Clinical Trial: Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment Infusion Phlebitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment of Superficial Infusion Thrombophlebitis

Brief Summary:

Patients receiving nutritional emulsion for at least 3 days will be treated with Hirudoid cream or placebo cream to prevent and treat phlebitis caused by the infusion. The treatment is continued after the end of infusion for at least 7 days.

Number of patients developing superficial phlebitis and duration of phlebitis will be recorded.


Detailed Summary:
Sponsor: Medinova AG

Current Primary Outcome: Number of patient developing superficial thrombophlebitis [ Time Frame: 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to develop infusion related superficial thrombophlebitis [ Time Frame: 7 days ]
  • Change of clinical symptoms in patients who developed superficial thrombophlebitis [ Time Frame: 14 days ]
    Pain score (10-point visual analogue score) Extent of erythema
  • Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis [ Time Frame: 14 days ]
  • Investigators' satisfaction [ Time Frame: 14 days ]
    4-point rating scale
  • Patient' satisfaction [ Time Frame: 14 days ]
    4-point rating scale
  • Number of adverse events [ Time Frame: 14 days ]
    Number of any adverse events and adverse drug reactions including their severity experienced by the patients during the course of therapy
  • Global tolerability [ Time Frame: 14 days ]
    Rating of tolerance by investigator and patients using targeted questionnaire 4-point scale (very good, good, moderate, no change or deterioration) at the end of the study


Original Secondary Outcome: Same as current

Information By: Medinova AG

Dates:
Date Received: September 6, 2013
Date Started: May 2015
Date Completion: March 2017
Last Updated: September 14, 2016
Last Verified: September 2016