Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss

June 9, 2021 updated by: Nicholas Fletcher, Emory University

Establishment of a Gold Standard Formula for Blood Loss Calculation in Adolescent Idiopathic Scoliosis (AIS) Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta - Egleston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital or neuromuscular scoliosis
  • Known coagulopathy or platelet dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: Radioisotope I-131-labeled albumin
1 mL of radioisotope I-131-labeled albumin x 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Blood loss will be assessed immediately after surgery (closing of incision)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Blood volume will be measured at the beginning of surgery (immediately after anesthetic induction)

Other Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Immediately after surgery (closing of incision)
Immediately after surgery (closing of incision)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Nicholas Fletcher, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Actual)

September 10, 2020

Study Completion (Actual)

September 10, 2020

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00101023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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