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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Medinova AG
Information provided by (Responsible Party):
Medinova AG Identifier:
First received: September 6, 2013
Last updated: September 14, 2016
Last verified: September 2016

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.

Condition Intervention Phase
Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate
Drug: Placebo cream without active substance
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment of Superficial Infusion Thrombophlebitis

Further study details as provided by Medinova AG:

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

Secondary Outcome Measures:
  • 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

Other Outcome Measures:
  • Fasting blood glucose (FBS) [ Time Frame: 14 days ]
    Laboratory test performed on day 1 and at the end of the study

  • Platelet, red blood cell and leukocyte count [ Time Frame: 14 days ]
    Laboratory testing is performed on day 1 and end of study

  • Alanine transaminase (ALT), [ Time Frame: 14 days ]
    Laboratory testing is performed on day 1 and end of study

  • Aspartate transaminase (AST), [ Time Frame: 14 days ]
    Laboratory testing is performed on day 1 and end of study

  • Fibrinogen and activated partial thromboplastin time (aPTT) [ Time Frame: 14 days ]
    Laboratory testing is performed on day 1 and end of study

  • Prothrombin time (PT) [ Time Frame: 14 days ]
    Laboratory testing is performed on day 1 and end of study

  • Serum creatinine [ Time Frame: 14 days ]
    Laboratory testing is performed on day 1 and end of study

Estimated Enrollment: 144
Study Start Date: May 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01943006

Contact: Tun Myint Win, MD +66 8 1847 5696
Contact: Philipp Grob, PhD +41792910960

Siriraj Hospital Recruiting
Bangkok, Thailand, 107000
Contact: Varut Loshiriwat, MD    +66 892 165 298      
Principal Investigator: Varut Lohsiriwat, MD         
Chulalongkorn Hospital Recruiting
Bangkok, Thailand
Contact: Boonchoo Sirichindakul, MD    +66 2 256 4117      
Principal Investigator: Boonchoo Sirichindakul, MD         
Rajvithi Hospital Recruiting
Bangkok, Thailand
Contact: Santi Lokecharoenlarb, MD    +66 89 119 9190      
Principal Investigator: Santi Lokecharoenlarb, MD         
Bamrasnaradua Infectious Diseases Institute Recruiting
Nonthaburi, Thailand
Contact: Suthat Chottanapund, MD         
Sponsors and Collaborators
Medinova AG
  More Information

Responsible Party: Medinova AG Identifier: NCT01943006     History of Changes
Other Study ID Numbers: Hir-901113
Study First Received: September 6, 2013
Last Updated: September 14, 2016

Keywords provided by Medinova AG:
Mucopolysaccaride polysulfate (MPS)
Superficial thrombophlebitis

Additional relevant MeSH terms:
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Thrombosis
Embolism and Thrombosis
Anti-Inflammatory Agents
Anticoagulants processed this record on May 25, 2017