Effect of two drugs(granulocyte colony stimulating factor and erythropoietin combination) on bleeding from the upper gastrointestinal tract with underlying liver disease

Effect of Granulocyte-colony stimulating factor and erythropoietin combination therapy on survival in patients of upper gastrointestinal bleed with underlying cirrhosis of liver: a parallel arm closed label randomized control trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032466

Enrollment

Registered

2021-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Granulocyte colony stimulating factor(G-CSF) and erythropoeitin(EPO) combination therapy: Inj GSF 5mcg/kg subcutaneous on day 1,2,3,4,5 and then every third day till day 28(total 12 dos

Eligibility

Inclusion criteria

Inclusion criteria: Patients above 18 years of age being evaluated for upper gastrointestinal bleed with underlying liver cirrhosis in the department of surgery, JIPMER

Exclusion criteria

Exclusion criteria: Age 75 years, suspected autoimmune hepatitis,hepatocellular carcinoma, any focus of sepsis,multi- organ dysfunction, grade 3 or 4 hepatic encephalopathy, HIV seropositivity, pregnancy, uncontrolled hypertension, coronary artery disease,planned for liver transplantation, refusal to participate in the study

Design outcomes

Primary

Measure	Time frame
To compare the overall survival at 1 year follow up in the two groupsTimepoint: At 1 year	—

Secondary

Measure	Time frame
Change in AFP levelsTimepoint: 1st month and 12th month;Change in ARFI scan scoreTimepoint: 1st month,6th month,12th month;Change in liver disease severity scoresTimepoint: 1st month,6th month,12th month;Development of new onset complicationsTimepoint: Monthly;Number of rebleeding episodesTimepoint: Over 1 year;Safety of the therapyTimepoint: Daily for 1 month	—

Countries

India

Contacts

Public ContactAishwarya R

JIPMER, Puducherry

pikachooa@gmail.com7838964296

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026