Comparing Individualized vs. Weight Based Protocols to Treat VOE in SCD Occlusive Episodes in Sickle Cell Disease (COMPARE-VOE)
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| ClinicalTrials.gov Identifier: NCT03933397 |
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Recruitment Status :
Terminated
(Due to COVID enrollment numbers needed to meet the primary endpoint will not be met.)
First Posted : May 1, 2019
Last Update Posted : May 27, 2022
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Sponsor:
Duke University
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 329 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 |
| Actual Primary Completion Date : | May 13, 2022 |
| Actual Study Completion Date : | May 20, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Sickle cell disease
MedlinePlus related topics:
Body Weight
| Arm | Intervention/treatment |
|---|---|
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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.
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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 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%.
Other Name: Morphine Sulfate Drug: Hydromorphone 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%.
Other Name: Dilaudid |
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Experimental: Weight-based Protocol
Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
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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 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%.
Other Name: Morphine Sulfate Drug: Hydromorphone 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%.
Other Name: Dilaudid |
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 ]
Information from the National Library of Medicine
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| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933397
Locations
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| Wayne State University | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Atrium Health | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Case Western University | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
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 |
Study Documents (Full-Text)
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT03933397 |
| Other Study ID Numbers: |
Pro00101245 1U24HL137907-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 1, 2019 Key Record Dates |
| Last Update Posted: | May 27, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Morphine |
Hydromorphone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |