Heparinization vs Salinization of the Peripheral Venous Catheter
1 other identifier
interventional
3,450
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedStudy Start
First participant enrolled
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
June 25, 2025
June 1, 2025
4.3 years
December 29, 2021
June 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of obstructed catheters
percentage of obstructed catheters
From date of randomization through the date of hospital discharge, an average of 10 days.
Secondary Outcomes (3)
Number of catheter-associated phlebitis
From date of randomization through the date of hospital discharge, an average of 10 days.
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.
Study Arms (2)
Catheter sealing with low dose heparin
EXPERIMENTALCatheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL)
Catheter sealing with normal saline
ACTIVE COMPARATORCatheters will be sealed with 3mL of 0.9% sodium chloride
Interventions
Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)
Catheters will be sealed with 3mL of 0.9% sodium chloride
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Residència Sant Camil
Sant Pere de Ribes, Barcelona, 08810, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esther Moreno Rubio
CSAPG
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2021
First Posted
January 27, 2022
Study Start
April 5, 2022
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- After publication of main results of the study
- Access Criteria
- IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).