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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
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

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

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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


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




Primary Outcome Measures :
  1. 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 :
  1. Average length of study in the emergency department [ Time Frame: Up to 6 hours ]
  2. Number of return ED visits within the next 7 days [ Time Frame: up to 7 days ]
  3. 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


Contacts
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Contact: Beth Martinez 919-608-8094 beth.martinez@duke.edu

Locations
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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 Not yet 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: Simone Trotman    980-442-2538    simone.trotman@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 Not yet 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
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Principal Investigator: Huiman Barnhart, PhD Duke University
Principal Investigator: Paula Tanabe, PhD Duke University School of Nursing

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03933397     History of Changes
Other Study ID Numbers: Pro00101245
1U24HL137907-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Hematologic Diseases
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Morphine
Hydromorphone
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents