Liver CirrhosisNCT05333510
A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction
An observational study of Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2021to 8 Jan 2022
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of liver cirrhosis who are presenting with non variceal bleed would be included in this study
Who may be able to join
- patients of liver cirrhosis with non variceal bleed
Who cannot join
- Pregnant and postpartum patients
- died within the first 24hours of admission.
- variceal and postvariceal ligation ulcer bleed.
- On anticoagulants or antiplatelets at the time of admission in ICU
- Transfusion with blood products before admission to the ICU.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Comparative Evaluation of Thromboelastography Versus Thromboelastometry for Coagulopathy Correction in Patients of Liver Cirrhosis With Non Variceal Bleed- Prospective Observational Study
Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited.
Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients.
In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding
Read the detailed description
Thromboelastography (TEG) and thromboelastometry( ROTEM) are point-of-care, global hemostasis assessment tests that measure the viscoelastic changes that occur during the hemostatic process.
Patients with cirrhosis have an imbalance of procoagulants and anticoagulants combined with alterations in fibrinolysis ,platelet number and function.
Point of care viscoelastic tests (TEG ,ROTEM) demonstrate specific functional coagulation defects that can direct blood component transfusion therapy in cirrhosis, with clinical validation of individual parameters.
Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited.
Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients.
In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding
- Conditions
- Liver Cirrhosis
- Keywords
- THROMBOELASTOGRAPHY, THROMBOELASTOMETRY, nonvariceal, bleeding
- Medical subject headings
- Liver Cirrhosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TEG group | Thromboelastography guided blood product administration in patients of liver cirrhosis with non variceal bleed | |
| ROTEM group | Throboelastometry guided blood product administration in patients of liver cirrhosis with non variceal bleed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured
Measured: 8 hours
Secondary outcomes (10)
R time of thromboelastography
R time measures time to start forming clot
Measured: 8 hours
K time of thromboelastography
K time represents time until clot reaches a fixed strength
Measured: 8 hours
alpha angle of thromboelastography
alpha angle represents speed of fibrin accumulation
Measured: 8 hours
Maximum amplitude of thromboleastography
It represents the highest vertical amplitude of thromboelastography
Measured: 8 hours
LY30 Iin thromboelastometry
It represents the percentage of amplitude reduction 30 minutes after reaching maximum amplitude
Measured: 8 hours
Clotting time in thromboelastometry
It represents the time to start forming clot and initial fibrin formation
Measured: 8 hours
Clot formation time in thromboelastometry
It represents the clot strengthening and rapidity of fibrin build up
Measured: 8 hours
Maximum clot firmness in thromboelastometry
It represents the highest vertical amplitude of the thromboelastometry graph and represents clot strength
Measured: 8 hours
LI30 in thromboelastometry
It represents clot breakdown and fibrinolysis at fixed time
Measured: 8 hours
Control of bleeding at 48 hours
The investigators would measure the hemoglobin levels to see for any drop in concentration of hemoglobin
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Jul 2021
- Primary completion8 Jan 2022
- Study completion8 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NIMI GOPAL, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333510
- Sponsor's protocol ID
- IEC/2021/86/MA06
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Premkumar M, Saxena P, Rangegowda D, Baweja S, Mirza R, Jain P, Bhatia P, Kumar G, Bihari C, Kalal C, Vyas T, Choudhury A, Sarin SK. Coagulation failure is associated with bleeding events and clinical outcome during systemic inflammatory response and sepsis in acute-on-chronic liver failure: An observational cohort study. Liver Int. 2019 Apr;39(4):694-704. doi: 10.1111/liv.14034. Epub 2019 Feb 7.
PubMed 30589495Kumar 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 31148204Wikkelso A, Wetterslev J, Moller AM, Afshari A. Thromboelastography (TEG) or thromboelastometry (ROTEM) to monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database Syst Rev. 2016 Aug 22;2016(8):CD007871. doi: 10.1002/14651858.CD007871.pub3.
