Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment Infusion Phlebitis

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

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.

Study Overview

• Status: Completed
• Conditions: Phlebitis; Thrombophlebitis
• Intervention / Treatment: Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate; Drug: Placebo cream without active substance

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 107000
    • Siriraj Hospital
  • Bangkok, Thailand
    • Chulalongkorn Hospital
  • Bangkok, Thailand
    • Rajvithi Hospital
  • Nonthaburi, Thailand
    • Bamrasnaradua Infectious Diseases Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are admitted to the hospital requiring to receive infusion of a complete nutritional emulsion for 3 days (Kabiven® Peripheral, 1400 kcal, 1920 ml, 750 mosmol/L, pH 5.6),
• Aged 18-65 years.
• Patients who are able to understand the requirements of the study and agree to sign an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the study.

Exclusion Criteria:

• Patients known to be allergic to Hirudoid or any ingredients of Hirudoid
• Patients with impaired skin integrity caused by lesion or soft tissue trauma
• Patients having skin lesions with ulcerations or any other severe dermatologic disease
• Patients has been received a complete nutritional emulsion infusion within 7 days of inclusion
• Patients with severe uncontrolled medical conditions, which makes it undesirable or unsafe for the patients to participate in the study, such as: Acute or chronic uncontrolled severe infections,Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, serious uncontrolled cardiac arrhythmia or any other clinically serious cardiac disease, Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN; optimal glycaemic control should be achieved before starting trial therapy, Uncontrolled bleeding
• Patients known to have coagulation disorders such as Haemophilia, Thrombocytopenia, Thrombosis, Other severe hematologic conditions like leukaemia, especially with abnormal coagulation
• Patients who have symptoms of microangiopathy (small vessel disease) or neuropathy related to diabetes and other diseases
• Patients with hyperthyroidism and hypothyroidism
• Patients who are pregnant or breast feeding
• Patients who are on anticoagulant therapy (last 2 weeks)
• Patients with severe psychiatric conditions
• Patients who are unable to bear legal responsibility or unable to understand the study
• Patients who are unreliable or unable to comply with the protocol, like alcohol or drug abusers
• Patients who had been participated in another clinical trial in the past 12 weeks
• Patient is relatives of, or staff directly reporting to, the investigator
• Patient is employee of the sponsor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hirudoid cream; Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily	Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate; Hirudoid cream
Placebo Comparator: Placebo; Patients treated with placebo cream without active substance Twice daily	Drug: Placebo cream without active substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patient developing superficial thrombophlebitis	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to develop infusion related superficial thrombophlebitis		7 days
Change of clinical symptoms in patients who developed superficial thrombophlebitis	Pain score (10-point visual analogue score) Extent of erythema	14 days
Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis		14 days
Investigators' satisfaction	4-point rating scale	14 days
Patient' satisfaction	4-point rating scale	14 days
Number of adverse events	Number of any adverse events and adverse drug reactions including their severity experienced by the patients during the course of therapy	14 days
Global tolerability	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	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood glucose (FBS)	Laboratory test performed on day 1 and at the end of the study	14 days
Platelet, red blood cell and leukocyte count	Laboratory testing is performed on day 1 and end of study	14 days
Alanine transaminase (ALT),	Laboratory testing is performed on day 1 and end of study	14 days
Aspartate transaminase (AST),	Laboratory testing is performed on day 1 and end of study	14 days
Fibrinogen and activated partial thromboplastin time (aPTT)	Laboratory testing is performed on day 1 and end of study	14 days
Prothrombin time (PT)	Laboratory testing is performed on day 1 and end of study	14 days
Serum creatinine	Laboratory testing is performed on day 1 and end of study	14 days

Collaborators and Investigators

• Sponsor: Medinova AG

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (Estimate): September 16, 2013

Study Record Updates

• Last Update Posted (Actual): December 14, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Treatment; MPS; Prevention; Mucopolysaccaride polysulfate (MPS); Heparinoide; Infusionphlebitis; Superficial thrombophlebitis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Vasculitis; Venous Thrombosis; Thrombosis; Peripheral Vascular Diseases; Phlebitis; Thrombophlebitis
• Other Study ID Numbers: Hir-901113