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

NCT01943006 | Completed Phase 3

• 1 other identifier: Hir-901113
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Number of patient developing superficial thrombophlebitis

  7 days

Secondary Outcomes (7)

• Time to develop infusion related superficial thrombophlebitis

  7 days

• Change of clinical symptoms in patients who developed superficial thrombophlebitis

  14 days

• Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis

  14 days

• Investigators' satisfaction

  14 days

• Patient' satisfaction

  14 days

Other Outcomes (7)

• Fasting blood glucose (FBS)

  14 days

• Platelet, red blood cell and leukocyte count

  14 days

• Alanine transaminase (ALT),

  14 days

Study Arms (2)

Hirudoid cream

EXPERIMENTAL

Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily

Drug: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate

Placebo

PLACEBO COMPARATOR

Patients treated with placebo cream without active substance Twice daily

Drug: Placebo cream without active substance

Interventions

Hirudoid cream 0.3 % Mucopolysaccharide polysulfate DRUG

Hirudoid cream

Hirudoid cream

Placebo cream without active substance DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Medinova AG: lead

Study Sites (4)

Siriraj Hospital

Bangkok, 107000, Thailand

Location

Chulalongkorn Hospital

Bangkok, Thailand

Location

Rajvithi Hospital

Bangkok, Thailand

Location

Bamrasnaradua Infectious Diseases Institute

Nonthaburi, Thailand

Location

MeSH Terms

Conditions

Thrombophlebitis; Phlebitis

Interventions

mucopolysaccharide polysulfate

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Vasculitis

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 16, 2013
• Study Start: May 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

TH (4)