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

NCT ID: NCT01943006

Last Updated: 2017-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-03-31

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.

Conditions

Thrombophlebitis; Phlebitis

Keywords

Mucopolysaccaride polysulfate (MPS); MPS; Heparinoide; Infusionphlebitis; Prevention; Superficial thrombophlebitis; Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Hirudoid cream

Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate

Twice daily

Group Type: EXPERIMENTAL

Hirudoid cream 0.3 % Mucopolysaccharide polysulfate

Intervention Type: DRUG

Hirudoid cream

Placebo

Patients treated with placebo cream without active substance

Twice daily

Group Type: PLACEBO_COMPARATOR

Placebo cream without active substance

Intervention Type: DRUG

Interventions

Hirudoid cream 0.3 % Mucopolysaccharide polysulfate

Hirudoid cream

Intervention Type: DRUG

Placebo cream without active substance

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medinova AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Siriraj Hospital

Bangkok, , Thailand

Chulalongkorn Hospital

Bangkok, , Thailand

Rajvithi Hospital

Bangkok, , Thailand

Bamrasnaradua Infectious Diseases Institute

Nonthaburi, , Thailand

Countries

Thailand

Other Identifiers

Hir-901113

Identifier Type: -

Identifier Source: org_study_id