NCT05323448

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 25, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

March 24, 2022

Last Update Submit

April 9, 2026

Conditions

HemostaticsHemostasisSpinal DeformitySpinal Fusion

Keywords

ARISTA-TMPosterior Spinal FusionSpinal surgerySpinal deformityHemostasis

Outcome Measures

Primary Outcomes (1)

  • Blood loss within the first 24 hours after posterior spinal fusion

    Blood loss calculated in ml per number of instrumented vertebra

    24 hours

Secondary Outcomes (13)

  • Blood loss within the first 6 hours after posterior spinal fusion

    6 hours

  • Blood loss within the first 48 hours after posterior spinal fusion

    48 hours

  • Total post-operative blood loss

    3 Days

  • Estimated Blodd Loss (EBL)

    7 Days

  • Hidden Blood Loss (HBL)

    7 Days

  • +8 more secondary outcomes

Study Arms (2)

ARISTA

EXPERIMENTAL

ARISTA-AH will be applied directly within the wound before closure.

Device: ARISTA

Control group

EXPERIMENTAL

Participant will not receive the ARISTA-AH hemostatic agent.

Device: Control Group

Interventions

Control GroupDEVICE

During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).

Control group
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

ARISTA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;
  • Prisoner or a ward of the state;
  • Subject no willing to participate in the study;
  • Subject not affiliated to a social security insurance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jean Charles LE HUEC, M.D., PhD

    VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 12, 2022

Study Start

October 25, 2022

Primary Completion

March 9, 2025

Study Completion

July 1, 2025

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)