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

Sickle Cell Disease Clinical Trial

— COMPARE-VOE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03933397
• Other study ID #: Pro00101245
• Secondary ID: 1U24HL137907-01A
• Status: Terminated
• Phase: Phase 3
• Start date: August 13, 2019
• Est. completion date: May 20, 2022

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 328
• Est. completion date: May 20, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• 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.
• 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%.
• 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%.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Atrium Health	Charlotte	North Carolina
United States	Case Western University	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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