NCT02197013

Brief Summary

Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

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

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

July 17, 2014

Last Update Submit

August 2, 2023

Conditions

Patients in Need for Intravenous Access

Outcome Measures

Primary Outcomes (1)

  • Frequency and time of occurence of blood leakage

    Within one minute

Secondary Outcomes (2)

  • Problems during catheter insertion and fixation of Introcan Safety 3

    During insertion and fixation of catheter

  • Necessity of disconnection of catheter

    During catheter placement

Study Arms (2)

Introcan Safety 3

Closed IV Catheter

Introcan Safety

IV catheter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in need for intravenous access

You may qualify if:

  • need for intravenous access

You may not qualify if:

  • n. a.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH (KKRN)

Dorsten, Germany

Location

Study Officials

  • Gertrud Haeseler, Prof.

    KKRN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 22, 2014

Study Start

September 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations

DE(1)