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Noninvasive Measurement of Blood Coagulation

NCT03217799 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2017-07-19

No results posted yet for this study

Summary

The investigators have developed an optical system that measures the coagulation status of patients in vivo in a non-invasive manner. The system is based on a small optical sensor that emits coherent light into the skin and collects the reflected light from the red blood cells in the blood vessels in the skin under the sensor. The sensor is placed on the fingertip, and during a brief period of occlusion of blood flow by a small pneumatic cuff, red cell movement becomes Brownian in nature and is thereby affected by the viscosity of the blood. In patients who have a bleeding tendency, red blood cell movement will be faster, while in patients with a hypercoagulable state the red cell movement will be slower. Treatment with anticoagulant medications is expected to affect the movement of the red blood cells and these changes can be detected by the sensor. The investigators plan to test the device in normal subjects and in subjects taking Coumadin, direct oral anticoagulants, antiplatelet drugs and heparin-based medications. The investigators will determine whether anticoagulants affect the noninvasive measurement and compare the results with standard laboratory tests of coagulation.

Conditions

  • Anticoagulants; Increased
  • Anticoagulant Overdosage
  • Coagulation Disorder
  • Blood Clot
  • Blood Coagulation Disorder

Interventions

DEVICE

Measurement of coagulability of blood

A small pneumatic cuff is attached to the root of the index finger. The sensor cuff is attached several centimeters distal to the pneumatic cuff. Measurement is taken for a 60-second control period, and then the pneumatic cuff is inflated to above-systolic blood pressure (200 mm Hg) for 180 seconds, and measurement is taken during this period of time. The cuff is then deflated, and another 60-second measurement is taken. Data is collected by the measuring device for later analysis.

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-12-31
Completion
2019-07-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217799 on ClinicalTrials.gov