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Contact Activation of Coagulation in Newly Inserted Central Venous Catheters

Study acronym: CAS-2
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 7 more changesShow less
    • Primary completion date changed from estimate of Dec 30, 2026 to May 15, 2026
    • Study completion date changed from estimate of Dec 30, 2026 to Aug 15, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Study description expanded, about 6 words
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Primary endpoint revised
    • Secondary endpoints revised (9)
    • Eligibility criteria shortened, about 5 words
    • Collaborators expanded, about 2 words
    v5
  3. Primary completion date: Dec 30, 2025 to Dec 30, 2026
    • Study completion date: Nov 30, 2026 to Dec 30, 2026
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Enrollment target: 80 to 88
    • Start date changed from estimate of Sep 1, 2025 to Sep 10, 2025
    • Eligibility criteria revised
    • Site details revised
    • Study description expanded, about 3 words
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07014722
Lead Sponsor Thomas Kander
Collaborators: Lund University
Conditions
(from sponsor)		 Central Venous Catheter, Coagulation, Coagulation Activation, Central Venous Catheter Complications
Related terms Thrombosis
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov