Heparinization vs Salinization of the Peripheral Venous Catheter

Официальное название

Heparinization vs Salinization of the Peripheral Venous Catheter: a Randomized Clinical Trial

Обзор

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.

Вмешательства

• Препарат Low dose heparin
  Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)
• Препарат Normal saline
  Catheters will be sealed with 3mL of 0.9% sodium chloride

Первичные конечные точки

• Percentage of obstructed catheters [Срок оценки: From date of randomization through the date of hospital discharge, an average of 10 days.]

Вторичные конечные точки (3)

• Number of catheter-associated phlebitis [Срок оценки: From date of randomization through the date of hospital discharge, an average of 10 days.]
• Number of catheter-associated bacterihemia episodes [Срок оценки: From date of randomization through the date of hospital discharge, an average of 10 days.]
• Number of catheter loss due to extravasation [Срок оценки: From date of randomization through the date of hospital discharge, an average of 10 days.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Hospital Residència Sant Camil — Sant Pere de Ribes

Идентификаторы

NCT: NCT05209841 · CSAPG-18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