Sickle-Cell Disease With CrisisNCT05388188
DSUVIA in Patients With SCD VOC Present in the ED
An observational study of Sickle-Cell Disease With Crisis, run by Jason Wilson at 1 site in United States.
Trial summary
This is an observational study to improve the treatment of patients with Sickle Cell Disease Vaso-Occlusive Crisis by administering pain medications more quickly after the patient arrives in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle-Cell Disease With Crisis
- What is being tested?
- sublingual sufentanil
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with known sickle cell disease that present to the ED with a SCD VOC
Who may be able to join
- Age >= 18
- Known history/self-reported history of Sickle Cell Disease
- Participant has self-described sickle cell related pain
- Patient has attempted to utilize oral opioid pain medications in the last 24 hours
Who cannot join
- Unable to provide informed consent to participate in the study, such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
- Participant has a temperature of > 100.4 F
- Participant has heart rate > 120
- Participant has systolic blood pressure < 90
- Clinical provider or investigator states that patient has "Acute Chest Syndrome"
- Participant unlikely to comply with protocol as determined by Investigator
Show all 10Show fewer
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study
- Persistent significant or severe infection, either acute or chronic
- No prior oral opioid use for SCD VOC pain control
- Participation in this study within the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Ashley Barnes, RN, 813-660-6035, ashleybarnes@tgh.org
About this study
Official title: Throughput and Disposition Metrics When Using Dsuvia as a Bridging Medication to Decrease Time to Analgesia and Hospital Admissions in Patients With Sickle Cell Disease Vaso-Occlusive Crisis That Present to the Emergency Department
This is an observational study to improve the treatment of patients with Sickle Cell Disease Vaso-Occlusive Crisis by administering pain medications more quickly after the patient arrives in the emergency department. Specifically, we are using a sublingual opioid called sufentanil [Dsuvia] that has already been approved by the Food and Drug Administration (FDA) for the treatment of acute pain. It is being studied as part of this research study to find out if we can relieve the patients pain more quickly and decrease the amount of time the patient needs to spend in the hospital by avoiding a hospital admission after the patients emergency department encounter if the patients pain is adequately controlled.
Read the detailed description
Patients with SCD VOC may present to the ED after oral home medications fail to relieve acute pain. Patients with SCD VOC may require parenteral analgesia for pain relief but, upon arrival to the ED these patients often undergo long wait times until receiving first parenteral medication dose. Oral opioid pain medications are not adequate as most adult patients with SCD and history of SCD VOC have already tried utilizing oral opioids out of the hospital. Intravenous access is challenging in this population with venous scarring or central ports that require sterile access. The need to establish IV access and to, eventually, provide parenteral opioids results in long delays in the time to first dose of drug (time to analgesia) in patients with SCD VOC that present to the ED. Delays in analgesia increase the likelihood of hospital admission in patients with SCD VOC that present to the ED. Patients with SCD VOC that are admitted to the hospital often have a long LOS. A bridge medication or intervention is needed for patients with SCD VOC upon entry into the ED that provides adequate and timely analgesia. In 2020, our ED began utilizing Dsuvia in patients with SCD VOC as a bridging medication. Data has not been collected to specifically examine the impact of Dsuvia use on patient throughput metrics and disposition.
Use of Dsuvia in ED patients with SCD VOC will decrease door to first analgesic time (time to analgesia). Decrease of door to first analgesic time will decrease the overall admission rate for patients with SCD VOC without decreasing patient or staff satisfaction. Use of STL Dsuvia will not lead to an increase in adverse patient safety events. Patients that receive Dsuvia early in the ED encounter may also require a lower overall amount of opioids, represented by morphine milligram equivalents (MME) than patients in a historical control group that did not receive Dsuvia. In addition, this study extends evidence for efficacy of Dsuvia in patients with acute pain but a history of opioid tolerance (unlike prior studies with Dsuvia that excluded patients with opioid tolerance). Since 2020, our ED standard of care for patients with SCD VOC is to utilize Dsuvia as early as possible in the ED course.
- Conditions
- Sickle-Cell Disease With Crisis
- Being tested
- sublingual sufentanil
- Keywords
- Sickle Cell Disease, SCD, SCD VOC
- Medical subject headings
- Vaso-Occlusive Crises, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual sufentanilDrug
Also called Dsuvia Sublingual Product
Dsuvia in patients with SCD VOC as a bridging medication.
| Study group | Role | What they receive |
|---|---|---|
| Sickle Cell Disease Vaso-Occlusive (SCD VOC) crisis | Adult patients with known sickle cell disease present in the ED with a SCD VOC and ED provider has ordered as part of the patient's standard of care, sublingual opioid called sufentanil [Dsuvia] (a strong pain medicine that dissolves under your tongue) for the patient. Receives: Drug: sublingual sufentanil | |
| Historical Sample | collection of retrospective data of SCD VOC patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Analgesia
pain onset to inability to feel pain
Measured: 1 hour
Secondary outcomes (2)
Time at Hospital
Length of time in the ED and/or length of stay in the hospital
Measured: through study completion, an average of 1 week
Measurement of morphine milligram equivalents (MME)
Total MME in patients receiving Dsuvia during ED encounter
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start30 Mar 2022
- Primary completionApr 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle-Cell Disease With CrisisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Wilson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jason Wilson, Tampa General Hospital
- Investigators
- Jason Wilson, MD, Principal investigator, Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388188
- Sponsor's protocol ID
- 20-0412
- Status last verified
- May 2022
- First submitted
- 17 Apr 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Throughput and Disposition Metrics When Using Dsuvia as a Bridging Medication to Decrease Time to Analgesia and Hospital Admissions in Patients With Sickle Cell Disease Vaso-Occlusive Crisis That Present to the Emergency Department
- ClinicalTrials.gov ID
- NCT05388188
- Acronym / sponsor ID
- 20-0412
- Conditions
- Sickle-Cell Disease With Crisis
- Keywords
- Sickle Cell Disease, SCD, SCD VOC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jason WilsonUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 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.
This is an observational study to improve the treatment of patients with Sickle Cell Disease Vaso-Occlusive Crisis by administering pain medications more quickly after the patient arrives in the emergency department. Specifically, we are using a sublingual opioid called sufentanil [Dsuvia] that has already been approved by the Food and Drug Administration (FDA) for the treatment of acute pain. It is being studied as part of this research study to find out if we can relieve the patients pain more quickly and decrease the amount of time the patient needs to spend in the hospital by avoiding a hospital admission after the patients emergency department encounter if the patients pain is adequately controlled.
Detailed description
Patients with SCD VOC may present to the ED after oral home medications fail to relieve acute pain. Patients with SCD VOC may require parenteral analgesia for pain relief but, upon arrival to the ED these patients often undergo long wait times until receiving first parenteral medication dose. Oral opioid pain medications are not adequate as most adult patients with SCD and history of SCD VOC have already tried utilizing oral opioids out of the hospital. Intravenous access is challenging in this population with venous scarring or central ports that require sterile access. The need to establish IV access and to, eventually, provide parenteral opioids results in long delays in the time to first dose of drug (time to analgesia) in patients with SCD VOC that present to the ED. Delays in analgesia increase the likelihood of hospital admission in patients with SCD VOC that present to the ED. Patients with SCD VOC that are admitted to the hospital often have a long LOS. A bridge medication or intervention is needed for patients with SCD VOC upon entry into the ED that provides adequate and timely analgesia. In 2020, our ED began utilizing Dsuvia in patients with SCD VOC as a bridging medication. Data has not been collected to specifically examine the impact of Dsuvia use on patient throughput metrics and disposition.
Use of Dsuvia in ED patients with SCD VOC will decrease door to first analgesic time (time to analgesia). Decrease of door to first analgesic time will decrease the overall admission rate for patients with SCD VOC without decreasing patient or staff satisfaction. Use of STL Dsuvia will not lead to an increase in adverse patient safety events. Patients that receive Dsuvia early in the ED encounter may also require a lower overall amount of opioids, represented by morphine milligram equivalents (MME) than patients in a historical control group that did not receive Dsuvia. In addition, this study extends evidence for efficacy of Dsuvia in patients with acute pain but a history of opioid tolerance (unlike prior studies with Dsuvia that excluded patients with opioid tolerance). Since 2020, our ED standard of care for patients with SCD VOC is to utilize Dsuvia as early as possible in the ED course.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Disease Vaso-Occlusive (SCD VOC) crisis | – | Drug: sublingual sufentanilAdult patients with known sickle cell disease present in the ED with a SCD VOC and ED provider has ordered as part of the patient's standard of care, sublingual opioid called sufentanil [Dsuvia] (a strong pain medicine that dissolves under your tongue) for the patient. |
| Historical Sample | – | –collection of retrospective data of SCD VOC patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with known sickle cell disease that present to the ED with a SCD VOC
Key inclusion criteria (4 listed)
- Age >= 18
- Known history/self-reported history of Sickle Cell Disease
- Participant has self-described sickle cell related pain
- Patient has attempted to utilize oral opioid pain medications in the last 24 hours
Key exclusion criteria (10 listed)
- Unable to provide informed consent to participate in the study, such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
- Participant has a temperature of > 100.4 F
- Participant has heart rate > 120
- Participant has systolic blood pressure < 90
- Clinical provider or investigator states that patient has "Acute Chest Syndrome"
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 |
|---|---|---|
| sublingual sufentanilAlso: Dsuvia Sublingual ProductDsuvia in patients with SCD VOC as a bridging medication. | Drug | Sickle Cell Disease Vaso-Occlusive (SCD VOC) crisis |
Primary outcome
Time to Analgesia
Time frame: 1 hour
pain onset to inability to feel pain
2 secondary outcomes
Time at Hospital
Time frame: through study completion, an average of 1 week
Measurement of morphine milligram equivalents (MME)
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
Related trials for Sickle-Cell Disease With 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
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
Sickle Cell Disease
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. This study is not recruiting at the moment.
Jason Wilson, MD principal investigator
Tampa General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle-Cell Disease With Crisis, run by Jason Wilson 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashley Barnes, RN (813-660-6035, ashleynbarnes@tgh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Analgesia (time frame: 1 hour). 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 24 May 2022.