Contact Activation of Coagulation in Newly Inserted Central Venous Catheters

Summary

A central venous catheter (CVC) is a thin plastic tube placed into one of the body's large veins, typically in the neck or near the clavicle. CVCs are crucial for administering medications, fluids, and secure blood samples. Although CVCs are an essential tool in healthcare, there are certain risks and complications associated with their use. CVCs can affect the body's coagulation system, potentially leading to the formation of blood clots at the site of the catheter. This can result in serious complications, and in some cases, increased morbidity and mortality. Despite the known risk of blood clot formation with catheter use, it is still do not fully understand why clots occur or how a newly inserted catheter affects the coagulation system.

The aim of this randomized controlled trial is to compare four different central venous catheters and their impact on the coagulation system.

Eighty eight patients ≥18 years of age, who require a CVC and agree to participate in the study will be randomly assigned to one of the four predetermined, commonly used, central venous catheters. Two blood samples will be taken from the newly inserted catheter. The first blood sample (Sample 1) will be collected within seconds after catheter insertion without pre-flushing the catheter with saline. The second blood sample (Sample 2) will be taken after the catheter has been flushed with at least 10 ml saline and the initial blood discarded. All samples will be taken from the distale lumen without any connectors. Samples 1 and 2 will then be analyzed to measure how the coagulation system is affected after contact with the inside surface of the CVC. The blood samples will also be compared between the different catheter types and in overall cohort irrespective of group .

The study could provide valuable information on how the coagulation system is affected after catheter insertion. This knowledge could help improve preventive measures to reduce the risk of blood clot formation and ensure safer blood sampling for patients with venous catheters.

Conditions

• Central Venous Catheter
• Coagulation
• Coagulation Activation
• Central Venous Catheter Complications

Interventions

DEVICE

MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter

7 Fr, 150 mm, radio-opaque polyurethane catheter (OD 2.4 mm)

DEVICE

ARROW Two-Lumen Central Venous Catheter

7 Fr, 160 mm, radio-opaque polyurethane catheter (OD 2.5 mm)

DEVICE

ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter

8 Fr, 160 mm, radio-opaque polyurethane catheter with antimicrobial coating

DEVICE

Multicath 2 Expert UP Two-Lumen Central Venous Catheter

7.5 Fr, 160 mm, central venous catheter (OD 2.5 mm). Polyurethane shaft embedded with silver ions.

Sponsors & Collaborators

• Lund University

  collaborator OTHER

• Thomas Kander

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-10

Primary Completion

2026-12-30

Completion

2026-12-30

Countries

• Sweden

Study Locations