Primary objective- Short- and mid-term repeatability of mDLS and LSCI measures;- Comparison of blood flow obtained by LSCI and blood flow obtained by mDLS;- Comparison of coagulation status obtained by mDLS and coagulation status assessed by…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Blood and lymphatic system disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
mDLS measures
1. Directly measured
a. Pulse rate
b. Deep respiratory rate
c. Blood flow
d. Blood flow velocity
e. Traube-Hering waves
2. Indirectly measured
a. Global coagulation status
b. Rheological characteristics of blood
c. Endothelial function
d. Relative cardiac output
e. Vascular health
LSCI measures
1. Basal blood flow
2. Blood flow upon occlusion-reperfusion
Laboratory measures
1. Iron, TIBC and ferritin panel
2. Bilirubin (total and fractionated)
3. Lactate dehydrogenase
4. Prothrombin time (INR)/Activated Partial Thromboplastin Time
5. Fibrinogen
6. Complete blood count with differential
7. Erythrocyte Sedimentation rate (ESR)
8. GDF 11/15
9. Endothelin 1
10. Red cell membrane PS/PE (Phosphatidylserine/phosphatidylethanolamine)
11. Haptoglobin
12. Hepcidin
Collected data or samples may also be used to derive other measures, when
considered to be in line with the objectives of the research protocol.
Secondary outcome
Not applicable
Background summary
Elfi-Tech has developed an innovative, non-invasive optical technology based on
DLS (Dynamic Light Scattering). This novel technique continuously and
non-invasively measures skin blood flow as well as rheologic characteristics of
blood, which is claimed to be translated into quantitative measures for
coagulation status and vascular ageing . The mDLS sensor is easily deployed,
simple to operate and robust. Its raw signals are, via proprietary algorithms,
translated into novel indices of red cell flow and vascular health, including:
endothelial function and global coagulation status of the blood In addition, by
analyzing the high-resolution blood pulse wave, the sensor can continuously and
non-invasively measure a set of physiological parameters such as respiratory
rate, systolic blood pressure trends, cardiac contractility, cardiac valve
dysfunction and Traube-Hering-Mayer oscillations.
Little is known about the performance and the validation of the device for
clinical (pharmacology) research. This is important as read-outs from devices
used in clinical research, should be reproducible, accurate, show little
variability, and sensitive to small changes. It is therefore proposed to
perform a project that will assist in qualifying the parameters of this device.
This study will be an open observational study with the objective to explore
the performance of the mDLS sensor in clinical research. The variability of the
methodology over time will be assessed in healthy subjects and patients with a
known altered coagulation status and possibly microvascular flow. This will to
explore whether mDLS-derived coagulation measures discriminate between patients
with coagulation disorders, hemoglobinopathies and healthy volunteers. Blood
flow as assessed by mDLS and LSCI will be benchmarked against standard
laboratory measurements of red cells and coagulation.
Study objective
Primary objective
- Short- and mid-term repeatability of mDLS and LSCI measures;
- Comparison of blood flow obtained by LSCI and blood flow obtained by mDLS;
- Comparison of coagulation status obtained by mDLS and coagulation status
assessed by laboratory measures (e.g. PT/INR, APTT, fibrinogen).
Secondary objectives
- To explore the difference in coagulation status, as measured by mDLS, between
INR 2.0-3.0 patients, INR * 3.0 patients, Sickle Cell Disease (SCD) patients,
Hemophilia A/B patients, Beta-thalassemia major (TM) patients and healthy
volunteers;
- To evaluate biomarkers that may be informative in demonstrating the
difference in vascular function, red cell health and coagulation status between
healthy volunteers and patients with a range of disease pathophysiologies
impacting coagulation and red cell function;
- To evaluate the effect of occlusion-reperfusion on cutaneous blood flow as
assessed by LSCI and mDLS.
Study design
Open observational, single center study
Study burden and risks
This is an observational study without pharmacological intervention. The
primary assessments that the study participants will undergo are measurement of
vascular function by mDLS and LSCI, with temporary occlusion (of the brachial
artery or index finger). These are non-invasive methods, commonly applied in
human studies on vascular functionality, with a negligible risk for the study
participants. In addition, blood will be collected to assess coagulation and
red cell status, which may cause discomfort for the volunteer. Study
participants will be studied in a state-of the-art clinical unit and medically
supervised by qualified medical staff.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
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
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).
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;
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.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL55947.058.16 |