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

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ClinicalTrials.gov Identifier: NCT01943006
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Medinova AG

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.


Condition or disease Intervention/treatment Phase
Thrombophlebitis Phlebitis Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate Drug: Placebo cream without active substance Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment of Superficial Infusion Thrombophlebitis
Study Start Date : May 2015
Primary Completion Date : February 2017
Study Completion Date : March 2017

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



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

Secondary Outcome Measures :
  1. Time to develop infusion related superficial thrombophlebitis [ Time Frame: 7 days ]
  2. Change of clinical symptoms in patients who developed superficial thrombophlebitis [ Time Frame: 14 days ]
    Pain score (10-point visual analogue score) Extent of erythema

  3. Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis [ Time Frame: 14 days ]
  4. Investigators' satisfaction [ Time Frame: 14 days ]
    4-point rating scale

  5. Patient' satisfaction [ Time Frame: 14 days ]
    4-point rating scale

  6. 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

  7. 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:
  1. Fasting blood glucose (FBS) [ Time Frame: 14 days ]
    Laboratory test performed on day 1 and at the end of the study

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

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

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

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

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

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



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943006


Locations
Thailand
Siriraj Hospital
Bangkok, Thailand, 107000
Chulalongkorn Hospital
Bangkok, Thailand
Rajvithi Hospital
Bangkok, Thailand
Bamrasnaradua Infectious Diseases Institute
Nonthaburi, Thailand
Sponsors and Collaborators
Medinova AG

Responsible Party: Medinova AG
ClinicalTrials.gov Identifier: NCT01943006     History of Changes
Other Study ID Numbers: Hir-901113
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by Medinova AG:
Mucopolysaccaride polysulfate (MPS)
MPS
Heparinoide
Infusionphlebitis
Prevention
Superficial thrombophlebitis
Treatment

Additional relevant MeSH terms:
Thrombophlebitis
Phlebitis
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Vasculitis
Heparinoids
Anti-Inflammatory Agents
Anticoagulants