Thromboelastography (TEG) Reference Range Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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As part of a system wide reagent verification plan Haemoscope Corporation will be running a study to verify the reference intervals of many of the reagents. Reference intervals will be constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls for a reference interval to be constructed from at least 120 donors. Some reagents currently have ranges in place based on fewer donors than that stated in the guideline. This procedure will provide additional testing results to meet the requirements outlined in the CLSI guideline. Reagents that currently have no reference intervals will be tested and will include a minimum of 146 donors.

Detailed Description

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Conditions

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Coagulation

Keywords

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TEG Thromboelastography Coagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or Female over the age of 18 years.

Exclusion Criteria

* Genetic bleeding disorders
* Currently Pregnant
* Oral Contraceptives
* On anti-coagulants or anti-platelet therapy
* Took ASA (Acetylsalicylic Acid)within 1 week prior
* Recent surgery (within 4 weeks)
* Recent injury leading to substantial bruising (within 2 weeks)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William A Heaton, M.D.

Role: PRINCIPAL_INVESTIGATOR

NSLIJ Health System

Locations

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North Shore-Long Island Jewish Health System

Manhasset, New York, United States

Site Status

Countries

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United States

Other Identifiers

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TP-CLN-100048C

Identifier Type: -

Identifier Source: org_study_id