NL-OMON43411
Recruiting
Not Applicable
Assessment of laser speckle contrast imaging (LSCI) and dynamic light scattering (mDLSTM) to detect differences in blood flow and coagulation between healthy volunteers and patients with coagulation disorders or hemoglobinopathies - Microvascular assessment in patients with coagulation disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Beta-thalassemia major
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All subjects must be able to participate and be willing to give written informed consent and to comply with the study restrictions. In addition, eligible subjects must meet the following inclusion criteria:;Healthy volunteers
- •1\. Healthy male or female subjects aged between 18 and 75 years (inclusive);
- •2\. Body mass index between 18\-32 kg\*m\-2 (inclusive).
- •Patients with target INR of 2\.0 \* 3\.0
- •1\. Male and female subjects aged between 18 and 75 years (inclusive), with stable (for at least a month) INR between 2\.0 \* 3\.0;
- •2\. Body mass index between 18\-32 kg\*m\-2 (inclusive).
- •Patients with target INR \*3\.0
- •1\. Male and female subjects aged between 18 and 75 years (inclusive), with a stable INR\*3\.0;
- •2\. Body mass index between 18\-32 kg\*m\-2 (inclusive).
- •Sickle cell disease patients
Exclusion Criteria
- •Eligible subjects must meet none of the following exclusion criteria at baseline:;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;
- •4\. The use of any medication or vitamin/mineral/herbal/dietary supplement within less than 5 half\-lives prior to study participation is prohibited, if the Investigator judges that it may interfere with the study objectives;
- •5\. Condition of the skin that prohibits accurate mDLS or LSCI measurements, such as large tattoos, skin ulcers, scar tissue etc;
- •6\. Unwillingness or inability to comply with the study procedures for any other reason.
- •Patient populations
- •1\. Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient;
- •2\. The use of any medication other than required for patients standard treatment, within less than 5 half\-lives prior to study participation is prohibited if the Investigator judges that it may interfere with the study objectives;
Outcomes
Primary Outcomes
Not specified
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