Tissue Collection From People With Cystic Fibrosis
Completed
Conditions studied: Cystic Fibrosis
In brief
This study will examine the relationship between bacterial products in lung infections in cystic fibrosis and disease severity. It will examine plasma and lung tissue from cystic fibrosis patients. Patients with cystic fibrosis and having certain genetic characteristics, who are between 9 and 65 years of age and any cystic fibrosis patient undergoing lung transplantation at INOVA Fairfax Hospital in Fairfax, Virginia, may be eligible for this study. Patients who cannot undergo apheresis may be asked to provide up to an additional 100 cc (7 tablespoons) of blood for research to look at bacterial products. Lung specimens of participating transplant patients will be collected at INOVA Fairfax Hospital. Patients who participate in the apheresis portion of the study will be admitted to the NIH Clinical Center for 2 to 3 days. Apheresis is a procedure for collecting large quantities of specific blood components. For this study, plasma-the liquid part of the blood-will be collected. For the procedure, whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is separated into its components by centrifugation (spinning), the plasma and white cells are extracted and collected in a bag, and the red cells are returned to the body, either through the same needle or through another needle in the other arm. During the hospital stay, patients may also be asked to participate in other cystic fibrosis studies involving blood tests, an echocardiogram (ultrasound test of the heart), urine pregnancy test, and pulmonary function (breathing) tests.
Key facts
- Study ID
- NCT00015756
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 100
- Starts
- 2001-05-02
- Expected to finish
- 2008-04-21
- Last updated by the study team
- 2017-07-02
Who can join
Age: 9 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- There are no exclusion criteria for subjects in the transplant portion of the study.
- Patients with CF will be excluded from the apheresis portion of the study if they are less than 18 years, weigh less than 40kg, or demonstrate:
- Cardiovascular instability;
- Severe anemia (hematocrit less than 28 percent, hemoglobin less than10gm/ml);
- Thrombocytopenia (Platelets less than 50,000);
- Inadequate venous access in the upper extremities (No central venous catheters will be used);
- Severe coagulation disorder;
- Positive serology for hepatitis B, C, or HIV;
- Pregnancy;
- Pulmonary hypertension;
- Respiratory exacerbation requiring intravenous antibiotics;
- Any other condition which the physician or Apheresis Unit staff considers a contraindication to the procedure.
- Individuals who are unable to provide adequate consent/assent will be excluded from the study.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- Medical College of Wisconsin 8701 Watertown Plank Road Milwaukee, WI 53226 — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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