This study is NOT currently recruiting participants.
Number
17-H-0056
Sponsoring Institute
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: 80 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Pain; Cell Free DNA; Inflammatory Markers; Microparticles; NETosis; Natural History
Recruitment Keyword(s)
None
Condition(s)
Sickle Cell Disease
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Heart, Lung, and Blood Institute
Sickle Cell Disease (SCD) is a blood disorder that occurs mainly in people of African descent. Researchers want to learn more about the painful attacks and complications associated with SCD. They want to look for a relationship between SCD and specific changes in the blood. They want to study the role of genetics, inflammation, and blood clotting factors in SCD. They will do this with blood samples collected during an acute painful attack and in between attacks.
Objective:
To learn more about the painful attacks and complications associated with SCD.
Eligibility:
People ages 18-80 with SCD or who are healthy Africans or African Americans without SCD
Design:
-Participants will be screened with medical history and physical exam.
-Healthy participants will have one visit.
-Participants with SCD will have their first visit when they are not having a pain attack. They will have their next visit during a pain attack. About 3-4 months after this attack, they will have a final visit.
-Visits will include a physical exam, and blood and urine tests.
-Participants may have their blood samples used for genetic testing for research.
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SUBJECT INCLUSION CRITERIA (SCD): 1. Sickle cell disease (all genotypes) with a diagnosis of acute sickle cell pain not related to other cause (if the patient also presents with any other sickle related complication alongside acute sickle pain, including not limited to acute chest syndrome, renal dysfunction, liver dysfunction, stroke and priapism can also be included in the study) 2. Between 18 and 80 years of age 3. Ability to provide informed written consent SUBJECT EXCLUSION CRITERIA (SCD): 1. <18 years of age 2. Pregnancy 3. Chronic inflammatory condition (e.g. SLE, Rheumatoid arthritis or any other infectious process leading to chronic inflammation) 4. Failed stem cell transplantation for SCD 5. On active treatment with cytotoxic or immunosuppressive therapy INCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS: 1. Between 18 and 80 years of age 2. African, of African descent 3. Ability to provide informed written consent EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS: 1. Pregnancy 2. Diagnosis of with any of the following chronic disease or conditions: a. Sickle cell disease or sickle cell trait b. Uncontrolled high blood pressure (systolic blood pressure must not be greater than 160 mmHg or diastolic pressure greater than 90 mmHg c. Uncontrolled diabetes (must not have both a documented history of diabetes and random blood glucose of greater than 200 mg/dL) d. History of coronary artery disease e. History of congestive heart failure f. Chronic kidney disease (serum creatinine must not be greater than 2mg/dL)
1. Sickle cell disease (all genotypes) with a diagnosis of acute sickle cell pain not related to other cause (if the patient also presents with any other sickle related complication alongside acute sickle pain, including not limited to acute chest syndrome, renal dysfunction, liver dysfunction, stroke and priapism can also be included in the study)
2. Between 18 and 80 years of age
3. Ability to provide informed written consent
SUBJECT EXCLUSION CRITERIA (SCD):
1. <18 years of age
2. Pregnancy
3. Chronic inflammatory condition (e.g. SLE, Rheumatoid arthritis or any other infectious process leading to chronic inflammation)
4. Failed stem cell transplantation for SCD
5. On active treatment with cytotoxic or immunosuppressive therapy
INCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS:
1. Between 18 and 80 years of age
2. African, of African descent
EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS:
1. Pregnancy
2. Diagnosis of with any of the following chronic disease or conditions:
a. Sickle cell disease or sickle cell trait
b. Uncontrolled high blood pressure (systolic blood pressure must not be greater than 160 mmHg or diastolic pressure greater than 90 mmHg
c. Uncontrolled diabetes (must not have both a documented history of diabetes and random blood glucose of greater than 200 mg/dL)
d. History of coronary artery disease
e. History of congestive heart failure
f. Chronic kidney disease (serum creatinine must not be greater than 2mg/dL)
Principal Investigator
Referral Contact
For more information: