Clinical trial NCT01943006: Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment Infusion Phlebitis
Official title: Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment of Superficial Infusion Thrombophlebitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombophlebitis
Phlebitis
Keywords: Mucopolysaccaride polysulfate (MPS)
MPS
Heparinoide
Infusionphlebitis
Prevention
Superficial thrombophlebitis
Treatment
Lead sponsor: Medinova AG
Sponsor class: INDUSTRY
First posted: 2013-09-16
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of patient developing superficial thrombophlebitis
timeFrame: 7 days
Secondary outcomes:
measure: Time to develop infusion related superficial thrombophlebitis
timeFrame: 7 days
measure: Change of clinical symptoms in patients who developed superficial thrombophlebitis
timeFrame: 14 days
measure: Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis
timeFrame: 14 days
measure: Investigators' satisfaction
timeFrame: 14 days
measure: Patient' satisfaction
timeFrame: 14 days
measure: Number of adverse events
timeFrame: 14 days
measure: Global tolerability
timeFrame: 14 days
Other outcomes:
measure: Fasting blood glucose (FBS)
timeFrame: 14 days
measure: Platelet, red blood cell and leukocyte count
timeFrame: 14 days
measure: Alanine transaminase (ALT),
timeFrame: 14 days
measure: Aspartate transaminase (AST),
timeFrame: 14 days
measure: Fibrinogen and activated partial thromboplastin time (aPTT)
timeFrame: 14 days
measure: Prothrombin time (PT)
timeFrame: 14 days
measure: Serum creatinine
timeFrame: 14 days
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Rajvithi Hospital
city: Nonthaburi
country: Thailand
facility: Bamrasnaradua Infectious Diseases Institute
Study officials:
References: