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A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients

Phase 2/Phase 3
18 Months
21 Years
Open (Enrolling)
Acute Lung Injury

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Trial Information

A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

All-cause mortality at the time of PICU discharge

Outcome Time Frame:

PICU discharge

Safety Issue:


Principal Investigator

Neal J Thomas, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

  • Acute Lung Injury
  • Acute Lung Injury
  • Cancer
  • Pediatrics
  • Acute Lung Injury
  • Respiratory Distress Syndrome, Adult
  • Lung Injury



Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Children's Hospital of WisconsinMilwaukee, Wisconsin  53201
Texas Children's HospitalHouston, Texas  
The Nebraska Medical CenterOmaha, Nebraska  68198
Penn State College of Medicine, Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033