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

• Status: Withdrawn
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Collaborator: Janssen Services, LLC
• Treatments: Abciximab; Antibodies, Monoclonal; Fentanyl; Hydromorphone; Ibuprofen; Immunoglobulin Fab Fragments; Morphine; Narcotics

Criteria

Inclusion Criteria:

1. Diagnosis of sickle cell disease (Hb SS, HbSC, HbS-β0-thalassemia)

2. Age 5.00 to 24.99 years

3. 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)

4. Platelet count >100,000

5. INR <1.2, PTT < 40 seconds

6. Negative urine pregnancy test for females of child-bearing potential, including any female ≥10 years of age

7. Informed consent by patient (≥18 years of age) or parent (if patient <18 years of age); assent from patients 12-18 years of age

8. Ability to start drug/placebo infusion within 16 hours of admission

Exclusion Criteria:

1. History of stroke (either ischemic or hemorrhagic)

2. 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

3. Red cell transfusion within 60 days

4. Major surgery within 30 days

5. Treatment with hydroxyurea within 30 days (due to evidence that hydroxyurea can reverse platelet activation in patients with SCD)

6. 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)

7. Active internal bleeding

8. Known allergy to abciximab or murine proteins

9. Recent (within 6 weeks) gastrointestinal or genitourinary bleeding of clinical significance

10. Bleeding diathesis

11. History of vasculitis

12. Intracranial neoplasm, arteriovenous malformation or aneurysm

13. Severe uncontrolled hypertension

14. Patients who previously participated in the study must be excluded due to the increased risk of severe thrombocytopenia.