Clinical Trial: Heparin 100U/L for Prevention of PVC Complications

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: IRCCS Policlinico S. Matteo

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: IRCCS Policlinico S. Matteo

Dates:
Date Received: May 26, 2010
Date Started: June 2007
Date Completion:
Last Updated: June 13, 2010
Last Verified: February 2007