Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss

Emory University

Status: Completed

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Other: Radioisotope I-131-labeled albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT03990376

IRB00101023

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Blood volume assessment with Blood Volume Analyzer

Other group

Description:

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

Treatment:

Other: Radioisotope I-131-labeled albumin