Phase 2
N=64
High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation
Hematopoietic Stem Cell Transplantation · Delirium · Thiamine Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT03263442 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Percentage of Participants With Delirium — 25; 21 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thiamine (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Delirium |
25; 21 | — |
| SECONDARY Delirium Severity |
4.0; 4.0; 4.83; 4.67; 6.50; 5.33 | — |
| SECONDARY Delirium Duration |
2.0; 4.4 | — |
| SECONDARY Concentration of Thiamine Status Stratified by Delirium Status |
115.6; 93.8 | — |
| SECONDARY Change in Health-related Quality of Life Scores (Month 1) |
-7.53; -5.69 | — |
| SECONDARY Change in Health-related Quality of Life Scores (Month 3) |
-3.96; -1.43 | — |
| SECONDARY Change in Health-related Quality of Life Scores (Month 6) |
-4.36; 0.28 | — |
| SECONDARY Change in Depression Scores (Month 1) |
-1.34; 1.16 | — |
| SECONDARY Change in Depression Scores (Month 3) |
0.93; 0.32 | — |
| SECONDARY Change in Depression Scores (Month 6) |
0.14; -1.66 | — |
| SECONDARY Change in Post-traumatic Stress Symptom Scores (Month 1) |
-0.52; 1.55 | — |
| SECONDARY Change in Post-traumatic Stress Symptom Scores (Month 3) |
-1.50; 0.83 | — |
| SECONDARY Change in Post-traumatic Stress Symptom Scores (Month 6) |
1.79; 1.32 | — |
| SECONDARY Change in Cognitive Function Scores (Month 1) |
-0.70; -0.09 | — |
| SECONDARY Change in Cognitive Function Scores (Month 3) |
-0.12; 0.97 | — |
| SECONDARY Change in Cognitive Function Scores (Month 6) |
0.71; 1.54 | — |
| SECONDARY Change in Functional Status Scores (Month 1) |
0.70; 0.88 | — |
| SECONDARY Change in Functional Status Scores (Month 3) |
0.69; 0.60 | — |
| SECONDARY Change in Functional Status Scores (Month 6) |
0.46; 0.21 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03263442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.