RecruitingNot ApplicableNCT05209841

Heparinization vs Salinization of the Peripheral Venous Catheter

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


Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Enrollment

3,450 participants

Start Date

Apr 5, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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

Exclusion Criteria12

  • 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.

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Interventions

DRUGLow dose heparin

Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)

DRUGNormal saline

Catheters will be sealed with 3mL of 0.9% sodium chloride


Locations(1)

Hospital Residència Sant Camil

Sant Pere de Ribes, Barcelona, Spain

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NCT05209841


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