CTRI/2018/02/012239已完成4 期
VELSEAL - T: A phase 4 clinical trial to evaluate Safety and Efficacy of â??VELSEAL - Tâ??to Achieve Haemostasis in Traumatic or Surgical Wound, both venous and arterial bleeds and after angiography / angioplasty. - VELSEAL-T
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Males and females above 18 years of age who require haemostasis control for traumatic injuries, both venous and arterial bleeds and after angiography/angioplasty.
- •2.Subjects who can provide informed consent form in writing and medically in a position to undergo consent and screening processes.
- •3. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
排除标准
- •1. Subjects who present with medical emergency, where treatment is more priority than the informed consent process.
- •2. Subjects who cannot provide 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 haematocrit less than 38% or haemoglobin less than 10 gm%.
- •5. Subjects with known haemorrhagic disorders like GI bleeding, Ante partum haemorrhage, metropathia haemorrhagica, history of haematemesis, haematuria, epistaxis etc.
- •6. Known cases of genetic bleeding disorder.
- •7. Subjects who have platelet count one thousand or more below the lower normal limit.
- •8. Subjects with known possible loss of plasma or blood from other areas than wound such as lacerations, uterine bleeding, gastro-intestinal bleeding etc.
- •9. The subject has an active infection at the surgical site.
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