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

Phase 3

Completed

• Conditions: Thrombophlebitis; Phlebitis
• Interventions: Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate; Drug: Placebo cream without active substance

• Registration Number: NCT01943006
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Study Start: 2015-05
• Primary Completion: 2017-02
• Study Completion: 2017-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hirudoid cream	Hirudoid cream 0.3 % Mucopolysaccharide polysulfate	Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily
Placebo	Placebo cream without active substance	Patients treated with placebo cream without active substance Twice daily

Primary Outcome Measures

Name	Time	Method
Number of patient developing superficial thrombophlebitis	7 days

Secondary Outcome Measures

Name	Time	Method
Time to develop infusion related superficial thrombophlebitis	7 days
Investigators' satisfaction	14 days	4-point rating scale
Change of clinical symptoms in patients who developed superficial thrombophlebitis	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	14 days
Patient' satisfaction	14 days	4-point rating scale
Number of adverse events	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	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

Trial Locations

Locations (4)

Rajvithi Hospital; 🇹🇭 Bangkok, Thailand

Bamrasnaradua Infectious Diseases Institute; 🇹🇭 Nonthaburi, Thailand

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand

Siriraj Hospital; 🇹🇭 Bangkok, Thailand