To observe Haemophilia patients for control of external bleeding by using VELSEAL-T
- Conditions
- Health Condition 1: null- Haemophilia Patients with External BleedingHealth Condition 2: D66- Hereditary factor VIII deficiency
- Registration Number
- CTRI/2017/10/009966
- Lead Sponsor
- Dr Anupam Dutta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To observe the hemostatic efficacy of VELSEAL-T on haemophilia subjects with external bleeding to control haemorrhage.Timepoint: 12 minutes
- Secondary Outcome Measures
Name Time Method 1. Assessment of number of VELSEAL-T-T used on a single wound until complete haemostasis. <br/ ><br>2. Assessment of VELSEAL-T related adverse events. <br/ ><br>3. To evaluate average time taken after application of VELSEALââ?¬â??T to control haemorrhage. <br/ ><br>4. Assessment of VELSEAL-T device w.r.t available options.Timepoint: 4 hours