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

Medinova

Status and phase

Completed

Phase 3

Conditions

Thrombophlebitis

Phlebitis

Treatments

Drug: Placebo cream without active substance

Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01943006

Hir-901113

Details and patient eligibility

About

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.

Enrollment

144 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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