How newly inserted central venous catheters trigger blood clotting
Contact Activation of Coagulation in Newly Inserted Central Catheters - a Randomized Controlled Trial
This trial tests whether four different types of central venous catheters change blood clotting immediately after placement in adults who need a central line.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Lund, Skåne County) |
| Trial ID | NCT07014722 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls 88 adults who require a two‑lumen central venous catheter and randomizes them to one of four commercially available catheter types. Blood is drawn immediately after insertion and again after a standardized saline flush to measure clotting time and other parameters using rotational thromboelastometry (ROTEM NATEM) and routine coagulation tests. The catheters compared include two standard polyurethane models, one chlorhexidine/silver sulfadiazine–coated model, and one polyurethane shaft embedded with silver ions, all inserted without pre‑filling with saline. Patients on most anticoagulants or with known bleeding disorders are excluded to isolate catheter‑related effects on coagulation.
Who should consider this trial
Good fit: Adults (≥18) who need a two‑lumen central venous catheter of 150–160 mm length, can give informed consent, and do not meet the anticoagulant or coagulopathy exclusion criteria are appropriate candidates.
Not a fit: Patients on therapeutic anticoagulation, with known coagulopathies, very low platelets or severe anemia, children, or those needing different catheter lengths are unlikely to get direct benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians pick catheter types that cause less immediate clotting and thereby reduce catheter‑related thrombosis and complications.
How similar studies have performed: Prior work has examined how catheter materials and antimicrobial coatings affect thrombosis with mixed results, while directly comparing immediate ROTEM‑measured contact activation across multiple commercial catheters is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Participants must meet all of the following criteria to be included in the study: 1. Clinical indication for the placement of a two-lumen central venous catheter with length 150-160 mm. 2. Age ≥18 years. 3. Signed informed consent. Exclusion Criteria Participants meeting any of the following criteria will be excluded: 1. Current use of anticoagulants or platelet inhibitors, except: Prophylactic low molecular weight heparin (LMWH), double prophylactic dose of LMWH, Acetylsalicylic acid (ASA). 2. 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. 3. 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.
Where this trial is running
Lund, Skåne County
- Skåne University Hospital Lund — Lund, Skåne County, Sweden (Recruiting)
Study contacts
- Study coordinator: Thomas Kander, Professor
- Email: thomas.kander@med.lu.se
- Phone: +4646171163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.