Health Condition 1: R58- Hemorrhage, not elsewhere classified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Yoshivam Pharma LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants of all age groups and both genders will be included 2.Patients presenting with external bleeding due to trauma, injuries, or minor procedures 3.Patients with external bleeding ranging from mild to severe intensity, including trauma-related bleeding 4.Patients managed in OPD, IPD, procedural, or emergency/trauma settings 5.Patients or legally acceptable representatives who provide informed consent
Exclusion criteria
Exclusion criteria: 1.Patients with internal bleeding or requiring immediate surgical intervention 2.Known hypersensitivity/allergy to any component of the product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving effective bleeding control within 5 minutes of Hemoflavin Gel application across different bleeding severity categories.Timepoint: Proportion of patients achieving effective bleeding control within 5 minutes of Hemoflavin Gel application across different bleeding severity categories. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to bleeding control (in minutes), including analysis stratified by bleeding severity Estimated reduction in blood loss, as assessed by the treating clinician Proportion of patients (including those with severe bleeding) achieving bleeding control without escalation to advanced interventions Requirement for additional interventions, including suturing, pressure dressing, cauterization, surgical management, or transfusion Clinical stabilization at initial point of care, as assessed by the treating clinician Survival status at hospital admission in patients presenting with moderate to severe bleeding Ease of use, as assessed by healthcare personnel using a predefined rating scale Incidence of adverse events (local and/or systemic) Timepoint: Time to bleeding control(in minutes) | — |
Countries
India
Contacts
Public ContactTanvi Patil
Sangvi Multispeciality Hospital
Outcome results
None listed