Status:
ACTIVE_NOT_RECRUITING
VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Midline Catheter
Orthopedic Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Our goal is to demonstrate how a standardized approach that involves the pre-operative implantation of the venous access devices in the DIVA patients (EA-DIVA score\> or =8), scheduled for orthopedic ...
Detailed Description
Prospective observational cost-effectiveness study. A preliminary evaluation of the EA-DIVA score of all patients who are candidates for surgery will be performed; all patients with an EA-DIVA score \...
Eligibility Criteria
Inclusion
- Patients of legal age (≥ 18 years).
- Patients with a history of documented venous difficulties (DIVA Score \> or = 8)
- Candidates for surgery in GA or LRA
- Patients who have signed the informed consent
Exclusion
- Patients under 18 years of age
- Patients with medical or anatomical contraindications to DAV placement in the upper limbs
- Local Contraindications: neuromuscular pathologies (long-standing paresis), osteoarticular (fractures, ankylosis), vascular (presence of active DVT affecting the basilar-subclavian-axillary axis), dermatological (infections, burns), lymphatic (axillary lymphadenectomy)
- Systemic Contraindications: chronic renal failure grade 3b-4-5, patients on periodic chronic hemodialysis or destined for dialysis, severe thrombocytopenia with platelet count \< a 50,000/mm3 (relative contraindication not valid for non-tunneled PICCs, midline and minimidline)
- Anatomical contraindications: deep veins of the arm of inadequate caliber for the device
Key Trial Info
Start Date :
March 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 21 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06904651
Start Date
March 5 2025
End Date
March 21 2026
Last Update
April 1 2025
Active Locations (1)
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1
IRCCS - Istituto Ortopedico Rizzoli Via di Barbiano 1/10 40136 Bologna Italy
Bologna, BO, Italy, 40133