplasmin, factor XIII and reduced thrombin activated fibrinolysis inhibitor (TAFI). However, this is balanced by increased levels of acute phase reactant plasminogen activator inhibitor (PAI-1).
Conventional parameters like INR although can predict mortality in these cases but don't predict risk of bleeding in these patients because they monitor only a part of coagulation cascade. These parameters assess clot formation in plasma environment while in Thromboelastography (TEG) whole blood i.e. both plasma \& cellular components including platelets are assessed \& a collective report of hemostatic profile of patient is available. Graph obtained using TEG gives 5 values including r time, k time, α angle, maximum amplitude \& lysis at 30 min assessing different aspects. It has been widely used prior to cardiac surgery and liver transplant surgery to assess for coagulation defects.
In patients with stable cirrhosis, the TEG parameters are reported to lie within normal limits. TEG measurements done serially have been shown to be better than routine coagulation tests in measuring hypocoagulability in cirrhotics with early rebleeding. In decompensated cirrhotic patients, bacterial infections are common and impair hemostasis. The TEG parameters are impaired on the day of infection and recover to normal values in 5 days in cases showing response to treatment.
The results of TEG in ALF have been contrasting in the two studies which included predominantly paracetamol induced ALF. Stravitz et al in a study of 51 ALF patients reported normal TEG in 63%, 1 abnormality in 16%, 2 abnormalities in 10%, 3 abnormalities in 8% of patients and 4 abnormalities in 4% whereas 8% patients had TEG parameters in a hypercoagulable range though the mean of parameters were within normal limits in all patients. In another study of 20 ALF patients, TEG findings were consistent with a hypocoagulable state in 20%, normal in 45%, and hypercoagulable in 35% of the patients.
Acute on chronic liver failure is a recently defined entity with prolonged INR being a component of definition. The exact nature of coagulopathy in this disease has not yet been studied. In this prospective study, we propose to study the role of TEG in assessing the coagulation state in patients with ACLF and comparing the TEG parameters with respect to patients with ALF, CLD and healthy controls.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: ThromboelastographyThromboelastography Acute on chronic liver failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients |
| Group II | Active comparator | Device: ThromboelastographyThromboelastography Healthy Controls: Healthy persons' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation. |
| Group III | Experimental | Device: ThromboelastographyThromboelastography Chronic Liver Failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients |
| Group IV | Experimental | Device: ThromboelastographyThromboelastography Acute Liver Failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All consecutive ALF, ACLF \& cirrhotic patients and healthy controls
- Written informed consent (patient or his nearest relative)
Key exclusion criteria (4 listed)
- Patients on anti-platelet or anticoagulant therapy
- Pregnancy and immediate post-partum period
- History of underlying hypercoagulable/ hypocoagulable states eg. PNH, Polycythemia, Hemophilia
- Patients with renal failure
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 |
|---|---|---|
| ThromboelastographyPatients whole blood will be subjected to undergo coagulation process under monitoring with thromboelastography and various tracings will be recorded and will be interpreted as results. | Device | Group II, Group III, Group IV, I |
Primary outcome
Changes in r, k and MA- TEG parameters in ACLF
Time frame: 1 day
3 secondary outcomes
Comparison of r, k and MA- TEG parameters with conventional tests of coagulation (i.e PT, aPTT)
Time frame: 1 day
Development of renal failure, progression of hepatic encephalopathy, variceal bleeding and sepsis in patients with r, k and MA- TEG parameters
Time frame: 28 days
Death in patients with abnormal r, k and MA- TEG parameters
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Acute on Chronic Liver Failure
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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CytOSorb TreatMent Of Critically Ill PatientS Registry
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Very Low-volume Plasma Exchange in ACLF
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A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
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.
Subrat k Acharya, DM principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thromboelastography in people with Acute on Chronic Liver Failure and Cirrhosis, run by All India Institute of Medical Sciences 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 May 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Subrat K Acharya, DM (01126594425, subratacharya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in r, k and MA- TEG parameters in ACLF (time frame: 1 day). 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 2 May 2016.