TriangleNCT03398200 · OUTCOME
Time From Transplant to Neutrophil Count Recovery
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 100 days
What was measured
Time from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count \>=0.5 thou/ul after nadir.
Groups in this outcome
Hyperbaric Oxygen Therapy
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
No Hyperbaric Oxygen Therapy
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
| Group | Source count |
|---|---|
| Hyperbaric Oxygen Therapy | 52 |
| No Hyperbaric Oxygen Therapy | 46 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | 12 | Not reported | 12 | 13 | Not reported |
| No Hyperbaric Oxygen Therapy | 12 | Not reported | 12 | 13 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.89
- statistical Comment
- 1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.89
- statistical Comment
- 1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12
- upper Limit
- 13
- value
- 12
- group Id
- OG001
- lower Limit
- 12
- upper Limit
- 13
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 46
- units
- Participants
- description
- Time from transplant to neutrophil recovery was measured as the first day of absolute neutrophil count \>=0.5 thou/ul after nadir.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion. Hyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
- id
- OG000
- title
- Hyperbaric Oxygen Therapy
- description
- Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion. No Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
- id
- OG001
- title
- No Hyperbaric Oxygen Therapy
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- 100 days
- title
- Time From Transplant to Neutrophil Count Recovery
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice