Using ARISTA-AH to improve bleeding control after spinal fusion surgery
Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
This study tests if a product called ARISTA-AH can help reduce bleeding during and after spinal fusion surgery for patients needing surgery on at least five vertebrae.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Polyclinique Bordeaux Nord Aquitaine Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05323448 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of ARISTA-AH in restoring hemostasis in patients undergoing long-segment posterior spinal fusion. Participants will be randomly assigned to receive either ARISTA-AH or no treatment during their surgery. The study will include patients who require surgery on at least five adjacent vertebrae and will utilize a surgical drain. The aim is to determine if ARISTA-AH can significantly reduce bleeding complications during and after the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults eligible for posterior lumbar or thoraco-lumbar long-segment spinal fusion involving at least five adjacent vertebrae.
Not a fit: Patients under 18, those with known hemostatic disorders, or individuals with contraindications to ARISTA-AH will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved surgical outcomes and reduced complications related to bleeding in spinal fusion surgeries.
How similar studies have performed: While there is ongoing research into hemostatic agents in surgical settings, the specific use of ARISTA-AH in spinal fusion is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion. 2. Surgery targeting at least 5 adjacent vertebra combined with one of the following procedure: 1. Intersomatic bone graft; 2. Pedicle substraction osteotomy; 3. Any other intervertebral osteotomy (e.g. Smith-Petersen osteotomy); 3. The use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible); Exclusion Criteria: 1. Subject under the age of 18 years old; 2. Subject with a known haemostatic disorder; 3. Subject with any infection or any immune system disorder; 4. Subject not eligible to a posterior spinal surgery; 5. Subject with a known allergy or any contraindication to the use of the study device; 6. Currently pregnant or planning pregnancy; 7. Prisoner or a ward of the state; 8. Subject no willing to participate in the study; 9. Subject not affiliated to a social security insurance.
Where this trial is running
Bordeaux
- Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Jean Charles LE HUEC, M.D., PhD — VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
- Study coordinator: Stéphane BOURRET
- Email: s.bourret@bordeauxnord.com
- Phone: +33556437017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.