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出境医 / 临床实验 / Comparing Individualized vs. Weight Based Protocols to Treat VOE in SCD Occlusive Episodes in Sickle Cell Disease (COMPARE-VOE)
Comparing Individualized vs. Weight Based Protocols to Treat VOE in SCD Occlusive Episodes in Sickle Cell Disease (COMPARE-VOE)
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sickle Cell Disease | Other: Patient-Specific Protocol Other: Weight-based Protocol Drug: Morphine Drug: Hydromorphone | Phase 3 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 460 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease |
| Actual Study Start Date : | August 6, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | January 7, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Patient-Specific Protocol
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.
|
Other: Patient-Specific Protocol
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.
Drug: Morphine 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%.
Other Name: Morphine Sulfate
Drug: Hydromorphone 1 mg for participants weighing 50-69.9 kgs, 1.25 mg for participants weighing 60 - 69.9 kgs, 1.5 mg for participants weighing 70-89.9 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%.
Other Name: Dilaudid
|
|
Experimental: Weight-based Protocol
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
|
Other: Weight-based Protocol
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.
Drug: Morphine 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%.
Other Name: Morphine Sulfate
Drug: Hydromorphone 1 mg for participants weighing 50-69.9 kgs, 1.25 mg for participants weighing 60 - 69.9 kgs, 1.5 mg for participants weighing 70-89.9 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%.
Other Name: Dilaudid
|
Outcome Measures
Primary Outcome Measures :
- Change in pain scores as measured by patient reported pain level. [ Time Frame: baseline (hospital admission), up to 6 hours (hospital discharge) ]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.
Secondary Outcome Measures :
- Average length of study in the emergency department [ Time Frame: Up to 6 hours ]
- Number of return ED visits within the next 7 days [ Time Frame: up to 7 days ]
- Number of hospitalizations for Vaso- Occlusive Episode (VOE) within the next 7 days [ Time Frame: Up to 7 days ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All adult (18 years or older);
- SCD patients with the following genotypes: Hgb SS, SC, and SB+ and SB- thalassemia
Exclusion Criteria:
- determined to not benefit from opioids and therefore won't receive opioids in any future ED visit.
Contacts and Locations
Contacts
| Contact: Beth Martinez | 919-608-8094 | beth.martinez@duke.edu |
Locations
| United States, Maryland | |
| University of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Dana Beach, RN 410-328-7635 dbeach3@som.umaryland.edu | |
| Principal Investigator: Richard WIlkerson, MD | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Kathleen Wilson, RN 313-916-9551 kwilso10@hfhs.org | |
| Principal Investigator: Joseph Miller, MD | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Tom Mazzocco, RN 313-993-8464 tmazzocco@wayne.edu | |
| Principal Investigator: James Paxton, MD | |
| United States, North Carolina | |
| Atrium Health | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Maria Zapata 980-442-2538 maria.zapata@atriumhealth.org | |
| Principal Investigator: Ifeyinwa osunkwo, MD | |
| United States, Ohio | |
| Case Western University | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Erica Denallo 216-286-7453 erica.denallo@UHhospitals.org | |
| Principal Investigator: Christopher Miller, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Riley Martin 214-648-9980 riley.martin@utsouthwestern.edu | |
| Principal Investigator: Ava Pierce, MD | |
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Huiman Barnhart, PhD | Duke University | |
| Principal Investigator: | Paula Tanabe, PhD | Duke University School of Nursing |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||||
| First Posted Date ICMJE | May 1, 2019 | ||||||
| Last Update Posted Date | August 7, 2020 | ||||||
| Actual Study Start Date ICMJE | August 6, 2019 | ||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Change in pain scores as measured by patient reported pain level. [ Time Frame: baseline (hospital admission), up to 6 hours (hospital discharge) ] 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Comparing Individualized vs. Weight Based Protocols to Treat VOE in SCD Occlusive Episodes in Sickle Cell Disease | ||||||
| Official Title ICMJE | A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease | ||||||
| Brief 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. 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment |
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| Condition ICMJE | Sickle Cell Disease | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
460 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | January 7, 2022 | ||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03933397 | ||||||
| Other Study ID Numbers ICMJE | Pro00101245 1U24HL137907-01A1 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Duke University | ||||||
| Study Sponsor ICMJE | Duke University | ||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||
| Investigators ICMJE |
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| PRS Account | Duke University | ||||||
| Verification Date | August 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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