Coagulation DisorderNCT04111120
Heparin Like Effect in Acute Variceal Bleeding
An observational study of Coagulation Disorder and Cirrhosis, Liver, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
This study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation Disorder, Cirrhosis, Liver, Variceal Hemorrhage
- What is being tested?
- SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2019to Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cirrhosis with acute variceal bleeding
Who may be able to join
- Age 18-65 years
- Cirrhosis with acute variceal bleeding.
Who cannot join
- Patients with evidence of sepsis at presentation.
- 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
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- 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, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh, Choose Any State/Province, 160012
Madhumita Premkumar
About this study
Official title: Assessment of Coagulation Profile and Role of Endogenous Heparinoids in SIRS and Sepsis in Acute Variceal Bleeding in Cirrhosis
This study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.
Thromboelastography (TEG) /Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with cirrhosis who present with acute variceal bleeding, will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and thrombin generation response swill be assessed. Thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.
- Conditions
- Coagulation Disorder, Cirrhosis, Liver, Variceal Hemorrhage
- Being tested
- SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI
- Keywords
- thromboelastography, variceal bleeding
- Medical subject headings
- Hemostatic Disorders, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAIDiagnostic test
Coagulation assessment using heparinase treated SONOCLOT
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis with variceal bleeding | Coagulation factor assays and heparinase treated SONOCLOT at Days 0,3, and 7 Receives: Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI | |
| Cirrhosis without Bleeding | Control group of 25 subjects Receives: Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of Endogenous Heparinoids
Change in SONOCLOT values- global and heparinase treated
Measured: 7 days
Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI
Specific factor assessment
Measured: 7 days
Secondary outcomes (1)
Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization
blood transfusion requirements
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Nov 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coagulation DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- RK Dhiman, MD DM, Study chair, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111120
- Sponsor's protocol ID
- INT/IEC/2019/001615
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Premkumar M, Mehtani R, Kulkarni AV, Duseja AK, De A, Taneja S, Singh V, Verma N, Ahluwalia J, Kajal K, Divyaveer S, Roy A, Gandotra A, Kalson N, Kekan K, Kaur H, Kaur H. Association of Heparin-Like Effect, Factor VII/XIII Deficiency and Fibrinolysis with Rebleeding Risk in Cirrhosis with Acute Variceal Bleeding. Dig Dis Sci. 2023 Feb;68(2):497-513. doi: 10.1007/s10620-022-07656-9. Epub 2022 Aug 19.
PubMed 35984611
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coagulation Profile and Role of Endogenous Heparinoids in SIRS and Sepsis in Acute Variceal Bleeding in Cirrhosis
- ClinicalTrials.gov ID
- NCT04111120
- Acronym / sponsor ID
- INT/IEC/2019/001615
- Conditions
- Coagulation Disorder, Cirrhosis, Liver, Variceal Hemorrhage
- Keywords
- thromboelastography, variceal bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Oct 2019 (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.
This study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.
Thromboelastography (TEG) /Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with cirrhosis who present with acute variceal bleeding, will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and thrombin generation response swill be assessed. Thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis with variceal bleeding | – | Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAICoagulation factor assays and heparinase treated SONOCLOT at Days 0,3, and 7 |
| Cirrhosis without Bleeding | – | Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAIControl group of 25 subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhosis with acute variceal bleeding
Key inclusion criteria (2 listed)
- Age 18-65 years
- Cirrhosis with acute variceal bleeding.
Key exclusion criteria (9 listed)
- Patients with evidence of sepsis at presentation.
- 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
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 |
|---|---|---|
| SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAICoagulation assessment using heparinase treated SONOCLOT | Diagnostic test | Cirrhosis with variceal bleeding, Cirrhosis without Bleeding |
Primary outcome
Generation of Endogenous Heparinoids
Time frame: 7 days
Change in SONOCLOT values- global and heparinase treated
Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI
Time frame: 7 days
Specific factor assessment
1 secondary outcome
Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization
Time frame: 7 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 35984611Premkumar M, Mehtani R, Kulkarni AV, Duseja AK, De A, Taneja S, Singh V, Verma N, Ahluwalia J, Kajal K, Divyaveer S, Roy A, Gandotra A, Kalson N, Kekan K, Kaur H, Kaur H. Association of Heparin-Like Effect, Factor VII/XIII Deficiency and Fibrinolysis with Rebleeding Risk in Cirrhosis with Acute Variceal Bleeding. Dig Dis Sci. 2023 Feb;68(2):497-513. doi: 10.1007/s10620-022-07656-9. Epub 2022 Aug 19.
- 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.
RK Dhiman, MD DM study chair
Post Graduate Institute of Medical Education and Research, Chandigarh
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 Coagulation Disorder and Cirrhosis, Liver, 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 2 inclusion and 9 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 28 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madhumita Premkumar, MD DM (01722756344, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of Endogenous Heparinoids (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT04111120, which also lists 1 linked publication.
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 28 Sep 2021.