Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041574
Status:
TERMINATED
Last Update Posted:
2016-09-09
First Post:
2002-07-10
Brief Title:
Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed for lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory home-care patients To understand patient needs patients with a variety of underlying diseases will be included Safety of chronic therapy will be monitored by serial measurements of methemoglobin platelet function assay and reported adverse events
Detailed Description:
This study will help develop a comprehensive home care program using INOmax delivery systems This study will enroll a limited number of patients 5-7 from several disease categories in order to develop the experience with testing acute and chronic responsiveness to INO therapy The following groups will be tested
1 Primary pulmonary hypertension PPH
2 Severe pulmonary hypertension due to congenital anatomic heart disease
3 Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease
4 Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults
5 Pulmonary hypertension or severe impairment of gas exchange in hematologic and transplant disorders - young children and adults with sickle cell disease chronic lung disease after bone marrow transplant cardiac transplant or lung transplant
1 Primary pulmonary hypertension PPH
2 Severe pulmonary hypertension due to congenital anatomic heart disease
3 Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease
4 Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults
5 Pulmonary hypertension or severe impairment of gas exchange in hematologic and transplant disorders - young children and adults with sickle cell disease chronic lung disease after bone marrow transplant cardiac transplant or lung transplant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None