Impact of splenectomies on hematopoietic stem cell transplantation outcomes of pediatric transfusion dependent thalassemia (TDT) patients

Completed

• Conditions: Transfusion dependent thalassemiasplenectomyhematopoietic stem cell transplantation; splenectomy; HSCT; pediatric; TDT; outcome

• Registration Number: TCTR20191205004
• Lead Sponsor: one

Brief Summary

Although splenectomies prior toHSCT for the TDT patients in our cohort were associated with faster neutrophil engraftments and lower rejection rates, they did not produce significantly better OS or affect the mortality. As the splenectomies did not provide any distinct advantages, this procedure should not be routinely performed as a pre-HSCT regimen for TDT patients with splenomegaly.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-06-30
• Study Start: 2019-12-05
• Results First Posted: 2020-06-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Transfusion dependent thalassemia patients who underwent HLA-matched, related HSCTs at the Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand, from August 1st, 1987 to December 31st, 2014.

Exclusion Criteria

Transfusion dependent thalassemia patients who underwent HLA-mismatched or unrelated HSCTs at the Department of Pediatrics, Faculty of Medicine Siriraj Hospital

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival 5-year from the date of HSCT extract data from medical records, record data in SPSS program, analyze data using A Kaplanâ€Meyer

Secondary Outcome Measures

Name	Time	Method
mortality rate, rejection rate, and engraftment time date of dead, rejection, and engraftment after the date of HSCT extract data from medical records, record data in SPSS program, analyze data using The Mannâ€Whitne