Sickle Cell CrisisSCIENCENCT05373771
Sickle Cell Improvement: Enhancing Care in the Emergency Department
A study testing Care pathway in people with Sickle Cell Crisis, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black. The disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Sickle Cell Crisis
- What is being tested?
- Care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,328 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ED visit for uncomplicated pain crisis
- Sickle cell disease
- Receipt of at least one opioid
Who cannot join
- Acute chest syndrome
- Fever > 38.5 in the ED
- priapism
- sickle cell trait
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Wisconsin
Milwaukee, Wisconsin, 53226
David Brousseau
About this study
Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black. The disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality of life. The National Heart, Lung and Blood Institute, as well as the American Society of Hematology, have endorsed pain management guidelines regarding the timeliness of care for children presenting with these acute pain crises. These evidence-based guidelines are infrequently followed, resulting in increased pain and hospitalizations. In additional to other barriers to following the guideline, structural racism has been proposed as a significant contributor and the New England Journal of Medicine recently called for the institution of SCD-specific pain management protocols to combat structural racism and reduce time to opioid administration. The investigators' long-term goal is to improve the care and health outcomes of children with acute painful vaso-occlusive crisis treated in the emergency department. The overall aim of the investigators is to test a care pathway using multifaceted implementation strategies to increase guideline adherent care for children in the emergency department with acute painful vaso-occlusive crisis.
- Conditions
- Sickle Cell Crisis
- Being tested
- Care pathway
- Medical subject headings
- Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care pathwayOther
Implementation of care pathway as part of hybrid type 2 implementation effectiveness study
| Study group | Role | What they receive |
|---|---|---|
| Post-intervention | Active comparator | Not described Receives: Other: Care pathway |
| Delayed intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeliness of receipt of opioids
The percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose
Measured: A maximum of about 6 hours as all opioids received during the ED stay will be captured
Secondary outcomes (2)
Median time to opioids
Median time from arrival to first opioid and then subsequent opioids
Measured: A maximum of about 6 hours as all opioids received during the ED stay will be captured
Percent of children hospitalized
Disposition of hospitalization or discharge home
Measured: A maximum of about 6 hours as that is the typical maximum time to disposition for patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Sep 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell CrisisStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5,328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Emergency Care Applied Research Network, Nemours Children's Health System
- Responsible party
- Principal investigator, David Brousseau, Nemours Children's Health System
- Investigators
- David Brousseau, MD, MS, Principal investigator, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373771
- Sponsor's protocol ID
- 00114249
- Acronym
- SCIENCE
- Status last verified
- Aug 2023
- First submitted
- 5 May 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Outcome data gathered through central data Registry. It is a limited dataset. A public use dataset will be made available after the study consistent with NIH guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Improvement: Enhancing Care in the Emergency Department
- ClinicalTrials.gov ID
- NCT05373771
- Acronym / sponsor ID
- SCIENCE / 00114249
- Conditions
- Sickle Cell Crisis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,328 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Pediatric Emergency Care Applied Research Network, Nemours Children's Health System
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black. The disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality of life. The National Heart, Lung and Blood Institute, as well as the American Society of Hematology, have endorsed pain management guidelines regarding the timeliness of care for children presenting with these acute pain crises. These evidence-based guidelines are infrequently followed, resulting in increased pain and hospitalizations. In additional to other barriers to following the guideline, structural racism has been proposed as a significant contributor and the New England Journal of Medicine recently called for the institution of SCD-specific pain management protocols to combat structural racism and reduce time to opioid administration. The investigators' long-term goal is to improve the care and health outcomes of children with acute painful vaso-occlusive crisis treated in the emergency department. The overall aim of the investigators is to test a care pathway using multifaceted implementation strategies to increase guideline adherent care for children in the emergency department with acute painful vaso-occlusive crisis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-intervention | Active comparator | Other: Care pathway |
| Delayed intervention | No intervention | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ED visit for uncomplicated pain crisis
- Sickle cell disease
- Receipt of at least one opioid
Key exclusion criteria (4 listed)
- Acute chest syndrome
- Fever > 38.5 in the ED
- priapism
- sickle cell trait
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care pathwayImplementation of care pathway as part of hybrid type 2 implementation effectiveness study | Other | Post-intervention |
Primary outcome
Timeliness of receipt of opioids
Time frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured
The percent of patients who receive first dose of opioids within 60 minutes of arrival and subsequent doses within 30 minutes of previous dose
2 secondary outcomes
Median time to opioids
Time frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured
Percent of children hospitalized
Time frame: A maximum of about 6 hours as that is the typical maximum time to disposition for patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No. Outcome data gathered through central data Registry. It is a limited dataset. A public use dataset will be made available after the study consistent with NIH guidelines.
Related trials for Sickle Cell Crisis
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
RecruitingPhase 2
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sickle Cell Disease
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
Active, not recruitingObservational study
Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
Sickle Cell Anemia, Sickle Cell Thalassemia
RecruitingObservational study
Natural History of Sickle Cell Disease
Pain Crisis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Brousseau, MD, MS principal investigator
Nemours Children's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care pathway in people with Sickle Cell Crisis, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Brousseau, MD, MS ((302) 651-4000, david.brousseau@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeliness of receipt of opioids (time frame: A maximum of about 6 hours as all opioids received during the ED stay will be captured). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.