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NCT Number: NCT03990376

Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss

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

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Key information

Conditions

Adolescent Idiopathic Scoliosis Bone Diseases Hemorrhage Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Scoliosis Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta - Egleston Hospital

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radioisotope I-131-labeled albumin

Other

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

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

    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.

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

    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.

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

    Time frame: Immediately after surgery (closing of incision)

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2019
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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