Comparing Two Heparin Treatments to Reduce IV-Related Vein Inflammation in Children.

A Prospective Randomized Study on the Efficacy of Heparin QPS Solution and Heparin Gel in Preventing Superficial Thrombophlebitis in Children

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099004

Enrollment

120

Registered

2025-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: T801- Vascular complications following infusion, transfusion and therapeutic injection

Interventions

Intervention1: Topical heparin QPS: Heparin Quick Penetrating Solution (QPS) provides faster and deeper transdermal absorption than conventional gel Group A Heparin QPS (1000 IU/mL). Applied every 8

Eligibility

Inclusion criteria

Inclusion criteria: Age 1 to 12 years Those who require more than 48 h IV therapy

Exclusion criteria

Exclusion criteria: Heparin hypersensitivity, bleeding disorders, anticoagulant therapy, local infection, or critical illness requiring central lines.

Design outcomes

Primary

Measure	Time frame
Incidence of superficial thrombophlebitis assessed daily for 5 days or until cannula removal using the Visual Infusion Phlebitis (VIP) Score. Timepoint: It is assessed daily for 5 days or until cannula removal using the Visual Infusion Phlebitis (VIP) Score.	—

Secondary

Measure	Time frame
Secondary Outcomes is Time to onset of thrombophlebitis. Severity (graded by VIP score). Local adverse events (erythema, rash.). Expected Outcomes The study is expected to determine whether Heparin QPS solution provides superior protection against superficial thrombophlebitis compared to Heparin gel in pediatric patients.Timepoint: It is assessed daily for 5 days or until cannula removal using the Visual Infusion Phlebitis (VIP) Score.	—

Measure

Time frame

Secondary Outcomes is Time to onset of thrombophlebitis. Severity (graded by VIP score). Local adverse events (erythema, rash.). Expected Outcomes The study is expected to determine whether Heparin QPS solution provides superior protection against superficial thrombophlebitis compared to Heparin gel in pediatric patients.Timepoint: It is assessed daily for 5 days or until cannula removal using the Visual Infusion Phlebitis (VIP) Score.

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Countries

India

Contacts

Public ContactDr Alexander Mannu

chettinad hospital and research institute

paedsalex@gmail.com9551607900

Outcome results

None listed

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