An interventional study of MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter and ARROW Two-Lumen Central Venous Catheter in Central Venous Catheter, Coagulation and Coagulation Activation, sponsored by Thomas Kander. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Thomas Kander · Not applicable, Interventional, and Treatment
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.
This is a randomized controlled trial, designed to evaluate coagulation activation in response to four different commercially available central venous catheters (CVCs), all with similar internal surface areas. The study focuses on comparing changes in coagulation parameters, primarily clotting time (CT), measured using rotational thromboelastometry (ROTEM® NATEM), as well as additional ROTEM variables and standard coagulation markers.
Participants are included based on clinical need for central venous access, and are randomized using REDCap to receive one of four CVC types:
Blood samples will be collected at two time points for each participant:
All catheters will be inserted without pre-procedural filling with saline.
Blood will be collected into Vacuette® CTAD tubes (Greiner Bio-One, Kremsmünster, Austria) containing sodium citrate, theophylline, adenosine, and dipyridamole, designed for hemostatic testing. The tubes will be inverted eight times immediately after blood collection and kept at 37°C until processing. ROTEM® analysis will be performed within 3 hours of blood collection. After the ROTEM® analysis, the remaining blood will undergo centrifugation at 4000g for 15 minutes, and 600-700 µL of plasma from each sample will be transferred into cryotubes, which will be immediately frozen and stored at -80°C for further analysis.
Laboratory and ROTEM® Analyses
ROTEM® analyses will be performed on whole blood using recalcified non-activated thromboelastometry (NATEM), in accordance with the manufacturer's instructions. Each test will be run for 60 minutes, measuring the following variables:
Clotting Time (CT) - time to initial fibrin formation Clot Formation Time (CFT) - speed of thrombus development Alpha Angle (α-angle) - kinetics of clot formation Maximum Clot Firmness (MCF) - measure of final clot strength
Routine Plasma-Based Coagulation Assays:
Prothrombin Time-International Normalized Ratio (PT-INR) Activated Partial Thromboplastin Time (aPTT)
The following coagulation markers will also be assessed:
Factor VII (FVII) and Factor XII (FXII) Thrombin-Antithrombin Complex (TAT)
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 88 is below the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Thomas Kander is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Participants must meet all of the following criteria to be included in the study:
Exclusion Criteria
Participants meeting any of the following criteria will be excluded:
Known coagulopathic conditions, including but not limited to:
Participants will receive a MERITMEDICAL Careflow™ two-lumen 7 Fr, 150 mm, polyurethane central venous catheter (OD 2.4 mm).
Device: MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter
Participants will receive an ARROW two-lumen 7 Fr, 160 mm, polyurethane central venous catheter (OD 2.5 mm).
Device: ARROW Two-Lumen Central Venous Catheter
Participants will receive an ARROWg+ard Blue Plus® two-lumen 8 Fr, 160 mm, polyurethane catheter (OD 2.8 mm) with chlorhexidine and silver sulfadiazine coating.
Device: ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter
Participants will receive a Multicath 2 Expert UP two-lumen 7.5 Fr, 160 mm, polyurethane shaft embedded with silver ions (OD 2.5 mm).
Device: Multicath 2 Expert UP Two-Lumen Central Venous Catheter
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.
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.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
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.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
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.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (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.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (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.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Prothrombin Time - International Normalized Ratio (PT-INR) (continous unitless variable) between Sample 1 and Sample 2
Between-group comparison of the change in Prothrombin Time - International Normalized Ratio (PT-INR) between Sample 1 and Sample 2, with within-group comparisons of PT-INR and an overall cohort comparison of Sample 1 versus Sample 2.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Activated Partial Thromboplastin Time (aPTT) (seconds) between Sample 1 and Sample 2
Between-group comparison of the change in Activated Partial Thromboplastin Time (aPTT) (seconds) between Sample 1 and Sample 2, with within-group comparisons of aPTT and an overall cohort comparison of Sample 1 versus Sample 2.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Factor VII Activity (FVII) (kIU/L) between Sample 1 and Sample 2
Between-group comparison of the change in Factor VII Activity (FVII) (kIU/L) between Sample 1 and Sample 2, with within-group comparisons of FVII and an overall cohort comparison of Sample 1 versus Sample 2.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Factor XII Activity (FXII) (kIU/L) between Sample 1 and Sample 2
Between-group comparison of the change in Factor XII Activity (FXII) (kIU/L) between Sample 1 and Sample 2, with within-group comparisons of FXII and an overall cohort comparison of Sample 1 versus Sample 2.
Time frame: Time Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Change in Thrombin-Antithrombin Complex Concentration (TAT) (mikrogr/L) between Sample 1 and Sample 2
Between-group comparison of the change in Thrombin-Antithrombin Complex Concentration (TAT) (mikrogr/L) between Sample 1 and Sample 2, with within-group comparisons of TAT and an overall cohort comparison of Sample 1 versus Sample 2.
Time frame: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the study results will be made available upon reasonable request. Data will be completely anonymized prior to sharing, in accordance with applicable data protection regulations. Requests from both academic researchers and commercial entities (e.g., device manufacturers) will be considered. All requests will undergo review to assess scientific validity and compliance with ethical standards.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Thomas Kander