A Clinical Trial to study effect of heparin sodium topical solution inprevention of infusion associated phlebitis.
- Conditions
- Health Condition 1: null- patients undergoing cannulation of peripheralvein that has been planned to remain in situ for at least 72 hours of indoor period
- Registration Number
- CTRI/2017/03/008263
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 374
1.Either gender, age 18 to 65 years, both inclusive
2.Undergoing peripheral vein cannulation that has been planned to remain in situ for at least 72 hours of indoor period
3.Willing & able to comply with study requirements, e.g. regular application of IP and efficacy-safety evaluation schedule, as
indicated by written informed consent provided by the patient.
4.If female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing
to maintain reliable birth control throughout the study.
1.Undergoing re-cannulation due to phlebitis at earlier cannulation site
2.Unconscious or comatose patients
3.History of hypersensitivity reaction to heparin or heparin induced thrombocytopenia
4.Planned administration of any of the following during study period:
? Anti-coagulants locally (at IV site or in the cannula) or
systemically
? NSAIDs locally at IV site
5.Patients having participated in any clinical trial within last 30 days at the time of screening
6.Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method