Contact Activation of Coagulation in Newly Inserted Central Venous Catheters
Contact Activation of Coagulation in Newly Inserted Central Catheters - a Randomized Controlled Trial
Thomas Kander
88 participants
Sep 10, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Participants must meet all of the following criteria to be included in the study:
- Clinical indication for the placement of a two-lumen central venous catheter with length 150-160 mm.
- Age ≥18 years.
- Signed informed consent.
Exclusion Criteria10
- Participants meeting any of the following criteria will be excluded:
- Current use of anticoagulants or platelet inhibitors, except: Prophylactic low molecular weight heparin (LMWH), double prophylactic dose of LMWH, Acetylsalicylic acid (ASA).
- Prothrombin complex (pK/INR) outside the normal range (0.9-1.2), platelet count \<50 × 10⁹/L or haemoglobin \< 80 g/L, if already available.
- Known coagulopathic conditions, including but not limited to:
- Activated protein C (APC) resistance,
- Hemophilia A or B,
- Vitamin K deficiency,
- Disseminated intravascular coagulation (DIC),
- Antiphospholipid syndrome,
- von Willebrand disease, Other known congenital or acquired bleeding disorders.
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Interventions
7 Fr, 150 mm, radio-opaque polyurethane catheter (OD 2.4 mm)
7 Fr, 160 mm, radio-opaque polyurethane catheter (OD 2.5 mm)
8 Fr, 160 mm, radio-opaque polyurethane catheter with antimicrobial coating
7.5 Fr, 160 mm, central venous catheter (OD 2.5 mm). Polyurethane shaft embedded with silver ions.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07014722