Topical Heparin for the prevention of Infusion Associated Superficial Venous Thrombophlebitis A prospective open label comparative clinical study

A PROSPECTIVE RANDOMIZED EVALUATOR BLINDED, ACTIVE CONTROLLED PARALLEL GROUP CLINICAL STUDY TO EVALUATE SAFETY AND EFFICACY OF HEPARIN SODIUM TOPICAL SOLUTION (1000 IU/ ML) COMPARED TO HEPARIN SODIUM (200 IU/ GM) TOPICAL GEL IN PREVENTION OF INFUSION ASSOCIATED PHLEBITIS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009499

Enrollment

100

Registered

2017-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- infusion associated superficial venous thrombophlebitis

Interventions

Intervention1: Phlebotroy QPS: heparin sodium 1000 iu per ml topical solution Control Intervention1: Thrombophob gel: heparin sodium 200 iu per gram topical gel

Eligibility

Inclusion criteria

Inclusion criteria: 1 Planned to undergo peripheral vein cannulation that has been planned to remain in situ for at least 72 hours of indoor period 2 Willing & able to comply with study requirements, e.g. application of IP and study visit schedule, as indicated by written informed consent provided by the patient. 3 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

Exclusion criteria: 1 Undergoing re-cannulation due to phlebitis at earlier cannulation site 2 History of hypersensitivity reaction to heparin or heparin induced thrombocytopenia 3 Signs of systemic infection, bacteremia 4 Planned administration of any of the following during study period Anti-coagulants locally (in the cannula) or systemically NSAIDs locally (in the cannula or over surrounding area)

Design outcomes

Primary

Measure	Time frame
1 Proportion of patients with no phlebitis (Grade 0) at the end of 72 hours of treatment period 2 Proportion of patients who developed first signs of infusion phlebitis (Grade I and II) during the 72 hours of treatment periodTimepoint: Enrolled patients will be periodically monitored by evaluator every 8 hours from cannulation for infusion phlebitis grade as per visual infusion phlebitis scale time points are 0 8 16 24 32 40 48 56 64 72	—

Measure

Time frame

1 Proportion of patients with no phlebitis (Grade 0) at the end of 72 hours of treatment period 2 Proportion of patients who developed first signs of infusion phlebitis (Grade I and II) during the 72 hours of treatment periodTimepoint: Enrolled patients will be periodically monitored by evaluator every 8 hours from cannulation for infusion phlebitis grade as per visual infusion phlebitis scale time points are 0 8 16 24 32 40 48 56 64 72

—

Secondary

Measure	Time frame
Mean time to reach infusion phlebitis grade I and II in hours based on the time point when patient was first found to have phlebitis grade I or II. Only the proportion of patients who developed grade I and II phlebitis were considered for the evaluation of mean time to develop grade I and II phlebitisTimepoint: time points are 0 8 16 24 32 40 48 56 64 72	—

Countries

India

Contacts

Public ContactDr Vikas Saini

PGIMER

vsainidr@gmail.com91-7087008119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026