Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990376
• Other study ID #: IRB00101023
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: September 10, 2020

Study information

• Verified date: June 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Hemorrhage
• Scoliosis

Intervention

Other:
• Radioisotope I-131-labeled albumin
1 mL of radioisotope I-131-labeled albumin x 2

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta - Egleston Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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	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)