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Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03990376
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Nicholas Fletcher, Emory University

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

Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Other: Radioisotope I-131-labeled albumin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Scoliosis

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Nicholas Fletcher 404-778-3831 nicholas.d.fletcher@emory.edu

Locations
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United States, Georgia
Children's Healthcare of Atlanta - Egleston Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Nicholas Fletcher    404-778-3831    nicholas.d.fletcher@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Nicholas Fletcher Emory University
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Responsible Party: Nicholas Fletcher, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03990376    
Other Study ID Numbers: IRB00101023
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nicholas Fletcher, Emory University:
Scoliosis
Pediatric surgery
Orthopedics
Blood loss
Additional relevant MeSH terms:
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Scoliosis
Hemorrhage
Pathologic Processes
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases