Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss
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|ClinicalTrials.gov Identifier: NCT03990376|
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Other: Radioisotope I-131-labeled albumin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|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.
|Masking:||None (Open Label)|
|Official Title:||Establishment of a Gold Standard Formula for Blood Loss Calculation in Adolescent Idiopathic Scoliosis (AIS) Surgery|
|Actual Study Start Date :||June 19, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
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
- 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.
- 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.
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990376
|Contact: Nicholas Fletcherfirstname.lastname@example.org|
|United States, Georgia|
|Children's Healthcare of Atlanta - Egleston Hospital||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Nicholas Fletcher 404-778-3831 email@example.com|
|Principal Investigator:||Nicholas Fletcher||Emory University|