Phlebitis, Thrombophlebitis
Conditions
Keywords
Mucopolysaccaride polysulfate (MPS), MPS, Heparinoide, Infusionphlebitis, Prevention, Superficial thrombophlebitis, Treatment
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.
Interventions
DRUGHirudoid cream 0.3 % Mucopolysaccharide polysulfate
Hirudoid cream
Sponsors
Medinova AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patient developing superficial thrombophlebitis | 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to develop infusion related superficial thrombophlebitis | 7 days | — |
| Change of clinical symptoms in patients who developed superficial thrombophlebitis | 14 days | Pain score (10-point visual analogue score) Extent of erythema |
| Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis | 14 days | — |
| Investigators' satisfaction | 14 days | 4-point rating scale |
| Patient' satisfaction | 14 days | 4-point rating scale |
| Number of adverse events | 14 days | Number of any adverse events and adverse drug reactions including their severity experienced by the patients during the course of therapy |
| Global tolerability | 14 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Platelet, red blood cell and leukocyte count | 14 days | Laboratory testing is performed on day 1 and end of study |
| Alanine transaminase (ALT), | 14 days | Laboratory testing is performed on day 1 and end of study |
| Aspartate transaminase (AST), | 14 days | Laboratory testing is performed on day 1 and end of study |
| Fibrinogen and activated partial thromboplastin time (aPTT) | 14 days | Laboratory testing is performed on day 1 and end of study |
| Prothrombin time (PT) | 14 days | Laboratory testing is performed on day 1 and end of study |
| Serum creatinine | 14 days | Laboratory testing is performed on day 1 and end of study |
| Fasting blood glucose (FBS) | 14 days | Laboratory test performed on day 1 and at the end of the study |
Countries
Thailand
Outcome results
None listed