NL-OMON43411招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •1. Male and female SCD patients aged between 18 and 75 years (inclusive);
- •2. Moderate to severe stable SCD (HbSS HbSC or HBS-* thalassemia), with stable disease defined as no significant complications such as VOC, acute chest syndrome or any complication requiring in-patient hospitalization for at least one month prior to the baseline visit, and/or no acute transfusions for at least 2 months prior to the baseline visit.
- •3. Body mass index between 18-32 kg*m-2 (inclusive).
- •Haemophilia (hemophilia) patients
- •1. Haemophilia (hemophilia) patients aged between 18 and 75 years (inclusive);
- •2. Moderate to severe stable haemophilia (hemophilia) A or B, with factor activity of <1%.
- •3. Body mass index between 18-32 kg*m-2 (inclusive).
- •*-thalassemia patients
- •1. Male and female patients aged between 18 and 75 years (inclusive);
- •2. Diagnosis of *-thalassemia major (TM) as confirmed by hemoglobin electrophoresis and transfusion history.
- •3. No acute transfusions for at least 1 month (28 days) prior to the baseline or follow-up visits. (Patients may receive a transfusion on day 1 visit after testing is complete and again on day 28 visit after testing is complete)
- •4. Body mass index between 18-32 kg*m-2 (inclusive).
排除标准
- •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;
- •3. Condition of the skin that prohibits accurate mDLS or LSCI measurements, such as large tattoos, skin ulcers, scar tissue etc;
- •4. Unwillingness or inability to comply with the study procedures for any other reason.
研究者
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