Heparin 100U/L for Prevention of PVC Complications

Occlusion Clinical Trial

Official title:

STUDIO CLINICO RANDOMIZZATO SULL'UTILIZZO DI EPARINA PER LA PROFILASSI DELLA TROMBOFLEBITE DA CATETERE VENOSO PERIFERICO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131754
• Other study ID #: EPA 2007
• Secondary ID: 2007-001347-21
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2010
• Last updated: June 13, 2010
• Start date: June 2007
• Est. completion date: September 2009

Study information

• Verified date: February 2007
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ecchymosis
• Occlusion
• Peripheral Venous Catheter Complications
• Phlebitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	Medicina 3 - IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Yes
Secondary	Ecchymosis	Ecchymosis is defined as a purple discoloration of the skin around the catheter insertion site larger than 1 cm.		Yes
Secondary	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.		Yes