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.
Clinical indication for the placement of a two-lumen central venous catheter with length 150-160 mm.
Age ≥18 years.
Signed informed consent.
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.
Activated protein C (APC) resistance,
Hemophilia A or B,
Parallel
MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter
Device7 Fr, 150 mm, radio-opaque polyurethane catheter (OD 2.4 mm)
ARROW Two-Lumen Central Venous Catheter
Device7 Fr, 160 mm, radio-opaque polyurethane catheter (OD 2.5 mm)
ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter
Device8 Fr, 160 mm, radio-opaque polyurethane catheter with antimicrobial coating
Multicath 2 Expert UP Two-Lumen Central Venous Catheter
Device7.5 Fr, 160 mm, central venous catheter (OD 2.5 mm). Polyurethane shaft embedded with silver ions.
Change in ROTEM NATEM Clotting Time (CT) (seconds) between Sample 1 and Sample 2
The primary endpoint is the difference in clotting time (CT), measured using ROTEM NATEM, between two blood samples collected from each participant. Sample 1 is collected immediately after catheter insertion, and Sample 2 is collected after a standardized flush and discard procedure. The change in CT will be compared across the four catheter groups to evaluate differences in coagulation activation.
Change in ROTEM NATEM CT between Sample 1 and Sample 2: within-group and overall cohort comparisons.
Change in ROTEM NATEM CT between Sample 1 and Sample 2: within-group and overall cohort comparisons.
Change in ROTEM NATEM Clot Formation Time (CFT) (seconds) between Sample 1 and Sample 2
Between-group comparison of the change in ROTEM NATEM Clot Formation Time (ΔCFT) (seconds) between Sample 1 and Sample 2, with within-group comparisons of CFT and an overall cohort comparison of Sample 1 versus Sample 2.
Change in ROTEM Alpha Angle (α-angle) (degrees) between Sample 1 and Sample 2
Between-group comparison of the change in ROTEM NATEM Alpha Angle (Δα-angle, degrees) between Sample 1 and Sample 2, with within-group comparisons of α-angle and an overall cohort comparison of Sample 1 versus Sample 2.
Change in ROTEM Maximum Clot Firmness (MCF) (mm) between Sample 1 and Sample 2
Between-group comparison of the change in ROTEM NATEM Maximum Clot Firmness (MCF) (mm) between Sample 1 and Sample 2, with within-group comparisons of MCF and an overall cohort comparison of Sample 1 versus Sample 2.
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