Heparinization vs Salinization of the Peripheral Venous Catheter: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,450
- 试验地点
- 1
- 主要终点
- Percentage of obstructed catheters
研究概览
简要总结
Randomized, double-blind clinical trial to compare the efficacy of catheter sealing with saline, compared to low-dose heparin. 3,450 patients hospitalized at the Hospital Residencia Sant Camil, in Catalonia (Spain), will be randomized to each branch of study. The primary outcome will be the percentage of catheters removed due to obstruction in each branch of study. As secondary outcomes, the number of catheter-associated phlebitis, catheter-associated bacetrihemia, extravasation, and catheter loss will be measured. For the primary outcome, a superiority analysis will be carried out in terms of the percentage of obstructed catheters in each branch of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 yo, admitted to the Hospital Residencia Sant Camil
- •Patients with at least one peripheral venous line for discontinuous treatment, which has not been channeled in a medical emergency situation.
- •Written informed consent
排除标准
- •Allergy to heparin
- •Patients treated with unfractionated sodium heparin.
- •Patients in dialysis
- •Patients with a venous catheter indicated for diagnosis tests.
- •Patients with a venous catheter indicated for blood transfusion
- •Severe heparin-induced thrombocytopenia in recent months
- •Active uncontrollable bleeding during admission
- •Brain aneurysm or dissecting aorta, except in association with corrective surgery.
- •Confirmed / suspected cerebrovascular hemorrhage
- •Severe uncontrolled hypertension
- •Severe alterations in platelet coagulation <30,000, TP> 1.7 APTT ratio> 1.7 ratio.
- •Patient included in another clinical trial with drugs or procedures that may affect the patency of venous catheters.
研究组 & 干预措施
Catheter sealing with low dose heparin
Catheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL)
干预措施: Low dose heparin (Drug)
Catheter sealing with normal saline
Catheters will be sealed with 3mL of 0.9% sodium chloride
干预措施: Normal saline (Drug)
结局指标
主要结局
Percentage of obstructed catheters
时间窗: From date of randomization through the date of hospital discharge, an average of 10 days.
percentage of obstructed catheters
次要结局
- Number of catheter-associated bacterihemia episodes(From date of randomization through the date of hospital discharge, an average of 10 days.)
- Number of catheter loss due to extravasation(From date of randomization through the date of hospital discharge, an average of 10 days.)
- Number of catheter-associated phlebitis(From date of randomization through the date of hospital discharge, an average of 10 days.)