Heparin 100U/L for Prevention of PVC Complications

IRCCS Policlinico S. Matteo

Status and phase: Completed; Phase 3

Conditions: Ecchymosis; Occlusion; Phlebitis; Peripheral Venous Catheter Complications

Treatments: Other: heparin 100U/L flushes

Study type: Interventional

Funder types: Other

Identifiers

NCT01131754

EPA 2007

2007-001347-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Heparin sol 100U/L

Experimental group

Description:

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.

Treatment:

Other: heparin 100U/L flushes

saline

Active Comparator group

Description:

peripheral venous catheter flushing with 3 mL of normal saline from mono-use vials (prepared by the hospital pharmacy) at the end of each drug infusion. Independently of the number of drug infusions, all patients will receive at least two catheter flushes every day.

Treatment:

Other: heparin 100U/L flushes