Clinical trial NCT03990376: Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss
Official title: Establishment of a Gold Standard Formula for Blood Loss Calculation in Adolescent Idiopathic Scoliosis (AIS) Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Pediatric surgery
Orthopedics
Blood loss
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants include 45 adolescent subjects undergoing spinal fusion for correction of idiopathic scoliosis.

After obtaining a baseline sample of 5 mL of blood, 1 mL of I-131-labeled albumin will be injected intravenously over 1 min. At the time the baseline sample is obtained, a hematocrit will be simultaneously acquired. Five milliliter blood samples will then be collected at 12, 18, 24, 30, and 36 min post-injection, and the Plasma volume (PV) will be measured by extrapolating to time zero. This entire process will occur twice per patient: once pre-procedure and once post-procedure.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Blood loss will be assessed immediately after surgery (closing of incision)
Secondary outcomes:
measure: 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
timeFrame: Blood volume will be measured at the beginning of surgery (immediately after anesthetic induction)
Other outcomes:
measure: 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
timeFrame: Immediately after surgery (closing of incision)
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Egleston Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Nicholas Fletcher
role: PRINCIPAL_INVESTIGATOR
References: