HemostaticsNCT05323448
Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
A study testing ARISTA in people with Hemostatics and Hemostasis, run by Polyclinique Bordeaux Nord Aquitaine at 1 site in France.
Trial summary
The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostatics, Hemostasis, Spinal Deformity
- What is being tested?
- ARISTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2022to 1 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion.
- Surgery targeting at least 5 adjacent vertebra combined with one of the following procedure:
- Intersomatic bone graft;
- Pedicle substraction osteotomy;
- Any other intervertebral osteotomy (e.g. Smith-Petersen osteotomy);
- The use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible);
Who cannot join
- Subject under the age of 18 years old;
- Subject with a known haemostatic disorder;
- Subject with any infection or any immune system disorder;
- Subject not eligible to a posterior spinal surgery;
- Subject with a known allergy or any contraindication to the use of the study device;
- Currently pregnant or planning pregnancy;
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- Prisoner or a ward of the state;
- Subject no willing to participate in the study;
- Subject not affiliated to a social security insurance.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.
Read the detailed description
After being informed about the study and potential risks, all patients giving written inform consent will be included in the study during their preoperative visit. After eligibility criteria checking and based on their respective surgical indication, participants will be randomized in a single-blinded and stratified manner (participant only) in a 1:1 ratio to ARISTA-AH or no ARISTA-AH. The stratification process will consider the number of instrumented vertebra during each surgery (level 1: 5 to 8 vertebra; level 2: 9 or more instrumented vertebra).
- Conditions
- Hemostatics, Hemostasis, Spinal Deformity, Spinal Fusion
- Being tested
- Control Group, ARISTA
- Keywords
- ARISTA-TM, Posterior Spinal Fusion, Spinal surgery, Spinal deformity, Hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupDevice
During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).
ARISTADevice
During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent). Before surgical wound closure, the corresponding amount of ARISTA-AH will be applied to completely cover the bleeding site :
- 5g for 5 to 8 instrumented vertebra
- 10g fo 9 or more instrumented vertebra
| Study group | Role | What they receive |
|---|---|---|
| ARISTA | Experimental | ARISTA-AH will be applied directly within the wound before closure. Receives: Device: ARISTA |
| Control group | Experimental | Participant will not receive the ARISTA-AH hemostatic agent. Receives: Device: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss within the first 24 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Measured: 24 hours
Secondary outcomes (13)
Blood loss within the first 6 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Measured: 6 hours
Blood loss within the first 48 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Measured: 48 hours
Total post-operative blood loss
Cumulative blood loss observed until surgical drain removal
Measured: 3 Days
Estimated Blodd Loss (EBL)
EBL are calculated by multiplying the perioperative difference of haemoglobin EHb (formula used: EHb = (Hb preop - Hb post-op)/Hb preop) by the patient's estimated blood volume (EBV = weight x F; F = 75 for adult males; F = 70 for adolescent males; F = 60 for females).
EBL = EHb x EBV
Measured: 7 Days
Hidden Blood Loss (HBL)
HBL is the difference of the estimated blood loss (EBL) with the amount of perioperative blood loss and the amount of transfusions:
HBL = EBL - intraoperative blood loss + transfusion
Measured: 7 Days
Drain removal
Delay between the date of initial surgery and the date of surgical drain removal
Measured: 7 Days
Detection of any early post-operative haematoma
Every participant will have an early postoperative MRI (before hospital discharge) to detect the presence of any haematoma.
The presence (yes/no), the size (cm2) and the gravity (symptomatic, asymptomatic) of the observed haematoma will be compared between the 2 groups
Measured: 7 Days
Improvement of back and leg pains at 3 months compared to preoperative scores
Back and leg pain intensity self-report will be assessed before and after initial procedure for each patient (at 3 months) using a 0 to 10 visual analog scale (0: no pain ; 10: most imaginable pain).
Measured: 3 months
Assessment of the Oswestry Disability Index
Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 months.
Measured: 3 months
Change in Patient's quality of life
Change from baseline in self reported 12-Item Short Form Survey (SF-12) score at 3 months.
Measured: 3 months
Length of stay
Length of stay is the delay between the date of admission and the date of discharge for each patient.
Measured: 7 Days
Detection of any haemostasis disorder
Proportion of subjects with any of the following complications related to haemostasis condition: delay or healing disorders, post-operative wound infection, neurological disorders, surgical disorders or any other complication directly related to haemostasis dysfunction or the use of ARISTA-AH product.
Measured: 3 Months
Incidence of any serious adverse events
Record of any intra and postoperative complications
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start25 Oct 2022
- Primary completion9 Mar 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostaticsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyclinique Bordeaux Nord Aquitaine
- Sponsor type
- University, hospital or other
- Collaborators
- Bard Ltd
- Responsible party
- Sponsor
- Investigators
- Jean Charles LE HUEC, M.D., PhD, Principal investigator, VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323448
- Sponsor's protocol ID
- 2022-ORT01
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
- ClinicalTrials.gov ID
- NCT05323448
- Acronym / sponsor ID
- 2022-ORT01
- Conditions
- Hemostatics, Hemostasis, Spinal Deformity, Spinal Fusion
- Keywords
- ARISTA-TM, Posterior Spinal Fusion, Spinal surgery, Spinal deformity, Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Polyclinique Bordeaux Nord AquitaineUniversity, hospital or other
- Collaborators
- Bard Ltd
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 9 Mar 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 12 Apr 2022 (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 aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.
Detailed description
After being informed about the study and potential risks, all patients giving written inform consent will be included in the study during their preoperative visit. After eligibility criteria checking and based on their respective surgical indication, participants will be randomized in a single-blinded and stratified manner (participant only) in a 1:1 ratio to ARISTA-AH or no ARISTA-AH. The stratification process will consider the number of instrumented vertebra during each surgery (level 1: 5 to 8 vertebra; level 2: 9 or more instrumented vertebra).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARISTA | Experimental | Device: ARISTAARISTA-AH will be applied directly within the wound before closure. |
| Control group | Experimental | Device: Control GroupParticipant will not receive the ARISTA-AH hemostatic agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion.
- Surgery targeting at least 5 adjacent vertebra combined with one of the following procedure:
- The use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible);
Key exclusion criteria (9 listed)
- Subject under the age of 18 years old;
- Subject with a known haemostatic disorder;
- Subject with any infection or any immune system disorder;
- Subject not eligible to a posterior spinal surgery;
- Subject with a known allergy or any contraindication to the use of the study device;
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 |
|---|---|---|
| Control GroupDuring the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent). | Device | Control group |
| ARISTADuring the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent). Before surgical wound closure, the corresponding amount of ARISTA-AH will be applied to completely cover the bleeding site : * 5g for 5 to 8 instrumented vertebra * 10g fo 9 or more instrumented vertebra | Device | ARISTA |
Primary outcome
Blood loss within the first 24 hours after posterior spinal fusion
Time frame: 24 hours
Blood loss calculated in ml per number of instrumented vertebra
13 secondary outcomes
Blood loss within the first 6 hours after posterior spinal fusion
Time frame: 6 hours
Blood loss within the first 48 hours after posterior spinal fusion
Time frame: 48 hours
Total post-operative blood loss
Time frame: 3 Days
Estimated Blodd Loss (EBL)
Time frame: 7 Days
Hidden Blood Loss (HBL)
Time frame: 7 Days
Drain removal
Time frame: 7 Days
Detection of any early post-operative haematoma
Time frame: 7 Days
Improvement of back and leg pains at 3 months compared to preoperative scores
Time frame: 3 months
Assessment of the Oswestry Disability Index
Time frame: 3 months
Change in Patient's quality of life
Time frame: 3 months
Length of stay
Time frame: 7 Days
Detection of any haemostasis disorder
Time frame: 3 Months
Incidence of any serious adverse events
Time frame: 3 Months
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 14 Apr 2026.
- 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.
Jean Charles LE HUEC, M.D., PhD principal investigator
VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARISTA in people with Hemostatics and Hemostasis, run by Polyclinique Bordeaux Nord Aquitaine at 1 site in France.
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 6 inclusion and 9 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 14 Apr 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 France. 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?
Blood loss within the first 24 hours after posterior spinal fusion (time frame: 24 hours). 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 14 Apr 2026.