Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07014722

Contact Activation of Coagulation in Newly Inserted Central Venous Catheters

Led by Thomas Kander · Updated on 2026-02-18

88

Participants Needed

1

Research Sites

68 weeks

Total Duration

On this page

Sponsors

T

Thomas Kander

Lead Sponsor

L

Lund University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Contact Activation of Coagulation in Newly Inserted Central Venous Catheters

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical need for placement of a two-lumen central venous catheter measuring 150-160 mm
  • Age 18 years or older
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Current use of anticoagulants or platelet inhibitors, except prophylactic low molecular weight heparin or acetylsalicylic acid
  • Prothrombin complex (PT-INR) outside normal range (0.9-1.2), platelet count less than 50 x 10^9/L, or hemoglobin less than 80 g/L if known
  • Known coagulopathic conditions such as activated protein C resistance, hemophilia A or B, vitamin K deficiency, disseminated intravascular coagulation, antiphospholipid syndrome, von Willebrand disease, or other bleeding disorders

AI-Screening

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Trial Site Locations

Total: 1 location

1

Skåne University Hospital Lund

Lund, Skåne County, Sweden, 22242

Actively Recruiting

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Research Team

T

Thomas Kander, Professor

CONTACT

A

Aida Zorlak, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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