PubMed 27552162Singh SA, Krishnan G, Ashraf H, Subramanian R, Pandey V, Nasa VK, Goyal S, Gupta S. Correlation between thromboelastography and rotational thromboelastometry values in adult liver transplant recipients. Indian J Anaesth. 2020 Apr;64(4):286-291. doi: 10.4103/ija.IJA_762_19. Epub 2020 Mar 28.
PubMed 32489202
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Thromboelastography Versus Thromboelastometry for Coagulopathy Correction in Patients of Liver Cirrhosis With Non Variceal Bleed- Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05333510
- Acronym / sponsor ID
- IEC/2021/86/MA06
- Conditions
- Liver Cirrhosis
- Keywords
- THROMBOELASTOGRAPHY, THROMBOELASTOMETRY, nonvariceal, bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 19 Apr 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.
Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited.
Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients.
In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding
Detailed description
Thromboelastography (TEG) and thromboelastometry( ROTEM) are point-of-care, global hemostasis assessment tests that measure the viscoelastic changes that occur during the hemostatic process.
Patients with cirrhosis have an imbalance of procoagulants and anticoagulants combined with alterations in fibrinolysis ,platelet number and function.
Point of care viscoelastic tests (TEG ,ROTEM) demonstrate specific functional coagulation defects that can direct blood component transfusion therapy in cirrhosis, with clinical validation of individual parameters.
Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited.
Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients.
In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEG group | – | –Thromboelastography guided blood product administration in patients of liver cirrhosis with non variceal bleed |
| ROTEM group | – | –Throboelastometry guided blood product administration in patients of liver cirrhosis with non variceal bleed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of liver cirrhosis who are presenting with non variceal bleed would be included in this study
Key inclusion criteria (1 listed)
- patients of liver cirrhosis with non variceal bleed
Key exclusion criteria (5 listed)
- Pregnant and postpartum patients
- died within the first 24hours of admission.
- variceal and postvariceal ligation ulcer bleed.
- On anticoagulants or antiplatelets at the time of admission in ICU
- Transfusion with blood products before admission to the ICU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured
Time frame: 8 hours
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured
10 secondary outcomes
R time of thromboelastography
Time frame: 8 hours
K time of thromboelastography
Time frame: 8 hours
alpha angle of thromboelastography
Time frame: 8 hours
Maximum amplitude of thromboleastography
Time frame: 8 hours
LY30 Iin thromboelastometry
Time frame: 8 hours
Clotting time in thromboelastometry
Time frame: 8 hours
Clot formation time in thromboelastometry
Time frame: 8 hours
Maximum clot firmness in thromboelastometry
Time frame: 8 hours
LI30 in thromboelastometry
Time frame: 8 hours
Control of bleeding at 48 hours
Time frame: 48 hours
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 19 Apr 2022.
- Background: PubMed 30589495Premkumar M, Saxena P, Rangegowda D, Baweja S, Mirza R, Jain P, Bhatia P, Kumar G, Bihari C, Kalal C, Vyas T, Choudhury A, Sarin SK. Coagulation failure is associated with bleeding events and clinical outcome during systemic inflammatory response and sepsis in acute-on-chronic liver failure: An observational cohort study. Liver Int. 2019 Apr;39(4):694-704. doi: 10.1111/liv.14034. Epub 2019 Feb 7.
- 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.
- Background: PubMed 27552162Wikkelso A, Wetterslev J, Moller AM, Afshari A. Thromboelastography (TEG) or thromboelastometry (ROTEM) to monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database Syst Rev. 2016 Aug 22;2016(8):CD007871. doi: 10.1002/14651858.CD007871.pub3.
- Background: PubMed 32489202Singh SA, Krishnan G, Ashraf H, Subramanian R, Pandey V, Nasa VK, Goyal S, Gupta S. Correlation between thromboelastography and rotational thromboelastometry values in adult liver transplant recipients. Indian J Anaesth. 2020 Apr;64(4):286-291. doi: 10.4103/ija.IJA_762_19. Epub 2020 Mar 28.
- Individual participant dataSharing planned: No
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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.
NIMI GOPAL principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India 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 1 inclusion and 5 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 19 Apr 2022. 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?
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured (time frame: 8 hours). 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 NCT05333510, which also lists 4 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 19 Apr 2022.