Heparin 100U/L for Prevention of PVC Complications

Phase 3

Completed

• Conditions: Peripheral Venous Catheter Complications; Occlusion; Ecchymosis; Phlebitis
• Interventions: Other: heparin 100U/L flushes

• Registration Number: NCT01131754
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-02
• Study Start: 2007-06
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Last Update Submitted: 2010-06-13
• Last Update Posted: 2010-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin sol 100U/L	heparin 100U/L flushes	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.
saline	heparin 100U/L flushes	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medicina 3 - IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy