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Analyzing the requirements of platelets transfusion in stem cell transplant and high dose chemotherapy patients by giving with or without romiplostim.

Open labelled, randomized, controlled trial of romiplostim for reducing rejection and platelet transfusions in autologous and allogeneic hematopoietic stem cell transplantation (HSCT) and High dose chemotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038468
Enrollment
196
Registered
2021-12-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: D708- Other neutropenia

Interventions

Intervention1: romiplostim: 5-10 mcg perkg perweek, till platelets are greater than 50000. duration once weekly till platelets greater than 50000, route sub cutaneous, frequency once a week Control In

Sponsors

Dr Sachin Suresh Jadhav
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: all patients undergoing autologous. allogenic HSCT and high dose chemotherapy in our department.

Exclusion criteria

Exclusion criteria: Myelofibrosis (Reticulin for collagen fibrosis >2), any prior history of thromboembolic events.

Design outcomes

Primary

MeasureTime frame
Primary outcome: 1) Number of platelet transfusions until engraftment. 2) Number of days platelet count below 30,000 for patient undergoing Number of days platelet count below 30,000 for patient undergoing high dose chemotherapy 3) Number of platelet transfusion until day +30 and +100 Timepoint: time point weekly once—

Secondary

MeasureTime frame
1)Day of Neutrophil engraftment 2) Day of platelet engraftment 3) Graft rejection: Chimerism at Day 28,60,100,6 month and Day 365 4) Secondary failure of platelet recovery (SFPR): defined as a decline of platelets counts 20 multiplies 10000000000 per L for 7 consecutive days or requiring transfusion support after achieving sustained platelet count greater than or equal 50 multiplies 10000000000 per litre without transfusions for 7 consecutive days after hematopoietic stem cell transplantation.Timepoint: 3 years—

Countries

India

Contacts

Public ContactDr Sachin Suresh Jadhav

HCG Cancer Hospital, bangalore

drsachinjadhav@hotmail.com9741351357

Outcome results

None listed

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