Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss

Not Applicable

Completed

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Other: Radioisotope I-131-labeled albumin

• Registration Number: NCT03990376
• Lead Sponsor: Emory University

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

Detailed Description

Bleeding is a necessary and unavoidable part of spine surgery. It is important to the surgeons and anesthesiologists to know how much blood a patient has lost during surgery in order to care for them in the best way possible. Different methodology has been employed to estimate how much blood is lost during surgery, but unfortunately none of the methods used have been reliable. The study will calculate surgical blood loss by determining perioperative change in red cell volume that is directly measured by using a special method that relies on radioisotope I-131-labeled albumin administration (BVA-100) during the surgery. This benchmarked blood loss estimate will then be compared to estimates calculated using the Gross equation, the Bourke and Smith equation, and the Camarasa formula. In addition, blood loss will be estimated volumetrically by utilizing formulas based on the amount of salvaged blood produced by an intraoperative salvaging system (Cell Saver®). Blood loss estimates based on salvaged blood volume will also be compared to the benchmark.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-17
• Study Start: 2019-06-19
• Study First Posted: 2019-06-19
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

• Congenital or neuromuscular scoliosis
• Known coagulopathy or platelet dysfunction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood volume assessment with Blood Volume Analyzer	Radioisotope I-131-labeled albumin	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

Primary Outcome Measures

Name	Time	Method
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	Blood loss will be assessed immediately after surgery (closing of incision)	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.

Secondary Outcome Measures

Name	Time	Method
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)	The established blood volume estimators include Moore's formula, Nadler's formula, and the International Council for Standardization in Haematology (ICSH) equation. The BVA-100 blood volume estimate and all of the established blood volume estimators will estimate blood volume in mLs. Thus, the change in preoperative blood volume between the BVA-100 estimate and each of the established blood volume estimators will also be in mLs.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta - Egleston Hospital; 🇺🇸 Atlanta, Georgia, United States