Status:
WITHDRAWN
Near Infrared Spectroscopy in Sickle Cell Pediatric Patients
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
6-21 years
Brief Summary
Endothelial dysfunction contributes to vaso-occlusion and acute pain in sickle cell disease. Near infrared spectroscopy (NIRS) technology can measure tissue oxygenation and endothelial function. The m...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Subjects with Sickle Cell Disease in Pain Crisis:
- Age 6 to 21 years old.
- Diagnosis of sickle cell anemia: a. Diagnosis of sickle cell disease (electrophoresis or HPLC documentation of hemoglobin SS, SC, S-beta-thalassemia or other hemoglobinopathies causing sickle cell disease is required).
- Acute onset pain crisis in a distribution typical for that subject, onset within the last 7 days and for which hospitalization and parenteral narcotic pain treatment are required.
- Ability to provide informed written consent.
- Exclusion Criteria for Subjects with Sickle Cell Disease in Pain Crisis:
- Pregnancy.
- History of non-trivial injury, burns, surgery or skin ulcers on the arms.
- Fever or suspected sepsis at time of pain crisis
- Administration of any of the following drugs within the last 14 days:
- Phosphodiesterase-5 inhibitors (sildenafil, vardenafil, tadalafil)
- Endothelin-1 receptor blockers (bosentan, sitaxentan, ambrisentan, tezosentan)
- Nitric oxide donors (nitroglycerin, nitroprusside, nitrates)
- Ingestion of caffeine within the 12 hours before the start of the study appointment, or tobacco use within the 30 days before the study appointment.
- Diagnosis with any of the following chronic diseases or conditions:
- History of high blood pressure
- History of high cholesterol
- History of diabetes
- History of chronic kidney disease (serum creatinine must not be greater than 2 mg/dL)
- History of coronary artery disease or peripheral vascular disease
- Received a blood transfusion within 7 days of the study procedure.
- Inclusion Criteria for Subjects with Sickle Cell Disease in Steady State:
- Age 6-21 years
- Diagnosis of sickle cell disease (electrophoresis or HPLC documentation of hemoglobin SS, SC, S-beta-thalassemia or other hemoglobinopathies causing sickle cell disease is required).
- Ability to provide informed written consent.
- Exclusion Criteria for Subjects with Sickle Cell Disease in Steady State:
- Pregnancy.
- History of non-trivial trauma, burns, surgery or skin ulcers on the arms.
- Fever or suspected sepsis at time of pain crisis
- Experience of an acute pain crisis requiring intravenous (IV) narcotics and hospital admission within the last 14 days.
- Ingestion of caffeine within the 12 hours before the start of the study appointment, or tobacco use within the 30 days before the study appointment.
- Administration of any of the following drugs within the last 14 days:
- Phosphodiesterase-5 inhibitors (sildenafil, vardenafil, tadalafil)
- Endothelin-1 receptor blockers (bosentan, sitaxentan, ambrisentan, tezosentan)
- Nitric oxide donors (nitroglycerin, nitroprusside, nitrates)
- Diagnosis of any of the following chronic diseases or conditions:
- History of high blood pressure
- History of high cholesterol
- History of diabetes
- History of chronic kidney disease (serum creatinine must not be greater than 2 mg/dL)
- History of coronary artery disease or peripheral vascular disease
- Received a blood transfusion within 7 days of the study procedure.
Exclusion
Key Trial Info
Start Date :
June 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 3 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04031521
Start Date
June 26 2019
End Date
September 3 2023
Last Update
September 14 2023
Active Locations (1)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010