Blood Flow and Pain Crises in People With Sickle Cell Disease

NCT01568710 | Completed

• 2 other identifiers: 12010112-H-0101
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Many people with sickle cell disease have repeated episodes of severe pain that lasts for days, requiring hospital care. These episodes, called pain crises, may be caused by changes in blood flow. Researchers want to study blood flow in people with sickle cell disease who are having a pain crisis and compare it with their blood flow after the pain crisis has resolved. They also want to compare these measurements against blood flow in healthy people who do not have sickle cell disease. Objectives: \- To study whether changes in blood flow cause pain crises in people with sickle cell disease. Eligibility:

• Individuals at least 18 years of age who have sickle cell disease and are being treated for a pain crisis.
• Individuals at least 18 years of age who have sickle cell disease and are not experiencing a pain crisis.
• Healthy volunteers matched by age and gender with the participants who have sickle cell disease. Design:
• Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
• Participants having a sickle cell pain crisis will have two visits, one during the crisis and one about 4 weeks after the crisis has resolved.
• Participants not having a sickle cell pain crisis will have one or two study visits. Blood samples will be collected during at least one of these visits.
• Healthy volunteers will have one or two study visits. Blood samples will be collected during at least one of these visits.
• During each visit for all participants, cameras and blood flow monitoring equipment will be used to measure blood flow in the forearm. sickle cell disease.

Conditions

Sickle Cell Disease

Keywords

Blood Flow; Endothelium; Nitric Oxide; Oximetry; Laser Doppler; Sickle Cell Disease

Outcome Measures

Secondary Outcomes (3)

• Skin Blood Flood

  1 month

• Skin Temperature

  1 month

• Tissue oxygenation

  1 month

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Diagnosis of sickle cell anemia:
• 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.

You may not qualify if:

• Pregnancy.
• History of non-trivial injury, burns, surgery or skin ulcers on the arms.
• Carrier of drug resistant bacteria that normally requires isolation while visiting a hospital.
• 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:
• Uncontrolled high blood pressure (systolic blood pressure must not be greater than 160 mmHg or diastolic blood pressure greater than 90 mmHg)
• Uncontrolled high cholesterol (total cholesterol must not be greater than 240 mg/dL)
• Uncontrolled diabetes (must not have both a documented history of diabetes and random blood glucose of greater than 200 mg/dL)
• Chronic kidney disease (serum creatinine must not be greater than 2 mg/dL)
• Coronary artery disease
• Peripheral vascular disease

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.

  PMID: 1710777 BACKGROUND

• Nagel RL. Sickle cell anemia is a multigene disease: sickle painful crises, a case in point. Am J Hematol. 1993 Jan;42(1):96-101. doi: 10.1002/ajh.2830420119. No abstract available.

  PMID: 8416304 BACKGROUND

• Hebbel RP, Vercellotti GM. The endothelial biology of sickle cell disease. J Lab Clin Med. 1997 Mar;129(3):288-93. doi: 10.1016/s0022-2143(97)90176-1. No abstract available.

  PMID: 9042813 BACKGROUND

• Rowley CA, Ikeda AK, Seidel M, Anaebere TC, Antalek MD, Seamon C, Conrey AK, Mendelsohn L, Nichols J, Gorbach AM, Kato GJ, Ackerman H. Microvascular oxygen consumption during sickle cell pain crisis. Blood. 2014 May 15;123(20):3101-4. doi: 10.1182/blood-2013-11-533406. Epub 2014 Mar 24.

  PMID: 24665133 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hans C Ackerman, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 2, 2012
• Study Start: March 21, 2012
• Study Completion: October 5, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10-05

Locations

US (1)