18 and older, any sex, with Hematopoietic Stem Cell Transplantation or Delirium. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With DeliriumPrimary· Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.
Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of \> 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium incidence will be defined as at
Group
Value
95% CI
Intervention
25
Control
21
Delirium SeveritySecondary· Assessments will occur in the week prior to transplant (baseline), then at least 3 times post-transplant on a weekly basis until 30 days post-transplant or discharge, whichever comes first, up to week 5
Delirium severity will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The score ranges from 0 to 32 with higher scores reflecting more severe symptoms. A cut-off score of \> 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. The DRS medians and ranges are report
Baseline
Group
Value
95% CI
Intervention
4.0
2.0 – 8.0
Control
4.0
2.0 – 7.0
Week 1
Group
Value
95% CI
Intervention
4.83
3.0 – 9.0
Control
4.67
2.67 – 15.00
Week 2
Group
Value
95% CI
Intervention
6.50
2.67 – 20.33
Control
5.33
2.33 – 16.00
Week 3
Group
Value
95% CI
Intervention
6.33
1.00 – 18.60
Control
5.17
2.00 – 17.80
Week 4
Group
Value
95% CI
Intervention
5.50
4.00 – 20.00
Control
6.00
5.00 – 13.50
Week 5
Group
Value
95% CI
Intervention
20.00
20.00 – 20.00
Control
7.50
4.00 – 8.00
Delirium DurationSecondary· Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.
Delirium duration will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of \> 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium duration will be reported as num
Group
Value
95% CI
Intervention
2.0
± 1.2
Control
4.4
± 4.7
Concentration of Thiamine Status Stratified by Delirium StatusSecondary· From end of 7-day intervention period until the development of delirium at any point during the post-transplant hospitalization up to a maximum of 30 days
The relationship between thiamine levels at the end of the seven day administration of thiamine and the development of delirium at any point during the thirty days post-transplant or the post-transplant hospitalization, whichever comes first, will be examined. Thiamine levels (nmol/L) are presented in participants who did and did not experience delirium.
Group
Value
95% CI
Delirium
115.6
± 69.3
No Delirium
93.8
± 28.5
Change in Health-related Quality of Life Scores (Month 1)Secondary· From baseline to one month post-transplant
HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.
Group
Value
95% CI
Intervention
-7.53
± 11.66
Control
-5.69
± 11.59
Change in Health-related Quality of Life Scores (Month 3)Secondary· Baseline to three months post-transplant
HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.
Group
Value
95% CI
Intervention
-3.96
± 9.11
Control
-1.43
± 16.79
Change in Health-related Quality of Life Scores (Month 6)Secondary· Baseline to six months post-transplant
HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.
Group
Value
95% CI
Intervention
-4.36
± 14.09
Control
0.28
± 12.17
Change in Depression Scores (Month 1)Secondary· Baseline to one month post-transplant
Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.
Group
Value
95% CI
Intervention
-1.34
± 8.28
Control
1.16
± 6.12
Change in Depression Scores (Month 3)Secondary· Baseline to three months post-transplant
Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.
Group
Value
95% CI
Intervention
0.93
± 6.24
Control
0.32
± 9.53
Change in Depression Scores (Month 6)Secondary· Baseline to six months post-transplant
Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.
Group
Value
95% CI
Intervention
0.14
± 6.88
Control
-1.66
± 7.89
Change in Post-traumatic Stress Symptom Scores (Month 1)Secondary· Baseline to one month post-transplant
Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.
Group
Value
95% CI
Intervention
-0.52
± 10.88
Control
1.55
± 6.92
Change in Post-traumatic Stress Symptom Scores (Month 3)Secondary· Baseline to three months post-transplant
Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.
Group
Value
95% CI
Intervention
-1.50
± 6.58
Control
0.83
± 5.63
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT03509662 — Vitamin C in Post-cardiac Arrest
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 19 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03263442.