Health Condition 1: null- Haemophilia Patients with External Bleeding Health Condition 2: D66- Hereditary factor VIII deficiency
Conditions
Interventions
Control Intervention1: NIL: Nil
Sponsors
Dr Anupam Dutta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients above 18 years of age with haemophilia disorders who require haemostasis control. 2. Patients who can provide informed consent form in writing and medically in a position to undergo consent for data collection. 3. Subjects willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
Exclusion criteria
Exclusion criteria: 1. Subjects with medical emergency, where treatment is the priority than the informed consent process and his/her representative deny to participant in the study. 2. Subjects who cannot provide the informed consent such as unconscious subjects. 3. The subjects who have been treated with other higher treatment for Haemorrhage control such as Tourniquets for more than 2 hours, Blood or platelet-rich-plasma transfusion etc. 4. Subjects with known possible loss of plasma or blood from other areas than wound such as lacerations, Uterine bleeding, Gastro-intestinal bleeding etc. 5. Subjects with an active infection at the injury site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To observe the hemostatic efficacy of VELSEAL-T on haemophilia subjects with external bleeding to control haemorrhage.Timepoint: 12 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of number of VELSEAL-T-T used on a single wound until complete haemostasis. 2. Assessment of VELSEAL-T related adverse events. 3. To evaluate average time taken after application of VELSEALââ?¬â??T to control haemorrhage. 4. Assessment of VELSEAL-T device w.r.t available options.Timepoint: 4 hours | — |
Countries
India
Contacts
Public ContactDr Anupam Dutta
Assam Medical College and Hospital
Outcome results
None listed