A Clinical Trial to study effect of heparin sodium topical solution inprevention of infusion associated phlebitis.

Phase 3

Completed

• Conditions: 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

A prospective, randomized, double blind, placebo controlled, parallel group, multicenter, clinical study to evaluate safety and efficacy of Phlebotroy QPS (heparin sodium topical solution) 1000 IU/ ml in prevention of infusion associated phlebitis.

**Primary efficacy end point:** Both treatments will be compared forï‚· Incidence of infusion phlebitis (grade II & above) during 72 hours of treatment period

**Secondary efficacy end points:** Both treatments will be compared for 1. Mean time to develop infusion phlebitis (grade II or above) in hours. For patients not reaching grade II by 72 hours, it will be 72 hours. 2. Mean maximum intensity of pain experienced by patients at IV site recorded on 100 mm Visual Analogue Scale (VAS) during 72 hours of treatment period. 3. Incidence of first signs of phlebitis (grade I) 4. Mean time to develop infusion phlebitis grade I (or above) in hours

**Safety endpoints:**ï‚· Incidence of treatment emergent (probably or certainly associated with study treatment as per WHO causality assessment) application site reactions.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-05
• Study Completion: 2019-03-01
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

• 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.

Exclusion Criteria

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: ï‚· Anti-coagulants locally (at IV site or in the cannula) or systemically ï‚· 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
Incidence of infusion phlebitis (grade II & above) during 72 hours of	[every 8±1 hours for 72 hours starting | within 1 hour of cannulation, total 10 times
treatment period	[every 8±1 hours for 72 hours starting | within 1 hour of cannulation, total 10 times

Secondary Outcome Measures

Name	Time	Method
1. Mean time to develop infusion phlebitis (grade II or above) in hours.	For patients not reaching grade II by 72 hours, it will be 72 hours.

Trial Locations

Locations (7)

Apollo First Med Hospitals; 🇮🇳 Chennai, TAMIL NADU, India

Apollo Hospitals, Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

B Y L Nair Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Christian Medical College and Hospital, Ludhiana; 🇮🇳 Ludhiana, PUNJAB, India

Fortis Hospital, Ludhiana; 🇮🇳 Ludhiana, PUNJAB, India

IPGMER & SSKM, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Sheth VS general Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Apollo First Med Hospitals

🇮🇳Chennai, TAMIL NADU, India

Dr Major R S Rengan

Principal investigator

9841142294

dr.rsrengan@gmail.com