Actively Recruiting
Contact Activation of Coagulation in Newly Inserted Central Catheters - a Randomized Controlled Trial
Led by Thomas Kander · Updated on 2026-02-18
88
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Thomas Kander
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how four different types of central venous catheters (CVCs) affect the body's blood clotting system. CVCs are thin tubes placed in large veins to give medications, fluids, or take secure blood samples, but they can sometimes cause blood clots, leading to serious health issues. This randomized controlled trial aims to compare the impact on coagulation caused by these commonly used catheters to better understand clot formation after catheter insertion. Participants will be randomly assigned to receive one of four different two-lumen central venous catheters, each made of polyurethane but with different sizes or coatings, including antimicrobial and silver ion-embedded options. Blood samples will be taken twice from each catheter: once immediately after insertion without flushing, and once after flushing with saline and discarding the initial blood. These samples will then be tested with rotational thromboelastometry (ROTEM) and other coagulation tests to compare clotting times and related markers between catheter types and within the overall group. During the study, participants will undergo catheter placement followed by blood sample collection at two specific times. The blood will be processed and analyzed shortly after collection to measure clotting times, clot strength, and various coagulation factors. The main outcome is the change in clotting time between the two samples. This information will help researchers identify how different catheters interact with blood clotting and could lead to safer catheter use and better prevention of clot-related complications. Participants will be monitored throughout the procedure and sample collection process, which is expected to last a short time after catheter insertion.
CONDITIONS
Brief Title
Contact Activation of Coagulation in Newly Inserted Central Venous Catheters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical need for insertion of a two-lumen central venous catheter with length 150-160 mm
- Age 18 years or older
- Signed informed consent
You will not qualify if you...
- Current use of anticoagulants or platelet inhibitors, except prophylactic low molecular weight heparin or acetylsalicylic acid
- Abnormal prothrombin time (pK/INR outside 0.9-1.2), platelet count below 50 x 10⁹/L, or hemoglobin below 80 g/L if known
- Known coagulopathic conditions such as activated protein C resistance, hemophilia A or B, vitamin K deficiency, disseminated intravascular coagulation, antiphospholipid syndrome, von Willebrand disease, or other bleeding disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants receive insertion of one of four types of central venous catheters as assigned by randomization. Blood samples are collected immediately after catheter insertion and after flushing the catheter.
1 catheter insertion visit with 2 blood sample collections
Duration - Within 1 hour after catheter insertion
Participants have coagulation parameters measured from collected blood samples to evaluate clotting times and other blood coagulation markers.
Blood samples processed and analyzed within 3 hours of collection; no additional participant visits required
Trial Site Locations
Total: 1 location
1
Skåne University Hospital Lund
Lund, Skåne County, Sweden, 22242
Actively Recruiting
Research Team
T
Thomas Kander, Professor
A
Aida Zorlak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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