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Completed

NCT Number: NCT01943006

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chulalongkorn Hospital, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hirudoid cream 0.3 % Mucopolysaccharide polysulfate

Drug

Hirudoid cream

Placebo cream without active substance

Drug

Primary outcomes

  1. Number of patient developing superficial thrombophlebitis

    Time frame: 7 days

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medinova AG

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2013
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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