Trial · NCT01425307

Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea

NCT01425307, Phase 3, Terminated, Children's Hospital Medical Center, Cincinnati; results first posted 2017-04-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea. Trials, record NCT01425307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01425307

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea
NCT number: NCT01425307
Status: Terminated
Phases: Phase 3
Enrollment: 159 participants, actual
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Sickle Cell Anemia
Interventions: Hydroxyurea
First posted: 2011-08-30
Last updated: 2020-07-22
Results first posted: 2017-04-11
Limitations and caveats: Further analysis is required to verify that the Adverse Events are accurately represented.

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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).	Intention-to-Treat	cm/sec	MEAN
SECONDARY	TCD Time-averaged Mean Velocity on the Non-index Side	24 months
SECONDARY	Primary Stroke Events	24 months
SECONDARY	Non-stroke Neurological Events	24 months
SECONDARY	Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin	Baseline and 24 months		ng per mL	MEAN
SECONDARY	Effects on Quality of Life	24 months
SECONDARY	Functional Status	24 months
SECONDARY	Neuropsychological Decline	24 months
SECONDARY	Growth and Development	24 months
SECONDARY	Number of Participants With Transfusion Events	24 months

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side	Treatment Arm	138	95% Confidence Interval 135 to 142	cm/sec
Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side	Standard Therapy	143	95% Confidence Interval 140 to 146	cm/sec
Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin	Standard Therapy	-38	Standard Deviation 2095	ng per mL
Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin	Treatment Arm	-1805	Standard Deviation 1651	ng per mL
Change of Baseline in Hepatic Iron Overload as Assessed by Liver Iron Concentration	Standard Therapy	2.4	Standard Deviation 8.7	mg FE per g dry weight liver
Change of Baseline in Hepatic Iron Overload as Assessed by Liver Iron Concentration	Treatment Arm	-1.9	Standard Deviation 4.2	mg FE per g dry weight liver

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Therapy	61
Overall Study	STARTED	Treatment Arm	60
Overall Study	COMPLETED	Standard Therapy	42
Overall Study	COMPLETED	Treatment Arm	41
Overall Study	NOT COMPLETED	Standard Therapy	19
Overall Study	NOT COMPLETED	Treatment Arm	19

Source ClinicalTrials.gov

Adverse events100

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Sickle Cell Anemia with Crisis	Blood and lymphatic system disorders	Standard Therapy	9	61	28
other	Sickle Cell Anemia with Crisis	Blood and lymphatic system disorders	Treatment Arm	24	60	62
other	Abdominal Pain	Gastrointestinal disorders	Standard Therapy	7	61	12
other	Abdominal Pain	Gastrointestinal disorders	Treatment Arm	6	60	7
other	Abdominal Pain Upper	Gastrointestinal disorders	Standard Therapy	3	61	3
other	Abdominal Pain Upper	Gastrointestinal disorders	Treatment Arm	3	60	4
other	Constipation	Gastrointestinal disorders	Standard Therapy	0	61	0
other	Constipation	Gastrointestinal disorders	Treatment Arm	4	60	6
other	Gastritis	Gastrointestinal disorders	Standard Therapy	3	61	4
other	Gastritis	Gastrointestinal disorders	Treatment Arm	0	60	0

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Therapy
Total, all-cause mortality	Treatment Arm
Total, other adverse events	Standard Therapy	53	61
Total, other adverse events	Treatment Arm	58	60
Total, serious adverse events	Standard Therapy	6	61
Total, serious adverse events	Treatment Arm	9	60

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26670617	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL095647	TCD With Transfusions Changing to Hydroxyurea	WARE, RUSSELL E	CINCINNATI CHILDRENS HOSP MED CTR	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2009 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Standard Therapy vs Treatment Arm: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01425307

GET https://conductscience.org/api/trials/v1/NCT01425307/events?page=2

API reference For AI assistants