Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss
NCT ID: NCT03990376
Last Updated: 2021-06-11
Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-06-19
2020-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
After obtaining a baseline sample of 5 mL of blood, 1 mL of I-131-labeled albumin will be injected intravenously over 1 min. At the time the baseline sample is obtained, a hematocrit will be simultaneously acquired. Five milliliter blood samples will then be collected at 12, 18, 24, 30, and 36 min post-injection, and the Plasma volume (PV) will be measured by extrapolating to time zero. This entire process will occur twice per patient: once pre-procedure and once post-procedure.
OTHER
NONE
Study Groups
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Blood volume assessment with Blood Volume Analyzer
Injections of 1 mL of I-131-labeled serum albumin based on each patient's height and weight - 1 pre-surgical and 1 post-surgical
Radioisotope I-131-labeled albumin
1 mL of radioisotope I-131-labeled albumin x 2
Interventions
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Radioisotope I-131-labeled albumin
1 mL of radioisotope I-131-labeled albumin x 2
Eligibility Criteria
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Inclusion Criteria
* Surgery scheduled for posterior spinal fusion correction of idiopathic scoliosis
Exclusion Criteria
* Known coagulopathy or platelet dysfunction
10 Years
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Nicholas Fletcher
Associate Professor
Principal Investigators
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Nicholas Fletcher
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00101023
Identifier Type: -
Identifier Source: org_study_id
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