Trial · NCT01425307
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side | Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months). | The primary endpoint for the TWiTCH trial was the difference between the treatment groups of the maximum TCD TAMV on the index side, calculated from a mixed model. The index side is the side with the higher mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the TAMV on the index site were obtained at clinic visits during baseline and during the treatment period. |
| Secondary | TCD Time-averaged Mean Velocity on the Non-index Side | 24 months | This secondary endpoint for the TWiTCH trial will be maximum TCD time-averaged mean velocity on the non-index side. The non-index side is the side with the lower mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the secondary endpoint will be obtained at clinic visits during baseline and during the 24-month treatment period. |
| Secondary | Primary Stroke Events | 24 months | This secondary outcome measure will compare standard to alternative therapy for primary stroke events (a) primary ischemic stroke; b) primary hemorrhagic stroke |
| Secondary | Non-stroke Neurological Events | 24 months | This secondary objective will compare standard to alternative treatment for the incidence of non-stroke neurological events. Data for this outcome will be collected through entry and exit neurological exams. |
| Secondary | Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin | Baseline and 24 months | This secondary objective will compare standard to alternative therapy for hepatic iron overload. |
| Secondary | Effects on Quality of Life | 24 months | Standard Quality of Life measure will be taken during specific time points as well as one newly developed Sickle Cell Disease-specific test. |
| Secondary | Functional Status | 24 months | This outcome will be measured using Barthel Index testing at the beginning, middle, and end of the treatment period. |
| Secondary | Neuropsychological Decline | 24 months | This outcome will be measured using standardized neurocognitive tests at baseline and exit. |
| Secondary | Growth and Development | 24 months | This outcome will be measured by capturing height and weight monthly and conducting an annual pubertal assessment. |
| Secondary | Number of Participants With Transfusion Events | 24 months | This outcome will be recorded on every interval visit form through questions asking whether there have been transfusion complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE. |
| Secondary | Number of Participants With Hydroxyurea Toxicities | 24 Months | This measure will be performed on a monthly basis throughout the trial by recording the CBC and retic count. |
| Secondary | Number of Participants With Phlebotomy Complications | 24 months | This outcome will be recorded on every interval visit form through questions asking whether there have been phlebotomy complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE. |
| Secondary | Number of Participants With Liver MRI Complications | 24 months | This outcome will be recorded through questions asking whether there have been Liver MRI complications at baseline, middle, and end of treatment. Any complication higher than a CTCAE grade 2 event will be reported as a SAE. |
| Secondary | Number of Participants With Serious Adverse Events | 24 Months | |
| Secondary | Change of Baseline in Hepatic Iron Overload as Assessed by Liver Iron Concentration | Baseline and 24 months | This secondary objective will compare standard to alternative therapy for hepatic iron overload. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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