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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thrombophlebitis, Phlebitis

Intervention / Treatment
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* Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate
* Drug: Placebo cream without active substance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hirudoid cream<br>Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily | Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate<br>* Hirudoid cream<br>|
| Placebo Comparator: Placebo<br>Patients treated with placebo cream without active substance Twice daily | Drug: Placebo cream without active substance<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MPS, Mucopolysaccaride polysulfate (MPS), Heparinoide, Infusionphlebitis, Prevention, Superficial thrombophlebitis, Treatment