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

NCT03933397 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: Pro001012451U24HL137907-01A1
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 6

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• The Change in Pain Score

  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.

  baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first

Secondary Outcomes (4)

• Length of Index ED (Emergency Department) Stay

  From bed placement to discharge or 6 hours whichever comes first

• Length of Care

  up to 6 hours

• Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment

  Up to 7 days post enrollment

• Number of Participants Experiencing Side Effects

  Bed placement to discharge or 6 hours, whichever comes first

Study Arms (2)

Patient-Specific Protocol

EXPERIMENTAL

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; Drug: Morphine; Drug: Hydromorphone

Weight-based Protocol

EXPERIMENTAL

Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.

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

Interventions

Patient-Specific Protocol OTHER

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.

Patient-Specific Protocol

Weight-based Protocol OTHER

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.

Weight-based Protocol

Morphine DRUG

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%.

Also known as: Morphine Sulfate

Patient-Specific Protocol; Weight-based Protocol

Hydromorphone DRUG

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%.

Also known as: Dilaudid

Patient-Specific Protocol; Weight-based Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (6)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Case Western University

Cleveland, Ohio, 44106, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Morphine; Hydromorphone

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Huiman Barnhardt, PhD
• Organization: Duke Clinical Research Institute - Duke University Medical Center

huiman.barnhart@duke.edu

919-668-7313

Study Officials

• Huiman Barnhart, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Paula Tanabe, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: August 13, 2019
• Primary Completion: May 13, 2022
• Study Completion: May 20, 2022
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)