Heparinization vs Salinization of the Peripheral Venous Catheter

Last updated: March 19, 2024
Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Overall Status: Active - Recruiting

Phase

N/A

Condition

Catheter Complications

Treatment

Low dose heparin

Normal saline

Clinical Study ID

NCT05209841
CSAPG-18
  • Ages 18-100
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients older than 18 yo, admitted to the Hospital Residencia Sant Camil
  • Patients with at least one peripheral venous line for discontinuous treatment, whichhas not been channeled in a medical emergency situation.
  • Written informed consent

Exclusion

Exclusion Criteria:

  • 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 affectthe patency of venous catheters.

Study Design

Total Participants: 3450
Treatment Group(s): 2
Primary Treatment: Low dose heparin
Phase:
Study Start date:
April 05, 2022
Estimated Completion Date:
July 30, 2025

Connect with a study center

  • Hospital Residència Sant Camil

    Sant Pere De Ribes, Barcelona 08810
    Spain

    Active - Recruiting

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