Heparin 100U/L for Prevention of PVC Complications

Fondazione IRCCS Policlinico San Matteo di Pavia214 enrolled

Overview

Flushes with saline solution are used for maintaining patency of peripheral intermittent intravenous catheters in many institution based on the results of previous studies showing that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an intermittent flush, but no firm conclusion was reached because of limitations of the few available studies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

214

Conditions

Peripheral Venous Catheter Complications Occlusion Phlebitis Ecchymosis

Interventions

heparin 100U/L flushesOTHER

peripheral venous catheter flushing with 3 mL of a 100 U heparin/mL normal saline from mono-use vial (Epsodilave, Mayne Pharma, Naples, Italy) at the end of each drug infusion. Independently from the number of drug infusions, all patients will receive at least two catheter flushes every day.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * requiring i.v. therapy for an expected duration longer than five days * admitted to the 3rd medical ward of IRCCS Policlinico San Matteo Exclusion Criteria: * bleeding tendency * platelet count less than 100 x 109/L * coagulation defects * previous adverse reaction to heparin * programmed cytotoxic therapy * inability to give an informed consent

Outcomes

Primary Outcomes

Phlebitis or Occlusion

Phlebitis is defined as the presence of two or more symptoms/signs among pain, tenderness, warmth, erythema, swelling, or a palpable cord (score of ≥ 2 according to the Visual Infusion Phlebitis Score). Occlusion is defined as resistance to flushing as evidenced by the inability to administer 1 ml of flushing solution within 30 seconds.

Secondary Outcomes

Ecchymosis

Ecchymosis is defined as a purple discoloration of the skin around the catheter insertion site larger than 1 cm.

Heparin induced thrombocytopenia

Heparin induced thrombocytopenia is defined as a fall in platelet count \> 50% of baseline value without any alternative explanation. To detect this phenomenon, platelet count is to be performed at baseline and, subsequently, every 5 days.