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

Primary Purpose

Thrombophlebitis, Phlebitis

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Hirudoid cream 0.3 % Mucopolysaccharide polysulfate

Placebo cream without active substance

About this trial

This is an interventional prevention trial for Thrombophlebitis focused on measuring Mucopolysaccaride polysulfate (MPS), MPS, Heparinoide, Infusionphlebitis, Prevention, Superficial thrombophlebitis, Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Siriraj Hospital
Chulalongkorn Hospital
Rajvithi Hospital
Bamrasnaradua Infectious Diseases Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hirudoid cream

Placebo

Arm Description

Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily

Patients treated with placebo cream without active substance Twice daily

Outcomes

Primary Outcome Measures

Number of patient developing superficial thrombophlebitis

Secondary Outcome Measures

Time to develop infusion related superficial thrombophlebitis

Change of clinical symptoms in patients who developed superficial thrombophlebitis

Pain score (10-point visual analogue score) Extent of erythema

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

Investigators' satisfaction

4-point rating scale

Patient' satisfaction

4-point rating scale

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

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

Full Information

NCT ID

NCT01943006

First Posted

September 6, 2013

Last Updated

December 12, 2017

Sponsor

Medinova AG

1. Study Identification

Unique Protocol Identification Number

NCT01943006

Brief Title

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

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medinova AG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombophlebitis, Phlebitis

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hirudoid cream

Arm Type

Experimental

Arm Description

Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients treated with placebo cream without active substance Twice daily

Intervention Type

Drug

Intervention Name(s)

Hirudoid cream 0.3 % Mucopolysaccharide polysulfate

Intervention Description

Hirudoid cream

Intervention Type

Drug

Intervention Name(s)

Placebo cream without active substance

Primary Outcome Measure Information:

Title

Number of patient developing superficial thrombophlebitis

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Time to develop infusion related superficial thrombophlebitis

Time Frame

7 days

Title

Change of clinical symptoms in patients who developed superficial thrombophlebitis

Description

Pain score (10-point visual analogue score) Extent of erythema

Time Frame

14 days

Title

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

Time Frame

14 days

Title

Investigators' satisfaction

Description

4-point rating scale

Time Frame

14 days

Title

Patient' satisfaction

Description

4-point rating scale

Time Frame

14 days

Title

Number of adverse events

Description

Number of any adverse events and adverse drug reactions including their severity experienced by the patients during the course of therapy

Time Frame

14 days

Title

Global tolerability

Description

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

Time Frame

14 days

Other Pre-specified Outcome Measures:

Title

Fasting blood glucose (FBS)

Description

Laboratory test performed on day 1 and at the end of the study

Time Frame

14 days

Title

Platelet, red blood cell and leukocyte count

Description