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NCT00023296 · ClinicalTrials.gov registry record · Phase 1
Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension
A Phase 1 study of Pulmonary Hypertension and Sickle Cell Anemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 2
- Study locations
NCT00023296 is a Phase 1 study of Pulmonary Hypertension and Sickle Cell Anemia that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 59 participants, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00023296, a Phase 1 study of Pulmonary Hypertension and Sickle Cell Anemia, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell anemia. Patients with sickle cell disease 18 years of age or older may be eligible to participate in one or more parts of this three-stage study, as follows: Stage 1 Patients undergo the following tests to determine the cause of their pulmonary hypertension: blood tests; echocardiogram (heart ultrasound); asthma test; oxygen breathing study with measurement of arterial blood oxygen levels; chest X-ray; lung scans; MRI of the heart; 6-minute walk test; night-time oxygen measurement while sleeping; and exercise studies. Stage 2 Patients have a detailed MRI evaluation of the heart and are admitted to the NIH Clinical Center intensive care unit (ICU) for the following test: A plastic tube is placed in a vein in the patient's arm and another tube is placed in a deeper neck or leg vein. A third tube is inserted through the vein into the heart and the lung artery to measure blood pressures in the heart and lungs directly. Following baseline measurements, three medications (inhaled oxygen, infused prostaglandin, and inhaled NO) are delivered for 2 hours each, separated by a 30-minute washout period. A small blood sample is drawn during the NO administration. Patients who cannot be treated with nitric oxide or for whom the treatment does not work may receive monthly exchange transfusions for 3 months. For this procedure, 3 to 5 five units of the patient's blood is removed and replaced with 3 to 5 units that do not have sickle hemoglobin. Some patients who do not respond to NO or exchange transfusions may receive an alternative therapy, such as oxygen, prostacyclin, L-arginine, bosentan or sidenafil. Stage 3 Patients remain in the ICU with catheters in place for another 24 hours. During this time they breathe NO. Lung pressures are measured every 4 hours and blood is drawn every 8 hours. They
Conditions Studied
Interventions
- DRUG Nitric Oxide
- DEVICE INO Pulse - NO Delivery System
Study Locations (2)
Maryland
- Suburban Hospital - Bethesda
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2001-07-27 |
| Est. Completion | 2015-11-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00023296
The ClinicalTrials.gov registry entry for NCT00023296 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (90% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Nitric Oxide is the first listed.
NCT00023296 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00023296 about?
NCT00023296 is a clinical study titled "Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension". This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell anemia. Patients with sickle cell disease 18 years of age or older may be eligible to participate in one or more parts o...
What is the current status of trial NCT00023296?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2001-07-27. Estimated completion is 2015-11-09.
What conditions does trial NCT00023296 study?
This clinical trial studies the following conditions: Pulmonary Hypertension, Sickle Cell Anemia.
What interventions are being tested in trial NCT00023296?
The interventions under investigation include: Nitric Oxide (DRUG), INO Pulse - NO Delivery System (DEVICE).
Who is sponsoring clinical trial NCT00023296?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00023296 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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