BIP CVC Clinical Safety and Performance Study

NCT02811380 | Completed Phase 4 DMC

• 1 other identifier: 2535-2030-CDOC
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.

Conditions

Surgery; Central Line Associated Blood Stream Infections (CLABSI)

Keywords

CVC; Healthcare associated infections (HAI); CLABSI; Noble metal alloy coating; CVC related thrombosis

Outcome Measures

Primary Outcomes (1)

• Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.

  Overall assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.

  Through study completion, an average of 10 days

Secondary Outcomes (1)

• Assessment of the overall performance

  Through study completion, an average of 10 days

Study Arms (2)

BIP CVC

EXPERIMENTAL

Bactiguard Infection Protection Central Venous Catheter

Device: BIP CVC

Uncoated standard CVC

PLACEBO COMPARATOR

Uncoated standard Central Venous Catheter

Device: Uncoated Standard CVC

Interventions

BIP CVC DEVICE

BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery

Also known as: BIP Central Venous Catheter, Bactiguard coated CVC, Noble metal alloy coated Central Venous Catheter

BIP CVC

Uncoated Standard CVC DEVICE

Standard CVC catheterization for venous access during and after elective large surgery

Also known as: Standard CVC, Standard Central Venous Catheter, Uncoated CVC, Uncoated Central Venous Catheter

Uncoated standard CVC

Eligibility Criteria

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

You may qualify if:

• Adult men and women ≥ 18 years of age
• Were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial
• Requiring CVC catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days
• Had signed the informed consent

You may not qualify if:

• Known transmissive blood disease
• Known multiresistant bacterial colonization
• Ongoing infection
• Thromboembolism
• Anti-coagulation treatment excluding prophylaxis
• CVC during last 2 months
• History of problems with CVC
• Pregnancy

Sponsors & Collaborators

• Bactiguard AB: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden

Stockholm, Huddinge, SE-141 86, Sweden

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigridur Kalman, MD PhD Prof

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: June 23, 2016
• Study Start: September 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 23, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)