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

Phase 3

Terminated

• Conditions: Sickle Cell Disease
• Interventions: Other: Patient-Specific Protocol; Other: Weight-based Protocol; Drug: Morphine; Drug: Hydromorphone

• Registration Number: NCT03933397
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-01
• Study Start: 2019-08-13
• Primary Completion: 2022-05-13
• Study Completion: 2022-05-20
• Results First Submitted: 2023-05-05
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Results First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

• All adult (18 years or older);
• Sickle Cell Disease patients with the following genotypes: Hgb SS (sickle cell anemia), SC(Sickle hemoglobin-c) , and SB+(sickle Beta-Plus thalassemia) and SB-(sickle Beta zero thalassemia)

Exclusion Criteria

• determined to not benefit from opioids and therefore won't receive opioids in any future Emergency Department visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient-Specific Protocol	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.
Weight-based Protocol	Weight-based Protocol	Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
Patient-Specific Protocol	Morphine	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.
Weight-based Protocol	Morphine	Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.
Patient-Specific Protocol	Hydromorphone	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.
Weight-based Protocol	Hydromorphone	Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.

Primary Outcome Measures

Name	Time	Method
The Change in Pain Score	baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first	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. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a vision and verbal score if possible collecting the visual score first. For the analysis, the visual score was used if available for the primary outcome. if not available, the verbal score was used.

Secondary Outcome Measures

Name	Time	Method
Length of Index ED (Emergency Department) Stay	From bed placement to discharge or 6 hours whichever comes first	Length of index ED stay in hours from bed placement to discharge
Length of Care	up to 6 hours	Length of care from bed placement to last drug dose in hours.
Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment	Up to 7 days post enrollment	Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment
Number of Participants Experiencing Side Effects	Bed placement to discharge or 6 hours, whichever comes first	Side effects and safety at any time during the emergency department visit

Trial Locations

Locations (6)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Case Western University; 🇺🇸 Cleveland, Ohio, United States