High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation
Status:
Completed
Trial end date:
2020-08-10
Target enrollment:
Participant gender:
Summary
Purpose: To conduct a randomized controlled pilot study investigating the use of high dose
intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium,
including health-related quality of life (HRQOL), functional status, and neuropsychiatric
outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic
hematopoietic stem cell transplant (HSCT).
Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for
allogeneic stem cell transplant.
Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after
transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will
be measured weekly and participants will be assessed for evidence of delirium using validated
measures. Validated measures will also be used to assess cognitive function, depression,
post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at
one, three, and six months after transplant.
Phase:
Phase 2
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center University of North Carolina, Chapel Hill