Trial · NCT03933397

Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease

NCT03933397, Phase 3, Terminated, Duke University; results first posted 2023-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease. Trials, record NCT03933397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03933397

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Trial

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

Title: Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
NCT number: NCT03933397
Status: Terminated
Phases: Phase 3
Enrollment: 328 participants, actual
Lead sponsor: Duke University
Conditions: Sickle Cell Disease
Interventions: Patient-Specific Protocol, Weight-based Protocol, Morphine, Hydromorphone
First posted: 2019-05-01
Last updated: 2023-07-03
Results first posted: 2023-07-03

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	The Change in Pain Score	baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first	Pain is measured by having the patient mark pain on a scale of 0 to 100, with 0 being no pain and 100 being the worst pain ever. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a vision and verbal score if possible collecting the visual score first. For the analysis, the visual score was used if available for the primary outcome. if not available, the verbal score was used.
Secondary	Length of Index ED (Emergency Department) Stay	From bed placement to discharge or 6 hours whichever comes first	Length of index ED stay in hours from bed placement to discharge
Secondary	Length of Care	up to 6 hours	Length of care from bed placement to last drug dose in hours.
Secondary	Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment	Up to 7 days post enrollment	Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment
Secondary	Number of Participants Experiencing Side Effects	Bed placement to discharge or 6 hours, whichever comes first	Side effects and safety at any time during the emergency department visit

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Change in Pain Score	baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first	3 participants were excluded following COVID-19 diagnosis, 5 participants had missing data following baseline so analysis could not be made.	score on a scale	MEAN
SECONDARY	Length of Index ED (Emergency Department) Stay	From bed placement to discharge or 6 hours whichever comes first	Patients had to be placed in bed in emergency department. Time was calculated from placement to change in disposition or at the end of 6 hours whichever came first.	hours	MEAN
SECONDARY	Length of Care	up to 6 hours	Data not collected on 10 participants	hours	MEAN
SECONDARY	Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment	Up to 7 days post enrollment		hospitalizations	NUMBER
SECONDARY	Number of Participants Experiencing Side Effects	Bed placement to discharge or 6 hours, whichever comes first		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Spread	Units
The Change in Pain Score	Patient-Specific Protocol		-27.0	Standard Deviation 27.54	score on a scale
The Change in Pain Score	Weight-based Protocol		-27.6	Standard Deviation 28.13	score on a scale
Length of Index ED (Emergency Department) Stay	Patient-Specific Protocol		3.4	Standard Deviation 1.48	hours
Length of Index ED (Emergency Department) Stay	Weight-based Protocol		4.2	Standard Deviation 1.72	hours
Length of Care	Patient-Specific Protocol		2.5	Standard Deviation 1.46	hours
Length of Care	Weight-based Protocol		2.6	Standard Deviation 1.62	hours
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment	Patient-Specific Protocol		11		hospitalizations
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment	Weight-based Protocol		14		hospitalizations
Number of Participants Experiencing Side Effects	Patient-Specific Protocol	Nausea	19		Participants
Number of Participants Experiencing Side Effects	Weight-based Protocol	Nausea	19		Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Patient-Specific Protocol	162
Overall Study	STARTED	Weight-based Protocol	166
Overall Study	COMPLETED	Patient-Specific Protocol	50
Overall Study	COMPLETED	Weight-based Protocol	46
Overall Study	NOT COMPLETED	Patient-Specific Protocol	112
Overall Study	NOT COMPLETED	Weight-based Protocol	120

Source ClinicalTrials.gov

Adverse events16

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	nausea	General disorders	Patient-Specific Protocol	19	50	19
other	nausea	General disorders	Weight-based Protocol	19	46	19
other	vomiting	General disorders	Patient-Specific Protocol	7	50	7
other	vomiting	General disorders	Weight-based Protocol	6	46	6
other	Pruritus	Skin and subcutaneous tissue disorders	Patient-Specific Protocol	31	50	31
other	Pruritus	Skin and subcutaneous tissue disorders	Weight-based Protocol	36	46	36
other	SPO2<95%	Respiratory, thoracic and mediastinal disorders	Patient-Specific Protocol	4	50	4
other	SPO2<95%	Respiratory, thoracic and mediastinal disorders	Weight-based Protocol	7	46	7
other	Moderate to severe sedation	General disorders	Patient-Specific Protocol	4	50	4
other	Moderate to severe sedation	General disorders	Weight-based Protocol	5	46	5

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Patient-Specific Protocol	0	50
Total, all-cause mortality	Weight-based Protocol	0	46
Total, other adverse events	Patient-Specific Protocol	50	50
Total, other adverse events	Weight-based Protocol	46	46
Total, serious adverse events	Patient-Specific Protocol	0	50
Total, serious adverse events	Weight-based Protocol	0	46

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39154808	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
U24HL137907	2/2 A comparison of individualized vs. weight based protocols to treat vaso-occlusive episodes in Sickle Cell Disease (COMPARE VOE)	BARNHART, HUIMAN X	DUKE UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2018 to 2021

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Patient-Specific Protocol vs Weight-based Protocol: deaths from any cause	Trial comparisons
Patient-Specific Protocol vs Weight-based Protocol: serious adverse events	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.

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