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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by St. Louis University
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
William Ferguson M.D., St. Louis University
ClinicalTrials.gov Identifier:
NCT01932554
First received: August 19, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
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
Drug: Abciximab
Drug: Placebo
Other: Intravenous hydration
Drug: Ibuprofen
Drug: Parenteral narcotic
Other: Incentive spirometry
Other: Supplemental oxygen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Abciximab (ReoPro) as a Therapeutic Intervention for Sickle Cell Vaso-Occlusive Pain Crisis

Resource links provided by NLM:


Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Duration of hospitalization [ Time Frame: Duration of hospital stay, expected average of 5 days ] [ Designated as safety issue: No ]
    Total duration from admission to the inpatient service until discharge order is written, measured in days.


Secondary Outcome Measures:
  • Total narcotic dose [ Time Frame: Duration of hospital stay, expected average of 5 days ] [ Designated as safety issue: No ]
    Total dose of parenteral narcotic administered during hospitalization, expressed as morphine equivalent per kg, will be calculated.

  • Bleeding complications [ Time Frame: From randomization until 10 days following initial discharge from hospital ] [ Designated as safety issue: Yes ]
    All major or minor bleeding manifestations during hospitalization or in the immediate post-discharge period, including site and severity, will be tracked

  • Complications (other than bleeding) attributed to study drug [ Time Frame: From randomization until 3 months following initial discharge from hospital ] [ Designated as safety issue: Yes ]
    All complications potentially related to abciximab therapy, other than bleeding, will be tracked.

  • Readmission rate [ Time Frame: From discharge date until 3 months following initial discharge from hospital ] [ Designated as safety issue: No ]
    All readmissions for any cause occurring within 3 months of discharge will be tracked.


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Patients will receive standard supportive care, including intravenous hydration, supplemental oxygen, incentive spirometry, ibuprofen, and parenteral narcotic pain medications (morphine, hydromorphone or fentanyl)

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.
Other Name: ReoPro
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
Other Name: Advil, Motrin
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 Names:
  • morphine
  • hydromorphone
  • Dilaudid
  • fentanyl
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.
Placebo Comparator: 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.

Patients will receive standard supportive care, including intravenous hydration, supplemental oxygen, incentive spirometry, ibuprofen, and parenteral narcotic pain medications (morphine, hydromorphone or fentanyl)

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
Other Name: Advil, Motrin
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 Names:
  • morphine
  • hydromorphone
  • Dilaudid
  • fentanyl
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932554

Contacts
Contact: William S Ferguson, MD 314-577-5638 fergusws@slu.edu
Contact: Donna Marin 314-577-5638 marind@slu.edu

Locations
United States, Missouri
Cardinal Glennon Children's Medical Center Recruiting
St. Louis, Missouri, United States, 63104
Contact: William S Ferguson, MD    314-577-5638    fergusws@slu.edu   
Contact: Donna Marin    314-577-5638    marind@slu.edu   
Principal Investigator: William S Ferguson, MD         
Sub-Investigator: Christopher Hugge, MD         
Sub-Investigator: Deepika Bhatla, MD         
Sub-Investigator: Shermini Saini, MD         
Sub-Investigator: John Puetz, MD         
Sub-Investigator: David W Griggs, PhD         
Sub-Investigator: Peter G Ruminski, MS         
Sub-Investigator: John T Chibnall, PhD         
Sponsors and Collaborators
St. Louis University
Janssen Services, LLC
Investigators
Principal Investigator: William S Ferguson, MD St. Louis University
  More Information

Publications:

Responsible Party: William Ferguson M.D., Professor of Pediatrics, St. Louis University
ClinicalTrials.gov Identifier: NCT01932554     History of Changes
Other Study ID Numbers: SLU 23331
Study First Received: August 19, 2013
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by St. Louis University:
Sickle Cell Pain Crisis
Abciximab
Integrins
Cell Adhesion Molecules

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Hydromorphone
Fentanyl
Morphine
Narcotics
Ibuprofen
Abciximab
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 18, 2014