Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood LossNCT07661589
Blood Transfusion Risk Factors and Cell Saver Impact in Pediatric Scoliosis Surgery
An observational study of Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss, run by Mehdi Trifa at 1 site in Tunisia.
Trial summary
Spine surgery for scoliosis correction in pediatric patients is a major procedure associated with a high risk of perioperative blood loss. Homologous blood transfusion carries inherent risks, including immunological reactions, infections, and increased healthcare costs. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss
- What is being tested?
- posterior Instrumented Spinal Fusion and Intraoperative Cell Saver Autologous Reinfusion
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of pediatric patients under 18 years of age who underwent major orthopedic spine surgery for scoliosis correction at a single specialized tertiary center. The cohort includes individuals with various scoliosis etiologies-such as idiopathic, neuromuscular, and congenital scoliosis-who required instrumented posterior spinal arthrodesis. Patients are selected from the institutional surgical registry over a continuous 3-year period (from April 2023 to March 2026)
Who may be able to join
- Patient aged under 18 years (< 18 years old).
- Programmed surgical correction for scoliosis (including idiopathic, neuromuscular, and congenital etiologies).
- Instrumented surgery involving posterior spinal arthrodesis.
Who cannot join
- Revision spine surgeries.
- Known constitutional hemostasis disorders.
- Non-orthopedic spine surgeries.
- Missing core clinical or transfusion data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Bechir Hamza Children Hospital
Tunis
Mehdi Trifa, Professor, +21698135697, mehdi.trifa@gmail.com
About this study
Official title: Risk Factors for Homologous Blood Transfusion and Impact of Cell Saver Use in Pediatric Scoliosis Surgery: A Retrospective Monocentric Study
Spine surgery for scoliosis correction in pediatric patients is a major procedure associated with a high risk of perioperative blood loss. Homologous blood transfusion carries inherent risks, including immunological reactions, infections, and increased healthcare costs. Identifying high-risk patients is crucial to optimize blood conservation strategies. This retrospective study aims to identify preoperative and intraoperative risk factors associated with homologous red blood cell (RBC) transfusion and to evaluate the quantitative impact of Cell Saver volume reinfusion on reducing homologous transfusion requirements.
- Being tested
- posterior Instrumented Spinal Fusion, Intraoperative Cell Saver Autologous Reinfusion
- Keywords
- Pediatric scoliosis, Cell Saver, Homologous blood transfusion, Risk factors, Spine surgery, Posterior spinal fusion
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior Instrumented Spinal FusionProcedure or surgery
Standard surgical correction of scoliosis via a posterior approach with spinal instrumentation and arthrodesis, performed under general anesthesia
Intraoperative Cell Saver Autologous ReinfusionDevice
Use of an intraoperative autologous blood salvage device (Cell Saver) during spine surgery. Collected blood is washed, filtered, and reinfused to the patient peroperatively to reduce the need for homologous blood transfusion.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Scoliosis Cohort | Pediatric patients under 18 years old who underwent posterior instrumented spinal fusion for scoliosis correction (idiopathic, neuromuscular, or congenital) between April 2023 and March 2026. This single cohort is evaluated retrospectively to identify risk factors for homologous blood transfusion and to assess the impact of intraoperative Cell Saver use Receives: Procedure: posterior Instrumented Spinal Fusion; Device: Intraoperative Cell Saver Autologous Reinfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring perioperative homologous Red Blood Cell (RBC) transfusion
Measured: : From the start of surgery (anesthesia induction) up to postoperative day 3 (Day 0 to Day 3).
Secondary outcomes (2)
Blood conservation rate achieved by intraoperative autologous blood salvage
Measured: Intraoperative period (from skin incision to skin closure)
Total volume of homologous Red Blood Cells (RBC) transfused.
Measured: From the start of surgery up to postoperative day 3 (Day 0 to Day 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Apr 2023
- Primary completion2 Mar 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood LossStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehdi Trifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehdi Trifa, Tunis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661589
- Sponsor's protocol ID
- 26/2026
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Homologous Blood Transfusion and Impact of Cell Saver Use in Pediatric Scoliosis Surgery: A Retrospective Monocentric Study
- ClinicalTrials.gov ID
- NCT07661589
- Acronym / sponsor ID
- 26/2026
- Keywords
- Pediatric scoliosis, Cell Saver, Homologous blood transfusion, Risk factors, Spine surgery, Posterior spinal fusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mehdi TrifaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2026 (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.
Spine surgery for scoliosis correction in pediatric patients is a major procedure associated with a high risk of perioperative blood loss. Homologous blood transfusion carries inherent risks, including immunological reactions, infections, and increased healthcare costs. Identifying high-risk patients is crucial to optimize blood conservation strategies. This retrospective study aims to identify preoperative and intraoperative risk factors associated with homologous red blood cell (RBC) transfusion and to evaluate the quantitative impact of Cell Saver volume reinfusion on reducing homologous transfusion requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Scoliosis Cohort | – | Procedure: posterior Instrumented Spinal Fusion, Device: Intraoperative Cell Saver Autologous ReinfusionPediatric patients under 18 years old who underwent posterior instrumented spinal fusion for scoliosis correction (idiopathic, neuromuscular, or congenital) between April 2023 and March 2026. This single cohort is evaluated retrospectively to identify risk factors for homologous blood transfusion and to assess the impact of intraoperative Cell Saver use |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of pediatric patients under 18 years of age who underwent major orthopedic spine surgery for scoliosis correction at a single specialized tertiary center. The cohort includes individuals with various scoliosis etiologies-such as idiopathic, neuromuscular, and congenital scoliosis-who required instrumented posterior spinal arthrodesis. Patients are selected from the institutional surgical registry over a continuous 3-year period (from April 2023 to March 2026)
Key inclusion criteria (3 listed)
- Patient aged under 18 years (< 18 years old).
- Programmed surgical correction for scoliosis (including idiopathic, neuromuscular, and congenital etiologies).
- Instrumented surgery involving posterior spinal arthrodesis.
Key exclusion criteria (4 listed)
- Revision spine surgeries.
- Known constitutional hemostasis disorders.
- Non-orthopedic spine surgeries.
- Missing core clinical or transfusion data.
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 |
|---|---|---|
| posterior Instrumented Spinal FusionStandard surgical correction of scoliosis via a posterior approach with spinal instrumentation and arthrodesis, performed under general anesthesia | Procedure or surgery | Pediatric Scoliosis Cohort |
| Intraoperative Cell Saver Autologous ReinfusionUse of an intraoperative autologous blood salvage device (Cell Saver) during spine surgery. Collected blood is washed, filtered, and reinfused to the patient peroperatively to reduce the need for homologous blood transfusion. | Device | Pediatric Scoliosis Cohort |
Primary outcome
Proportion of patients requiring perioperative homologous Red Blood Cell (RBC) transfusion
Time frame: : From the start of surgery (anesthesia induction) up to postoperative day 3 (Day 0 to Day 3).
2 secondary outcomes
Blood conservation rate achieved by intraoperative autologous blood salvage
Time frame: Intraoperative period (from skin incision to skin closure)
Total volume of homologous Red Blood Cells (RBC) transfused.
Time frame: From the start of surgery up to postoperative day 3 (Day 0 to Day 3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss, run by Mehdi Trifa at 1 site in Tunisia.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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 Tunisia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rym Karaborni (0021651870732, karabornirym@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients requiring perioperative homologous Red Blood Cell (RBC) transfusion (time frame: : From the start of surgery (anesthesia induction) up to postoperative day 3 (Day 0 to Day 3).). 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 22 Jun 2026.