Health Condition 1: D695- Secondary thrombocytopenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for CIT groups 1. Male or female aged between 18-65 years. 2. Subjects willing to sign an informed consent with date prior to participation in the trial. 3. Patients with confirmed solid tumor and received at least one cycle of chemotherapy prior to screening visit. 4. Patients with a platelet counts between > 40000 and Inclusion criteria For Prophylaxis group: 1. Male or female aged between 18-65 years. 2. Subjects willing to sign an informed consent with date prior to participation in the trial. 3. Patients with confirmed solid tumor and received at least one cycle of chemotherapy prior to screening visit and with history of CIT during any previous cycle of chemotherapy
Exclusion criteria
Exclusion criteria: Exclusion Criteria for CIT groups 1. Pregnant or lactating women. 2. Subjects planning to receive any type of surgery. 3. Patients with platelet count less than 30000/ml. 4. Patients with thrombocytopenia presenting with active bleeding. 5. Patients who have received blood or blood product transfusion during the current illness or during past one week. 6. Patients with thrombocytopenia purpura (ITP) leukemia, hemophilia or bleeding diathesis. 7. Participation in another trial with another investigational product Exclusion criteria For Prophylaxis group: 1.Planning to receive any type of surgery. 2. Pregnant or lactating women. 3. Patients with thrombocytopenia presenting with active bleeding. 4. Patients who have received blood or blood product transfusion during the current illness or during past one week. 5. Patients with thrombocytopenia purpura (ITP) leukemia, hemophilia or bleeding diathesis. 6. Participation in another trial with another investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in platelet count after chemotherapy % reduction in number of CIT cases as compared to previous cycleTimepoint: days 0, 7, 10 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Hb%, TLC, DLC, Bilirubin, SGOT SGPT, ALP, Urea, Creatinine Timepoint: Days 0, 7, & 14 | — |
Countries
India
Contacts
AIIMS