Contact Activation of Coagulation in Newly Inserted Central Venous Catheters

NCT07014722 | Recruiting

• 1 other identifier: CAS-2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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 Complications; Central Venous Catheter; Coagulation; Coagulation Activation

Keywords

coagulation; ROTEM; central venous catheter

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)

Secondary Outcomes (9)

• Change in ROTEM NATEM CT between Sample 1 and Sample 2: within-group and overall cohort comparisons.

  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

  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

  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

  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

  Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (Sample 2)

Study Arms (4)

Group A: MERITMEDICAL Careflow™

ACTIVE COMPARATOR

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

Group B: ARROW

ACTIVE COMPARATOR

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

Group C: ARROWg+ard Blue Plus®

ACTIVE COMPARATOR

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

Group D: Multicath 2 Expert UP

ACTIVE COMPARATOR

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

Interventions

Multicath 2 Expert UP Two-Lumen Central Venous Catheter DEVICE

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

Group D: Multicath 2 Expert UP

MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter DEVICE

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

Group A: MERITMEDICAL Careflow™

ARROW Two-Lumen Central Venous Catheter DEVICE

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

Group B: ARROW

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

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

Group C: ARROWg+ard Blue Plus®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Kander: lead
• Lund University: collaborator

Study Sites (1)

Skåne University Hospital Lund

Lund, Skåne County, 22242, Sweden

RECRUITING

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Thomas Kander, Professor

CONTACT

+4646171163; thomas.kander@med.lu.se

Aida Zorlak, MD

CONTACT

+4646171088; aida.zorlak@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Assossors of routine and complementary coagulation assays are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 11, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available starting 6 months after publication of the primary results and will remain available for 5 years.
• Access Criteria: Access will be granted to researchers or organizations submitting a methodologically sound proposal. Approval is at the discretion of the study investigators, subject to compliance with applicable regulations and ethical considerations.

Locations

SE (1)