Safe-Infusion Study

NCT06727240 | Recruiting DMC

• 1 other identifier: Interlinked 05-01-11
• Study Type: interventional
• Target: 548
• Locations: 2 countries
• Sites: 2

Brief Summary

Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.

Conditions

Intravenous Access; Medical Device

Outcome Measures

Primary Outcomes (1)

• The rate of mechanical complications of an IV therapy session using the device compared to using current 'state of the art'.

  Mechanical complications are defied as following: * Phlebitis -inflammation of a vein based on clinical diagnosis * Infiltration - the process of accidental leakage of fluids out of the veins into peripheral tissue * Occlusion - blocked PIVC, where flushing or aspirating from the PIVC is not possible * Dislodgment - the process of accidental/ unintentional complete removal of the PIVC before scheduled removal

  Baseline PIVC data and immediatly after PIVC removal

Secondary Outcomes (3)

• Frequency and severity of any adverse events

  Through study participation (hospitlized in the ward), an average of 5 days

• Healthcare workers opinion of investigational device

  Immediately after the intervention

• The economic cost of these disruptions to your facility in terms of man-hours, and resources.

  Immediatly after PIVC removal

Study Arms (2)

ReLink®

EXPERIMENTAL

One or more investigational devices will be added to the infusion line. Standard practise procedure related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion.

Device: Intervention

Control

NO INTERVENTION

Standard practise related to PIVC infusions according to hospital norm will be followed. Thereafter the planned IV therapy is initiated until completion.

Interventions

Intervention DEVICE

The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.

ReLink®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to \<2h.
• ≥18 years of age
• Speak and understand local language
• VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion
• Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent

You may not qualify if:

• The VAD is expected to be used for sampling only
• Pregnancy
• Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
• Patients under palliative care
• Bolus IV infusion, defined as an infusion time of \<15 min

Sponsors & Collaborators

• Interlinked AB: lead
• Parc Sanitari Sant Joan de Déu: collaborator
• Unidade Local de Saúde de Coimbra, EPE: collaborator

Study Sites (2)

Centro Hospitalar e Universitário de Coimbra

Coimbra, 3000-075, Portugal

RECRUITING

Parc Sanitari Sant Joan de Déu

Barcelona, 08830, Spain

COMPLETED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ramon Mir Abellán, PhD

  Parc Sanitari Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

• António Manuel Marques, PhD

  Unidade Local de Saúde de Coimbra, EPE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Blacker, Medical Doctor

CONTACT

+46737301399; christopher.blacker@uu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 10, 2024
• Study Start: March 25, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1 year of study completion

Locations

ES (1); PT (1)