Home » Trials » SLCTR/2018/015
The Effect of granulocyte colony-stimulating factor and erythropoietin on survival in patients with Acute-on-Chronic Liver Failure
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SLCTR Registration Number
SLCTR/2018/015
Date of Registration
The date of last modification
Aug 24, 2019
Scientific Title of Trial
The Effect of granulocyte colony-stimulating factor and erythropoietin on survival in patients with Acute-on-Chronic Liver Failure
Public Title of Trial
The Effect of granulocyte colony-stimulating factor and erythropoietin on survival in patients with Acute-on-Chronic Liver Failure.
Disease or Health Condition(s) Studied
Acute-on-Chronic Liver Failure.
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1212-4931
Any other number(s) assigned to the trial and issuing authority
BSMMU/2017/12508 (IRB: Bangabandhu Sheikh Mujib Medical University)
What is the research question being addressed?
Does the combination of granulocyte colony-stimulating factor and erythropoietin therapy improve survival of patients with Acute-on-Chronic Liver Failure?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Phase 4
Intervention(s) planned
Study setting: The patient with Acute-on-Chronic Liver Failure will be admitted into the Department of Hepatology at Bangabandhu Sheikh Mujib Medical University, Dhaka. Patients will be allocated into 2 groups using simple randomization.
Group A will be receive standard medical treatment (supportive treatment like intravenous albumin, antibiotics, anti-virals and treatment of complications like variceal bleeding, hepato-renal syndrome,spontaneous bacterial peritonitis etc according to standard guidelines).
Group B will receive add on treatment with granulocyte colony-stimulating factor and erythropoietin. Granulocyte colony-stimulating factor will be administered at a dose of 5µg/Kg/day, subcutaneously, for six days along with subcutaneous Erythropoietin (40 mcg/wk) for a total of 4 weeks. Standard medical therapy will be provided as for Group A.
Inclusion criteria
• Age:>18 years
• Sex: both sexes
• Bilirubin > 5 mg/dl
• Coagulopathy (international normalized ratio > 1.5)
• Complicated by clinical ascites and/or encephalopathy within 4 weeks
• Patient with previously diagnosed or undiagnosed chronic liver disease
• Acute insult caused by reactivation of HBV, HBV Flare, HEV,HAV or any aetiology
Exclusion criteria
• Age <18 years
• Decompensated Cirrhosis
• Coexistent hepatocellular carcinoma (HCC)
• Patients on immune-modulator or cytotoxic/immunosuppressive therapy
• Co morbidity like heart failure, any malignancy and uncontrolled diabetic patients
.
• Any previous known hypersensitivity to G-CSF and EPO
• Patients unwilling to take part in the study
Primary outcome(s)
|
1.
Change in MELD score (Model for end stage liver disease) |
[ At baseline and 90 days ] |
|
2.
Change in CTP (Child-Turcotte-Pugh) score |
[ At baseline and 90 days ] |
|
3.
Survival |
[ At 90 days ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
36 (18 in each arm)
Countries of recruitment
Bangladesh
Anticipated start date
2018-06-01
Anticipated end date
2019-04-01
Date of first enrollment
2018-07-06
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-11-04
Approval number
BSMMU/2017/12508
Details of Ethics Review Committee
| Name: | Institutional Review Board, Bangabandhu Sheikh Mujib Medical University |
| Institutional Address: | Shahbag, Dhaka, Bangladesh |
| Telephone: | +880-8612550 |
| Email: | registrar@bsmmu.edu.bd |
Contact person for Scientific Queries/Principal Investigator
Dr. Md. Nazmul Haque
MD Student
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Mob: 01719976961
dr.nazmulhaquermc@gmail.com
Contact Person for Public Queries
Dr. Md. Ayub Al Mamun
Associate Professor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Mob: 01712091867
ayubmamunal@gmail.com
Primary study sponsor/organization
Dr. Md. Nazmul Haque
MD Student
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Mob: 01719976961
dr.nazmulhaquermc@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
