Noninvasive Measurement of Blood Coagulation

NCT03217799 | Unknown

• 1 other identifier: 0227
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (3)

• Comparison of coagulability measurement with device vs. Prothrombin time

  In participants taking coumadin derivatives the results of the coagulation measurement obtained with the device will be compared to results of the Prothrombin time, in seconds, and INR

  One day

• Comparison of coagulability measurement with device vs. anti-Xa activity

  In participants taking coumadin derivatives the results of the coagulation measurement obtained with the device will be compared to results of the anti-Xa activity, measured as anti-Xa units/ml

  One day

• Comparison of coagulability measurement with device vs. PTT

  In participants taking heparin the results of the coagulation measurement obtained with the device will be compared to results of the PTT, seconds

  one day

Interventions

Measurement of coagulability of blood DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients attending the Coagulation clinic at Meir Hospital

You may qualify if:

• Subjects receiving anticoagulant therapy, including warfarin, DOACS, heparin, and antiplatelet drugs

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Hemostatic Disorders; Thrombosis; Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis

Central Study Contacts

Orli Avnery, MD

CONTACT

972-9-7471352; AVNERYHO@clalit.org.il

Martin Ellis, MD

CONTACT

972-9-741822; martinel@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Hematologist

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 14, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: July 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share