Contact Activation of Coagulation in Newly Inserted Central Catheters - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in ROTEM NATEM Clotting Time (CT) (seconds) between Sample 1 and Sample 2
研究概览
简要总结
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.
详细描述
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:
- MERITMEDICAL Careflow™ Two-Lumen Catheter (7 Fr, 150 mm, polyurethane, OD 2.4 mm)
- ARROW Two-Lumen Catheter (7 Fr, 160 mm, polyurethane, OD 2.5 mm)
- ARROWg+ard Blue Plus® Two-Lumen Catheter (8 Fr, 160 mm, polyurethane, OD 2.8 mm, chlorhexidine/silver sulfadiazine coating)
- Multicath 2 Expert UP Two-Lumen Catheter (7.5 Fr, 160 mm, polyurethane shaft embedded with silver ions, OD 2.5 mm)
Blood samples will be collected at two time points for each participant:
- Sample 1: Immediately after catheter insertion, before flushing
- Sample 2: After at least 10 ml saline flush and discard protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Assossors of routine and complementary coagulation assays are masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A: MERITMEDICAL Careflow™
Participants will receive a MERITMEDICAL Careflow™ two-lumen 7 Fr, 150 mm, polyurethane central venous catheter (OD 2.4 mm).
干预措施: MERITMEDICAL Careflow™ Two-Lumen Central Venous Catheter (Device)
Group B: ARROW
Participants will receive an ARROW two-lumen 7 Fr, 160 mm, polyurethane central venous catheter (OD 2.5 mm).
干预措施: ARROW Two-Lumen Central Venous Catheter (Device)
Group C: ARROWg+ard Blue Plus®
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.
干预措施: ARROWg+ard Blue Plus® Two-Lumen Central Venous Catheter (Device)
Group D: Multicath 2 Expert UP
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).
干预措施: Multicath 2 Expert UP Two-Lumen Central Venous Catheter (Device)
结局指标
主要结局
Change in ROTEM NATEM Clotting Time (CT) (seconds) between Sample 1 and Sample 2
时间窗: Immediately after catheter insertion (Sample 1) and after flush and discard, within one hour (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.
次要结局
- 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))
- Change in Activated Partial Thromboplastin Time (aPTT) (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 Factor VII Activity (FVII) (kIU/L) between Sample 1 and Sample 2(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(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(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 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))
研究者
Thomas Kander
Professor
Region Skane