Back to resultsEfficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
Primary Purpose
Hemostatics, Hemostasis, Spinal Deformity
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control Group
ARISTA
Sponsored by
About this trial
This is an interventional treatment trial for Hemostatics focused on measuring ARISTA-TM, Posterior Spinal Fusion, Spinal surgery, Spinal deformity, Hemostasis
Eligibility Criteria
Inclusion Criteria:
- 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);
Exclusion Criteria:
- 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.
Sites / Locations
- Polyclinique Bordeaux Nord AquitaineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ARISTA
Control group
Arm Description
ARISTA-AH will be applied directly within the wound before closure.
Participant will not receive the ARISTA-AH hemostatic agent.
Outcomes
Primary Outcome Measures
Blood loss within the first 24 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Secondary Outcome Measures
Blood loss within the first 6 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Blood loss within the first 48 hours after posterior spinal fusion
Blood loss calculated in ml per number of instrumented vertebra
Total post-operative blood loss
Cumulative blood loss observed until surgical drain removal
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
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
Drain removal
Delay between the date of initial surgery and the date of surgical drain removal
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
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).
Assessment of the Oswestry Disability Index
Change from baseline in self reported Oswestry Disability Index (ODI) score at 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.
Length of stay
Length of stay is the delay between the date of admission and the date of discharge for each patient.
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.
Incidence of any serious adverse events
Record of any intra and postoperative complications
Full Information
NCT ID
NCT05323448
First Posted
March 24, 2022
Last Updated
March 15, 2023
Sponsor
Polyclinique Bordeaux Nord Aquitaine
Collaborators
Bard Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05323448
Brief Title
Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
Official Title
Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polyclinique Bordeaux Nord Aquitaine
Collaborators
Bard Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemostatics, Hemostasis, Spinal Deformity, Spinal Fusion
Keywords
ARISTA-TM, Posterior Spinal Fusion, Spinal surgery, Spinal deformity, Hemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARISTA
Arm Type
Experimental
Arm Description
ARISTA-AH will be applied directly within the wound before closure.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Participant will not receive the ARISTA-AH hemostatic agent.
Intervention Type
Device
Intervention Name(s)
Control Group
Intervention Description
During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).
Intervention Type
Device
Intervention Name(s)
ARISTA
Intervention Description
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
Primary Outcome Measure Information:
Title
Blood loss within the first 24 hours after posterior spinal fusion
Description
Blood loss calculated in ml per number of instrumented vertebra
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Blood loss within the first 6 hours after posterior spinal fusion
Description
Blood loss calculated in ml per number of instrumented vertebra
Time Frame
6 hours
Title
Blood loss within the first 48 hours after posterior spinal fusion
Description
Blood loss calculated in ml per number of instrumented vertebra
Time Frame
48 hours
Title
Total post-operative blood loss
Description
Cumulative blood loss observed until surgical drain removal
Time Frame
3 Days
Title
Estimated Blodd Loss (EBL)
Description
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
Time Frame
7 Days
Title
Hidden Blood Loss (HBL)
Description
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
Time Frame
7 Days
Title
Drain removal
Description
Delay between the date of initial surgery and the date of surgical drain removal
Time Frame
7 Days
Title
Detection of any early post-operative haematoma
Description
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
Time Frame
7 Days
Title
Improvement of back and leg pains at 3 months compared to preoperative scores
Description
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).
Time Frame
3 months
Title
Assessment of the Oswestry Disability Index
Description
Change from baseline in self reported Oswestry Disability Index (ODI) score at 3 months.
Time Frame
3 months
Title
Change in Patient's quality of life
Description
Change from baseline in self reported 12-Item Short Form Survey (SF-12) score at 3 months.
Time Frame
3 months
Title
Length of stay
Description
Length of stay is the delay between the date of admission and the date of discharge for each patient.
Time Frame
7 Days
Title
Detection of any haemostasis disorder
Description
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.
Time Frame
3 Months
Title
Incidence of any serious adverse events
Description
Record of any intra and postoperative complications
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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);
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane BOURRET
Phone
+33556437017
Email
s.bourret@bordeauxnord.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Boue
Phone
+33556437017
Email
l.boue@bordeauxnord.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Charles LE HUEC, M.D., PhD
Organizational Affiliation
VERTEBRA Institute, Polyclinique Bordeaux Nord Aquitaine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Bourret
Phone
+33556437017
Email
s.bourret@bordeauxnord.com
First Name & Middle Initial & Last Name & Degree
Lisa Boue
Phone
+33556437017
Email
l.boue@bordeauxnord.com
First Name & Middle Initial & Last Name & Degree
Jean Charles LE HUEC, M.D., PhD
First Name & Middle Initial & Last Name & Degree
Wendy THOMPSON, M.D.
First Name & Middle Initial & Last Name & Degree
Thibault CLOCHE, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
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