Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease

PHASE3TerminatedINTERVENTIONAL
Enrollment

328

Participants

Timeline

Start Date

August 13, 2019

Primary Completion Date

May 13, 2022

Study Completion Date

May 20, 2022

Conditions
Sickle Cell Disease
Interventions
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%.

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%.

Trial Locations (6)

21201

University of Maryland, Baltimore

28204

Atrium Health, Charlotte

44106

Case Western University, Cleveland

48202

Henry Ford Health System, Detroit

Wayne State University, Detroit

75390

University of Texas Southwestern Medical Center, Dallas

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Duke University

OTHER

NCT03933397 - Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease | Biotech Hunter | Biotech Hunter