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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01932554

Run by

St. Louis University

People needed

0

Starts

2013-11-01

Expected to finish

2015-03-01

Last updated by the study team

2015-03-26

Who can join

Age: 5 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of sickle cell disease (Hb SS, HbSC, HbS-β0-thalassemia)
• Age 5.00 to 24.99 years
• Pain consistent with vaso-occlusive crisis that meets the criteria for hospitalization and parenteral narcotics: moderate-severe pain unresponsive to oral medications (NSAIDS + narcotics) that has no alternative etiology (e.g., trauma)
• Platelet count >100,000
• INR <1.2, PTT < 40 seconds
• Negative urine pregnancy test for females of child-bearing potential, including any female ≥10 years of age
• Informed consent by patient (≥18 years of age) or parent (if patient <18 years of age); assent from patients 12-18 years of age
• Ability to start drug/placebo infusion within 16 hours of admission

You may not qualify if…

• History of stroke (either ischemic or hemorrhagic)
• Currently receiving anticoagulation medication (heparin within 1 week, Coumadin within 3 weeks) or medication with irreversible anti-platelet effect (e.g., aspirin, ticlopidine) within 14 days
• Red cell transfusion within 60 days
• Major surgery within 30 days
• Treatment with hydroxyurea within 30 days (due to evidence that hydroxyurea can reverse platelet activation in patients with SCD)
• Tmax ≥ 102.0o F without concomitant signs of infection, or ≥ 100.4o F with any finding suggestive of bacterial infection, including acute chest syndrome (fever, respiratory symptoms, and new infiltrate on chest X-ray)
• Active internal bleeding
• Known allergy to abciximab or murine proteins
• Recent (within 6 weeks) gastrointestinal or genitourinary bleeding of clinical significance
• Bleeding diathesis
• History of vasculitis
• Intracranial neoplasm, arteriovenous malformation or aneurysm
• Severe uncontrolled hypertension
• Patients who previously participated in the study must be excluded due to the increased risk of severe thrombocytopenia.

Where it is running

• Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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