Assessment of blood flow velocity and oximetry using non-invasive retinal and cutaneous microcirculation imaging in sickle cell disease (SCD) patients and healthy volunteers.

Recruiting

• Conditions: sickle cell anaemia; Sickle cell disease; 10002086; 10005330

• Registration Number: NL-OMON40787
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

Inclusion criteria
Sickle cell disease patients
1. Male or female subjects, 18-65 years of age, inclusive;
2. Moderate to severe SCD with a history of at least 4 vaso-occlusive crises in total and at least 1 vaso-occlusive crisis in the last 12 months;;Healthy volunteers
1. Healthy subjects, as defined by the absence of evidence of any active or chronic disease following a medical and surgical history, a physical examination including vital signs.
2. Matched to sickle cell disease patients for gender, age (± 5 years), ethnicity, smoking behavior and body mass index (±3 kg/m2).

Exclusion Criteria

Sickle cell disease patients
1. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder, excluding SCD and conditions that are related to SCD.
2. Recent occurrence (<1 week preceding study day) of a vaso-occlusive crisis, defined as the need to be admitted to the hospital or to receive supportive treatment.
3. Recent transfusion therapy (<3 weeks preceding study day).
4. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
5. Concomitant disease or condition that could interfere with the conduct of the study or the study objectives.
(see protocol);Healthy volunteers
1. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
2. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
3. Concomitant disease or condition that could interfere with the conduct of the study or the study objectives, or that would, in the opinion of the Investigator, pose an unacceptable risk to the study participant.*

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified