Adolescent Idiopathic ScoliosisNCT03990376
Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss
A study testing Radioisotope I-131-labeled albumin in people with Adolescent Idiopathic Scoliosis, run by Emory University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Radioisotope I-131-labeled albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 10 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 10-17 years old
- Surgery scheduled for posterior spinal fusion correction of idiopathic scoliosis
Who cannot join
- Congenital or neuromuscular scoliosis
- Known coagulopathy or platelet dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, 30322
About this study
Official title: Establishment of a Gold Standard Formula for Blood Loss Calculation in Adolescent Idiopathic Scoliosis (AIS) Surgery
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
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Radioisotope I-131-labeled albumin
- Keywords
- Scoliosis, Pediatric surgery, Orthopedics, Blood loss
- Medical subject headings
- Scoliosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioisotope I-131-labeled albuminOther
1 mL of radioisotope I-131-labeled albumin x 2
| Study group | Role | What they receive |
|---|---|---|
| Blood volume assessment with Blood Volume Analyzer | Other | 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 Receives: Other: Radioisotope I-131-labeled albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Blood loss will be assessed immediately after surgery (closing of incision)
Secondary outcomes (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
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.
Measured: Blood volume will be measured at the beginning of surgery (immediately after anesthetic induction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start19 Jun 2019
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Fletcher, Emory University
- Investigators
- Nicholas Fletcher, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990376
- Sponsor's protocol ID
- IRB00101023
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2019
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Gold Standard Formula for Blood Loss Calculation in Adolescent Idiopathic Scoliosis (AIS) Surgery
- ClinicalTrials.gov ID
- NCT03990376
- Acronym / sponsor ID
- IRB00101023
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Pediatric surgery, Orthopedics, Blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blood volume assessment with Blood Volume Analyzer | Other | Other: Radioisotope I-131-labeled albuminInjections of 1 mL of I-131-labeled serum albumin based on each patient's height and weight - 1 pre-surgical and 1 post-surgical |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 10-17 years old
- Surgery scheduled for posterior spinal fusion correction of idiopathic scoliosis
Key exclusion criteria (2 listed)
- Congenital or neuromuscular scoliosis
- Known coagulopathy or platelet dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioisotope I-131-labeled albumin1 mL of radioisotope I-131-labeled albumin x 2 | Other | Blood volume assessment with Blood Volume Analyzer |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Fletcher principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radioisotope I-131-labeled albumin in people with Adolescent Idiopathic Scoliosis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Blood loss will be assessed immediately after surgery (closing of incision)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.