NCT05209841 Heparinization vs Salinization of the Peripheral Venous Catheter
| NCT ID | NCT05209841 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf |
| Condition | Catheter Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,450 participants |
| Start Date | 2022-04-05 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,450 participants in total. It began in 2022-04-05 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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, which has not been channeled in a medical emergency situation. * Written informed consent 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 affect the patency of venous catheters.
Contact & Investigator
Esther Moreno Rubio
PRINCIPAL INVESTIGATOR
CSAPG
Frequently Asked Questions
Who can join the NCT05209841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Catheter Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05209841 currently recruiting?
Yes, NCT05209841 is actively recruiting participants. Contact the research team at emoreno@csapg.cat for enrollment information.
Where is the NCT05209841 trial being conducted?
This trial is being conducted at Sant Pere de Ribes, Spain.
Who is sponsoring the NCT05209841 clinical trial?
NCT05209841 is sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. The principal investigator is Esther Moreno Rubio at CSAPG. The trial plans to enroll 3,450 participants.