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CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients (CALIPSO)

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ClinicalTrials.gov Identifier: NCT00999713
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : November 23, 2015
Information provided by (Responsible Party):
Neal J. Thomas, Penn State University

Brief Summary:

Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these children represent a relatively small and unique patient population, they account for the largest proportion of deaths of all pediatric diseases. The long-term goal of this project is to improve outcomes among these patients. Recently, the intratracheal administration of calfactant has resulted in decreased mortality among children with ALI including promising results among children with cancer and following HSCT. Consequently, the primary specific aim of this study is to assess the effect of calfactant on intensive care (PICU) survival among pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung injury in the overall pediatric population by improving oxygenation and decreasing mortality. These findings, in conjunction with recent subgroup analysis in which calfactant therapy appeared to improve outcomes in immunocompromised children provide the rationale for assessing calfactant therapy in this patient population.

Funding Source - FDA OOPD

Condition or disease Intervention/treatment Phase
Acute Lung Injury Drug: Calfactant Other: Air placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients
Study Start Date : June 2010
Primary Completion Date : September 2015
Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Calfactant
Endotracheal calfactant administration
Drug: Calfactant
Endotracheal calfactant, up to 3 doses if subject qualifies
Placebo Comparator: Placebo (air)
Endotracheal air administration
Other: Air placebo
Endotracheal air administration

Primary Outcome Measures :
  1. All-cause mortality at the time of PICU discharge [ Time Frame: PICU discharge ]

Secondary Outcome Measures :
  1. Total duration of mechanical ventilation required during PICU admission. [ Time Frame: PICU discharge ]
  2. Total duration of PICU and hospital stay required. [ Time Frame: Hospital discharge ]
  3. Improvement in oxygenation, as measured by oxygenation index, in the initial 48 hours after treatment [ Time Frame: 48 hours after enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must meet criteria for acute lung injury

    • Intubated, mechanically ventilated, with respiratory failure secondary to diffuse, bilateral parenchymal lung disease (as judged by chest x-ray).
    • Oxygenation index (OI) > 13, but < 37, for two consecutive blood gases which should be separated by at least one hour within 48 hours of the initiation of mechanical ventilation.
    • Arterial catheter placement
    • Parental informed consent
  2. Patients must have a diagnosis of leukemia/lymphoma undergoing active treatment or following HSCT for any indication. Leukemia/lymphoma will be defined according to the National Cancer Institute Surveillance Epidemiology and End Results Collaborative Staging Manual including those conditions defined as borderline such as myelodysplastic syndromes. All forms of HSCT will be eligible, allogeneic as well as autologous.

Exclusion Criteria:

  1. Clinical diagnosis of congestive heart failure and/or pulmonary capillary wedge pressure >15 mmHg, or uncorrected congenital heart disease.
  2. Glasgow Coma Score < 8 (prior to respiratory failure).
  3. Pre-existing limitations on care options, (Do Not Attempt Resuscitation Orders, etc).
  4. Patients with impending death from another disease.
  5. Patients moribund or with other organ failure at possible randomization:

    • hypotension unresponsive to treatment (mean BP < 60 or < 5th % for age),
    • persistent cardiac tachyarrhythmia >150/minute, or persistent bradyarrythmia < 50/minute, or age appropriate criteria for younger children,
    • metabolic acidosis > - 10 mEq/L for more than 2 hours,
    • persistent arterial oxygen desaturation, PaO2 < 50 or SaO2saturation < 80%,
    • hyperkalemia, serum K+ > 6.5 plus widening of QRS complex on EKG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999713

United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francicso, California, United States
United States, Indiana
Riley Children's Hospital
Indianapolis, Indiana, United States
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States
United States, New York
Weill Cornell Medical Center
New York, New York, United States
Maria Fareri Children's Hospital
Valhalla, New York, United States
United States, Ohio
Rainbow Babies Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17078
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
United States, Texas
Texas Children's Hospital
Houston, Texas, United States
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Canada, Quebec
Hospital Sainte Justine
Montreal, Quebec, Canada
Sponsors and Collaborators
Penn State University
Principal Investigator: Neal J Thomas, MD, MSc Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Principal Investigator: Robert F Tamburro, MD, MSc Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Responsible Party: Neal J. Thomas, Neal J. Thomas, MD, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Penn State University
ClinicalTrials.gov Identifier: NCT00999713     History of Changes
Other Study ID Numbers: 1R01FD003410-01 ( U.S. FDA Grant/Contract )
R01FD003410-01A1 ( U.S. FDA Grant/Contract )
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: November 2015

Keywords provided by Neal J. Thomas, Penn State University:
Acute Lung Injury

Additional relevant MeSH terms:
Wounds and Injuries
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders
Pulmonary Surfactants
Respiratory System Agents