Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss

NCT03990376 | Completed

• 1 other identifier: IRB00101023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish a benchmark for measuring blood loss by directly measuring the change in red cell volume before and after surgery and to compare established blood loss estimators to this benchmark in order to determine the most accurate and precise method for estimating blood loss in adolescent idiopathic scoliosis surgery patients

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis; Pediatric surgery; Orthopedics; Blood loss

Outcome Measures

Primary Outcomes (1)

• The change in blood loss (in mLs) determined by the benchmark technique (directly measured red cell volume loss by BVA-100 Blood Volume Analyzer divided by average intraoperative hematocrit) and each of an established set of blood loss estimators

  The established blood loss estimators include the Gross equation, the Bourke and Smith equation, the Camarasa formula, and equations based on salvaged blood volumes (e.g. 2x cell saver volume). The benchmark blood loss estimate and all of the established blood loss estimators will estimate blood loss in mLs. Thus, the change in surgical blood loss between the benchmark estimator and each of the established blood loss estimators will also be in mLs.

  Blood loss will be assessed immediately after surgery (closing of incision)

Secondary Outcomes (1)

• The change in pre-surgical blood volume (in mLs) directly measured by the BVA-100 Blood Volume Analyzer and each of an established set of blood volume estimators

  Blood volume will be measured at the beginning of surgery (immediately after anesthetic induction)

Other Outcomes (1)

• The ratio of red blood cell volume recovered by an intraoperative blood salvaging system (Cell Saver®) and the red cell volume lost (determined by BVA-100 Blood Volume Analyzer) during the surgery

  Immediately after surgery (closing of incision)

Study Arms (1)

Blood volume assessment with Blood Volume Analyzer

OTHER

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

Other: Radioisotope I-131-labeled albumin

Interventions

Radioisotope I-131-labeled albumin OTHER

1 mL of radioisotope I-131-labeled albumin x 2

Blood volume assessment with Blood Volume Analyzer

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 10-17 years old
• Surgery scheduled for posterior spinal fusion correction of idiopathic scoliosis

You may not qualify if:

• Congenital or neuromuscular scoliosis
• Known coagulopathy or platelet dysfunction

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta - Egleston Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Scoliosis; Hemorrhage

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Fletcher

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants include 45 adolescent subjects undergoing spinal fusion for correction of idiopathic scoliosis. 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.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 19, 2019
• Study Start: June 19, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)