Comparing Individualized vs. Weight Based Protocols to Treat VOE in SCD Occlusive Episodes in Sickle Cell Disease (COMPARE-VOE)

• ClinicalTrials.gov Identifier: NCT03933397
• Recruitment Status: Terminated
• First Posted: May 1, 2019
• Last Update Posted: May 27, 2022
• Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: April 29, 2019
• First Posted Date: May 1, 2019
• Last Update Posted Date: May 27, 2022
• Actual Study Start Date: August 6, 2019
• Actual Primary Completion Date: May 13, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 29, 2019)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 29, 2019)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparing Individualized vs. Weight Based Protocols to Treat VOE in SCD Occlusive Episodes in Sickle Cell Disease
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Sickle Cell Disease

Intervention

• 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.
• 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

Study Arms

• 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.
  Interventions:

  • Other: Patient-Specific Protocol
  • Drug: Morphine
  • Drug: Hydromorphone
• Experimental: Weight-based Protocol
  Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
  Interventions:

  • Other: Weight-based Protocol
  • Drug: Morphine
  • Drug: Hydromorphone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 24, 2022): 329
• Original Estimated Enrollment (submitted: April 29, 2019): 460
• Actual Study Completion Date: May 20, 2022
• Actual Primary Completion Date: May 13, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03933397
• Other Study ID Numbers: Pro00101245; 1U24HL137907-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: 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

• PRS Account: Duke University
• Verification Date: May 2022