VELSEAL - T: A phase 4 clinical trial to evaluate Safety and Efficacy of “VELSEAL - Tâ€to Achieve Haemostasis in Traumatic or Surgical Wound, both venous and arterial bleeds and after angiography / angioplasty.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- To evaluate the efficacy of the VELSEAL - T Device in controlling Haemorrhage from traumatic injuries, both venous and arterial bleeds and after angiography/ angioplasty.
研究概览
简要总结
This is an open label, phase 4 , single arm clinical trial with a primary objective of :
To evaluate the efficacy of the VELSEAL - T Device in controlling Haemorrhage from traumatic injuries, both venous and arterial bleeds and after angiography/ angioplasty.
and its secondary Objectives is
o Assessment of safety of device (adverse events)
o Assessment of Device success (defined as the percentage of first bleeding site applications for which hemostasis was obtained within 10 minutes of study device application).
o Assessment of Number of VELSEAL - T used on a single wound until complete haemostasis.
o To evaluate average time taken after application of VELSEAL - T device for control of Haemorrhage.
o Global assessment of study medications by Investigators.
Sample size calculation and study Hypothesis :
The studies conducted in Interventional Cardiology set-up to establish the safety and efficacy of the devices on basis of Events (haemorrhage, hematoma and abrasions) were found to be 7.2% in 400 subjects. This value is used for margin of error calculation; 0.05 Margin of error is for 95% CI.
To calculate performance goal, both margins are merged with the initial reference value and maximum event rate of 12.25% was obtained. Taking This value in reference, the proportion based Normal Curve was obtained on Minitab. The power of 80% is maintained on comparator p from 0.12 to 0.18. Hence, Proportion of population who continue with Haemorrhage at treated site beyond 10 minutes was planned to be less than 16%. This value was set as a performance Goal (Alternate Hypothesis: less than).
Thus Null Hypothesis was set as
H0 = M1 – M2 = 0,
where M2 is actual proportion of events and M1 is performance goal = 16% Alternate Hypothesis was set as:
H1 = M1-M2 > 0 With this the calculated sample size at 95% CI, upper bound and 80% power was 100. Adding 20% drop-outs, the final sample is calculated as 120.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
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.
- •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
- •Subjects who present with medical emergency, where treatment is more priority than the informed consent process.
- •Subjects who cannot provide informed consent such as unconscious subjects.
- •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.
- •Subjects with haematocrit less than 38% or haemoglobin less than 10 gm%.
- •Subjects with known haemorrhagic disorders like GI bleeding, Ante partum haemorrhage, metropathia haemorrhagica, history of haematemesis, haematuria, epistaxis etc.
- •Known cases of genetic bleeding disorder.
- •Subjects who have platelet count one thousand or more below the lower normal limit.
- •Subjects with known possible loss of plasma or blood from other areas than wound such as lacerations, uterine bleeding, gastro-intestinal bleeding etc.
- •The subject has an active infection at the surgical site.
结局指标
主要结局
To evaluate the efficacy of the VELSEAL - T Device in controlling Haemorrhage from traumatic injuries, both venous and arterial bleeds and after angiography/ angioplasty.
时间窗: with in 10 minutes of application of Velseal-T
次要结局
- a. Proportion of population demonstrating failure of hemorrhage control within 20 minutes after VELSEAL-T application.(b. Proportion of population demonstrating secondary hemorrhage after removal of VELSEAL-T.)