High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation

Delirium is a common and potentially preventable neuropsychiatric complication in cancer
patients receiving hematopoietic stem cell transplantation (HSCT) that has profound
consequences. Among cancer patients hospitalized for HSCT, delirium occurs in approximately
40% of patients and increases the risk of mortality. Long-term, delirium in this population
results in worse physical health, mental health, and quality of life. Though strategies to
prevent delirium have the potential to significantly improve the lives of people living with
cancer, research in this area is extremely limited. Thiamine deficiency is also ubiquitous
during HSCT and a known contributor to the development of delirium in other patient
populations. High dose intravenous (IV) thiamine is an evidence-based and promising treatment
for delirium, but no one has studied IV thiamine as a prevention strategy.

This is a randomized double-blind controlled trial in participants undergoing allogeneic HSCT
to determine if high dose IV thiamine can prevent delirium and minimize the deleterious
impact of delirium on health-related quality of life (HRQOL), functional status, and other
neuropsychiatric outcomes. The investigators will recruit 60 patients admitted for allogeneic
HSCT at UNC, randomize them to treatment with high dose IV thiamine (n = 30) versus placebo
(n = 30), and systematically evaluate all participants for delirium and related
comorbidities. The investigators will use the Delirium Rating Scale (DRS) to measure the
severity and duration of delirium immediately prior to transplant and after HSCT until 30
days post-transplant or discharge. If delirium is identified, the DRS will be administered
daily until delirium resolves. The investigators will obtain thiamine levels and other
laboratory parameters associated with delirium the day after transplant, and continue to
monitor thiamine levels weekly thereafter. The investigators will also monitor HRQOL,
functional status, depression, post-traumatic stress symptoms, and cognitive function prior
to transplant and at one, three, and six months after transplant to elucidate the persistent
impact of delirium in this population and the potential for thiamine to mitigate these
negative outcomes.

Inclusion Criteria:

- Admission to the UNC Hospital Bone Marrow Transplant Unit for allogeneic stem cell
transplant

- At least 18 years of age

- Able to speak English

- Able to provide informed consent

Exclusion Criteria:

- A history of adverse reaction to IV thiamine

- Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment