Sickle Cell DiseasePhase 3COMPARE-VOENCT03933397
Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
A Phase 3 study testing Patient-Specific Protocol, Weight-based Protocol and Morphine in people with Sickle Cell Disease, run by Duke University at 6 sites in United States.
Trial summary
The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while 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
- What is being tested?
- Patient-Specific Protocol, Weight-based Protocol and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Aug 2019to 20 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- All adult (18 years or older);
- Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and SB-(sickle Beta zero thalassemia)
Who cannot join
- determined to not benefit from opioids and therefore won't receive opioids in any future Emergency Department visit.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland
Baltimore, Maryland, 21201
Atrium Health
Charlotte, North Carolina, 28204
Case Western University
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
Wayne State University
Detroit, Michigan, 48202
About this study
Official title: A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.
- Conditions
- Sickle Cell Disease
- Being tested
- Patient-Specific Protocol, Weight-based Protocol, Morphine, Hydromorphone
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Specific ProtocolOther
Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home for pain and what was needed during their past hospital and emergency department visits to treat pain. Medicines will include opioids, either morphine or hydromorphone. A member of the outpatient SCD provider team will review the patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective and safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours.
Weight-based ProtocolOther
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team.
MorphineDrug
Also called Morphine Sulfate
4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
HydromorphoneDrug
Also called Dilaudid
1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Specific Protocol | Experimental | Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home, what was needed during their past hospital and emergency department visits to treat pain and doses that have been effective and safe in the past. Receives: Other: Patient-Specific Protocol; Drug: Morphine; Drug: Hydromorphone |
| Weight-based Protocol | Experimental | Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Receives: Other: Weight-based Protocol; Drug: Morphine; Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Pain Score
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.
Measured: baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first
Secondary outcomes (4)
Length of Index ED (Emergency Department) Stay
Length of index ED stay in hours from bed placement to discharge
Measured: From bed placement to discharge or 6 hours whichever comes first
Length of Care
Length of care from bed placement to last drug dose in hours.
Measured: up to 6 hours
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment
Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment
Measured: Up to 7 days post enrollment
Number of Participants Experiencing Side Effects
Side effects and safety at any time during the emergency department visit
Measured: Bed placement to discharge or 6 hours, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start13 Aug 2019
- Primary completion13 May 2022
- Study completion20 May 2022
Why it stopped: Due to COVID enrollment numbers needed to meet the primary endpoint will not be met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Huiman Barnhart, PhD, Principal investigator, Duke UniversityPaula Tanabe, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933397
- Sponsor's protocol ID
- Pro00101245
- Other IDs
- 1U24HL137907-01A1
- Acronym
- COMPARE-VOE
- Status last verified
- Jun 2023
- First submitted
- 29 Apr 2019
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knisely MR, Barnhart HX, Ibemere SO, Kavanagh P, Paice JA, Strouse JJ, Tanabe PJ. Comparison of Measures of Pain Intensity During Sickle Cell Disease Vaso-Occlusive Episodes. J Pain. 2024 Dec;25(12):104658. doi: 10.1016/j.jpain.2024.104658. Epub 2024 Aug 21.
PubMed 39154808
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03933397
- Acronym / sponsor ID
- COMPARE-VOE / Pro00101245
- Conditions
- Sickle Cell Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID enrollment numbers needed to meet the primary endpoint will not be met.
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Specific Protocol | Experimental | Other: Patient-Specific Protocol, Drug: Morphine, Drug: HydromorphonePatients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home, what was needed during their past hospital and emergency department visits to treat pain and doses that have been effective and safe in the past. |
| Weight-based Protocol | Experimental | Other: Weight-based Protocol, Drug: Morphine, Drug: HydromorphonePatients assigned to this treatment protocol will be given pain medicine(s) based on their weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult (18 years or older);
- Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and SB-(sickle Beta zero thalassemia)
Key exclusion criteria (1 listed)
- determined to not benefit from opioids and therefore won't receive opioids in any future Emergency Department visit.
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 |
|---|---|---|
| Patient-Specific ProtocolPatients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home for pain and what was needed during their past hospital and emergency department visits to treat pain. Medicines will include opioids, either morphine or hydromorphone. A member of the outpatient SCD provider team will review the patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective and safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours. | Other | Patient-Specific Protocol |
| Weight-based ProtocolPatients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team. | Other | Weight-based Protocol |
| MorphineAlso: Morphine Sulfate4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. | Drug | Patient-Specific Protocol, Weight-based Protocol |
| HydromorphoneAlso: Dilaudid1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%. | Drug | Patient-Specific Protocol, Weight-based Protocol |
Primary outcome
The Change in Pain Score
Time frame: 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.
4 secondary outcomes
Length of Index ED (Emergency Department) Stay
Time frame: From bed placement to discharge or 6 hours whichever comes first
Length of Care
Time frame: up to 6 hours
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment
Time frame: Up to 7 days post enrollment
Number of Participants Experiencing Side Effects
Time frame: Bed placement to discharge or 6 hours, whichever comes first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39154808Knisely MR, Barnhart HX, Ibemere SO, Kavanagh P, Paice JA, Strouse JJ, Tanabe PJ. Comparison of Measures of Pain Intensity During Sickle Cell Disease Vaso-Occlusive Episodes. J Pain. 2024 Dec;25(12):104658. doi: 10.1016/j.jpain.2024.104658. Epub 2024 Aug 21.
- Individual participant dataSharing planned: No
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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.
Huiman Barnhart, PhD principal investigator
Duke University
Paula Tanabe, PhD principal investigator
Duke University School of Nursing
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Patient-Specific Protocol, Weight-based Protocol and Morphine in people with Sickle Cell Disease, run by Duke University at 6 sites 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in Pain Score (time frame: baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933397, which also lists 1 linked publication.
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 3 Jul 2023.