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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hirudoid cream | Experimental | Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate Twice daily |
|
| Placebo | Placebo Comparator | Patients treated with placebo cream without active substance Twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hirudoid cream 0.3 % Mucopolysaccharide polysulfate | Drug | Hirudoid cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient developing superficial thrombophlebitis | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to develop infusion related superficial thrombophlebitis | 7 days | |
| Change of clinical symptoms in patients who developed superficial thrombophlebitis | Pain score (10-point visual analogue score) Extent of erythema |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose (FBS) | Laboratory test performed on day 1 and at the end of the study | 14 days |
| Platelet, red blood cell and leukocyte count | Laboratory testing is performed on day 1 and end of study |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkok | 107000 | Thailand | |||
| Chulalongkorn Hospital |
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| ID | Term |
|---|---|
| D013924 | Thrombophlebitis |
| D010689 | Phlebitis |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C052717 | mucopolysaccharide polysulfate |
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| Placebo cream without active substance |
| Drug |
|
| 14 days |
| Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis | 14 days |
| Investigators' satisfaction | 4-point rating scale | 14 days |
| Patient' satisfaction | 4-point rating scale | 14 days |
| 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 |
| 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 |
| 14 days |
| Alanine transaminase (ALT), | Laboratory testing is performed on day 1 and end of study | 14 days |
| Aspartate transaminase (AST), | Laboratory testing is performed on day 1 and end of study | 14 days |
| Fibrinogen and activated partial thromboplastin time (aPTT) | Laboratory testing is performed on day 1 and end of study | 14 days |
| Prothrombin time (PT) | Laboratory testing is performed on day 1 and end of study | 14 days |
| Serum creatinine | Laboratory testing is performed on day 1 and end of study | 14 days |
| Bangkok |
| Thailand |
| Rajvithi Hospital | Bangkok | Thailand |
| Bamrasnaradua Infectious Diseases Institute | Nonthaburi | Thailand |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D014657 | Vasculitis |