| CTRI Number |
CTRI/2018/02/012230 [Registered on: 28/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
New treatment for cardiac abnormalities in cirrhosis |
|
Scientific Title of Study
|
Assessment of Coagulation Profile and Haematopoietic Responses in Patients With Acute-on-chronic Liver Failure During Systemic Inflammatory Response (SIRS) and Sepsis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT02307409 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhumita |
| Designation |
Senior Resident, Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
ILBS
D-1, Vasant Kunj
New Delhi
New Delhi
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
drmadhumitap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Kumar Sarin |
| Designation |
Senior Professor, Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No 1042, First Floor,
D-1, Vasant Kunj
New Delhi
New Delhi
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
shivsarin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhumita |
| Designation |
Senior Resident, Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Institute of Liver and Biliary Sciences,
D-1, Vasant Kunj,
New Delhi.
South
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
drmadhumitap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences,
D-1,Vasant Kunj
New Delhi-110070 |
|
|
Primary Sponsor
|
| Name |
Institute of liver and Biliary Sciences |
| Address |
D-1, Vasant Kunj
New Delhi |
| Type of Sponsor |
Other [Government Hospital] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhumita |
Institute of Liver and Biliary Sciences |
Department of Hepatology,
Room No 1042,1st Floor,
D-1, Vasant Kunj
New Delhi
DELHI |
01146300000
01146300025
drmadhumitap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute-on-chronic Liver Failure During Systemic Inflammatory Response (SIRS) and Sepsis , (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sonoclot/TEG test in Decompensated Chronic Liver Disease |
The Sonoclot/TEG test will be done at the study time points. Within 12 hours of presentation in the emergency department, at 72 hours, and at 7 days, or when the patient meets the study criteria for suspected or proven sepsis |
| Comparator Agent |
Sonoclot/TEG test in healthy controls |
The Sonoclot/TEG test will be done at the study time points. Within 12 hours of presentation in the emergency department, at 72 hours, and at 7 days, or when the patient meets the study criteria for suspected or proven sepsis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Age 18-65 years
2)ACLF (Acute on Chronic Liver Failure), as diagnosed by APASL (Asian Pacific association of Study of Liver Disease) criteria mentioned above.
|
|
| ExclusionCriteria |
| Details |
1)Patients with evidence of sepsis at presentation.
2)Current therapy: Recent blood or blood component transfusion in the last 2 days.
3)HIV positive/ AIDS patients
4)Patients requiring anti platelet therapy,
5)Renal insufficiency requiring dialysis
6)Active malignancy within the last 5 years
7)Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease
8)Administration of anticoagulants, antifibrinolytics,
9)Not willing to participate in the study
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence and severity of coagulation profile derangement and haematopoietic responses, by sonoclot/ TEG, coagulation and hematological parameters, in acute- on-chronic liver failure with and without systemic inflammatory response. |
0 day, 3 day and 7 day after admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Utility of sonoclot/ TEG in predicting blood product utilization. |
0 day, 3 day and 7 day after admission |
| Sonoclot/TEG result indicating hypocoagulability correlates with the patients tendency to bleed in ACLF |
0 day, 3 day and 7 day after admission |
| Changes in baseline coagulation profile can predict development of sepsis in patients of ACLF. |
0 day, 3 day and 7 day after admission |
| Coagulation dysfunction (prothrombotic and anticoagulant tendencies) in patients with ACLF with or without evidence of sepsis. |
0 day, 3 day and 7 day after admission |
| Effect of sepsis on the haematopoietic response of patients with Acute on Chronic Liver Failure. |
0 day, 3 day and 7 day after admission |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2014 |
| Date of Study Completion (India) |
01/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
"None yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dynamic coagulation derangements, measured by thromboelastography, determine the likelihood of bleeding, sepsis and mortality in ACLF (Acute on Chronic Liver Failure). |