CTRI/2017/10/009966
Completed
未知
An observational study to evaluate haemostasis action of VELSEAL-T in haemophilia patients with external bleeding
Dr Anupam Dutta0 sites48 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr Anupam Dutta
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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A study to learn more about bleeding episodes, the use of treatments containing a protein called clotting factor 8 (FVIII), and how the patients felt about their symptoms and pain, in people with hemophilia AHemophilia AMedDRA version: 20.0Level: LLTClassification code 10053753Term: Hemophilia A without inhibitorsSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2019-004480-48-NLBayer AG140