Heparinization vs Salinization of the Peripheral Venous Catheter

Study Overview
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Brief Summary
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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.

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

Conditions
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Catheter Complications

Intervention / Treatment
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* Drug: Low dose heparin
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter sealing with low dose heparin<br>Catheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL) | Drug: Low dose heparin<br>* Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)<br>|
| Active Comparator: Catheter sealing with normal saline<br>Catheters will be sealed with 3mL of 0.9% sodium chloride | Drug: Normal saline<br>* Catheters will be sealed with 3mL of 0.9% sodium chloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of obstructed catheters | percentage of obstructed catheters | From date of randomization through the date of hospital discharge, an average of 10 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of catheter-associated phlebitis | 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 | 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 | Number of catheter loss due to extravasation | From date of randomization through the date of hospital discharge, an average of 10 days. |