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

Phlebitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943006
• Other study ID #: Hir-901113
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2013
• Last updated: December 12, 2017
• Start date: May 2015
• Est. completion date: March 2017

Study information

• Verified date: December 2017
• Source: Medinova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Phlebitis
• Thrombophlebitis

Intervention

Drug:
• Hirudoid cream 0.3 % Mucopolysaccharide polysulfate
Hirudoid cream
• Placebo cream without active substance

Locations

Country	Name	City	State
Thailand	Chulalongkorn Hospital	Bangkok
Thailand	Rajvithi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Bamrasnaradua Infectious Diseases Institute	Nonthaburi

Sponsors (1)

Lead Sponsor	Collaborator
Medinova AG

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting blood glucose (FBS)	Laboratory test performed on day 1 and at the end of the study	14 days
Other	Platelet, red blood cell and leukocyte count	Laboratory testing is performed on day 1 and end of study	14 days
Other	Alanine transaminase (ALT),	Laboratory testing is performed on day 1 and end of study	14 days
Other	Aspartate transaminase (AST),	Laboratory testing is performed on day 1 and end of study	14 days
Other	Fibrinogen and activated partial thromboplastin time (aPTT)	Laboratory testing is performed on day 1 and end of study	14 days
Other	Prothrombin time (PT)	Laboratory testing is performed on day 1 and end of study	14 days
Other	Serum creatinine	Laboratory testing is performed on day 1 and end of study	14 days
Primary	Number of patient developing superficial thrombophlebitis		7 days
Secondary	Time to develop infusion related superficial thrombophlebitis		7 days
Secondary	Change of clinical symptoms in patients who developed superficial thrombophlebitis	Pain score (10-point visual analogue score) Extent of erythema	14 days
Secondary	Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis		14 days
Secondary	Investigators' satisfaction	4-point rating scale	14 days
Secondary	Patient' satisfaction	4-point rating scale	14 days
Secondary	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
Secondary	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