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Near Infrared Spectroscopy in Sickle Cell Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04031521
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Suvankar Majumdar, Children's National Research Institute

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 main objective of this study is to study the natural history of tissue muscle oxygenation using NIRS in pediatric sickle cell subjects experiencing acute pain and pediatric sickle cell patients in steady-state.

Condition or disease Intervention/treatment
Sickle Cell Disease Diagnostic Test: Near infrared spectroscopy

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Near-infrared Spectroscopy in Sickle Cell Pediatric Patients During Pain Crisis and After Recovery
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sickle cell pain crisis Diagnostic Test: Near infrared spectroscopy
NIRS is an emerging technology for measuring tissue oxygenation and endothelial function. NIRS light can penetrate through biological tissues, including skin, bone, and muscle. Similar to other optical methods, light is applied to the region of interest and undergoes scattering and absorption before being detected by a photosensor. This technique is commonly used to assess oxygen availability and consumption in living tissues. Using different wavelengths, NIRS can differentiate between oxygenated and deoxygenated hemoglobin in blood and can measure changes in total hemoglobin concentration, using the sum of oxygenated and deoxygenated hemoglobin.

Sickle cell steady-state Diagnostic Test: Near infrared spectroscopy
NIRS is an emerging technology for measuring tissue oxygenation and endothelial function. NIRS light can penetrate through biological tissues, including skin, bone, and muscle. Similar to other optical methods, light is applied to the region of interest and undergoes scattering and absorption before being detected by a photosensor. This technique is commonly used to assess oxygen availability and consumption in living tissues. Using different wavelengths, NIRS can differentiate between oxygenated and deoxygenated hemoglobin in blood and can measure changes in total hemoglobin concentration, using the sum of oxygenated and deoxygenated hemoglobin.




Primary Outcome Measures :
  1. Tissue oxygenation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Nitric oxide [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects 6 to 21 years of age of all sickle cell genotypes
Criteria

Inclusion Criteria for Subjects with Sickle Cell Disease in Pain Crisis:

  1. Age 6 to 21 years old.
  2. 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).
  3. 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.
  4. Ability to provide informed written consent.

Exclusion Criteria for Subjects with Sickle Cell Disease in Pain Crisis:

  1. Pregnancy.
  2. History of non-trivial injury, burns, surgery or skin ulcers on the arms.
  3. Fever or suspected sepsis at time of pain crisis
  4. 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)
  5. 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.
  6. 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
  7. Received a blood transfusion within 7 days of the study procedure.

Inclusion Criteria for Subjects with Sickle Cell Disease in Steady State:

  1. Age 6-21 years
  2. 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).
  3. Ability to provide informed written consent.

Exclusion Criteria for Subjects with Sickle Cell Disease in Steady State:

  1. Pregnancy.
  2. History of non-trivial trauma, burns, surgery or skin ulcers on the arms.
  3. Fever or suspected sepsis at time of pain crisis
  4. Experience of an acute pain crisis requiring intravenous (IV) narcotics and hospital admission within the last 14 days.
  5. 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.
  6. 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)
  7. 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
  8. Received a blood transfusion within 7 days of the study procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031521


Contacts
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Contact: Suvankar Majumdar, MD 2024763800 smajumdar@childrensnational.org
Contact: Elaine Passley, CCRP 2024765532 epassleycu@childrensnational.org

Locations
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United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's National Research Institute
National Institute of Allergy and Infectious Diseases (NIAID)

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Responsible Party: Suvankar Majumdar, Chief of Hematology, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT04031521    
Other Study ID Numbers: Pro00012424
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn