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

Duke University

Status and phase: Terminated; Phase 3

Conditions: Sickle Cell Disease

Treatments: Other: Patient-Specific Protocol; Other: Weight-based Protocol; Drug: Morphine; Drug: Hydromorphone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03933397

Pro00101245

1U24HL137907-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

Patient-Specific Protocol

Experimental group

Description:

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.

Treatment:

Other: Patient-Specific Protocol

Drug: Morphine

Drug: Hydromorphone

Weight-based Protocol

Experimental group

Description:

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

Treatment:

Drug: Morphine

Other: Weight-based Protocol

Drug: Hydromorphone