Abciximab (ReoPro) as a Therapeutic Intervention for Sickle Cell Vaso-Occlusive Pain Crisis

Summary

The purpose of this study is to determine whether giving abciximab (ReoPro) to children with sickle cell disease who are hospitalized for acute pain crisis will improve their pain and shorten the time spent in the hospital, when compared with standard supportive care.

Conditions

• Sickle Cell Disease
• Hb-SS Disease With Vasoocclusive Pain
• Hemoglobin SS Disease With Vasoocclusive Crisis
• Other Sickle Cell Disease With Vaso-Occlusive Pain
• Hemoglobin SS Disease With Crisis

Interventions

DRUG

Abciximab

Abciximab will be administered as initial bolus of dose of 0.25 mg/kg, delivered via syringe pump over 15 minutes, followed by a continuous infusion of 0.125 microgram/kg/min (max of 10 micrograms/min) infused over the next 12 hours. Infusion to start within 16 hours of admission. All patients will receive standard supportive care measures.

DRUG

Placebo

Inactive placebo will be administered as initial bolus followed by a continuous infusion over the next 12 hours, in syringes and volumes identical with the drug administered in the experimental arm. Infusion to begin within 16 hours of admission. All patients will also receive standard supportive care measures.

OTHER

Intravenous hydration

intravenous hydration to provide total fluid intake of 1.25-1.5 times maintenance fluid requirements

DRUG

Ibuprofen

Scheduled ibuprofen,\~10 mg/kg every 6-8 hours

DRUG

Parenteral narcotic

Parenteral morphine administered by bolus or patient-controlled analgesia to maintain pain control. Hydromorphone or fentanyl will be used in patients who do not tolerate morphine.

OTHER

Incentive spirometry

Patients will perform incentive spirometry every 2 hours while awake

OTHER

Supplemental oxygen

Supplemental oxygen by nasal cannula or mask will be provided if needed to maintain oxygen saturation of 92% or greater.

Sponsors & Collaborators

• Janssen Services, LLC

  collaborator INDUSTRY

• St. Louis University

  lead OTHER

Principal Investigators

• William S Ferguson, MD · St. Louis University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• United States

Study Locations