Haemorrhagic Control Effectiveness of ACUCLOT- Biopolymer based Haemostatic Sponge in Acute Haemorrhage due to Trauma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of “AcuClot- Biopolymer based Haemostatic Sponge†(Anziam
研究概览
简要总结
This study aims to assess the effectiveness and safety of ACUCLOT Biopolymer Hemostatic Sponge in controlling acute hemorrhage due to trauma. ACUCLOT is a biopolymer-based, non-absorbable hemostatic sponge designed to stop moderate to severe bleeding rapidly. This trial will evaluate the product’s efficacy in both out-hospital and in-hospital settings, focusing on metrics such as time to achieve hemostasis, blood loss, rebleeding incidents, and other side effects. The study will enroll 50 adult participants with trauma-induced hemorrhage and compare ACUCLOT’s performance against conventional cotton gauze, with assessments made at baseline and follow-up after 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Each patient must meet all of the following criteria to be enrolled in the study:
- •Both Male and Female aged more than and equals to 18 years to less than 65 years.
- •Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to enrollment.
- •Be with Accessible Traumatic Bleedings/Haemorrhage
- •Wound must be bleeding actively at the time of baseline assessment
- •Wound size should be covered by a single available size of study device
- •Subjects willing to comply with the protocol requirements.
排除标准
- •Subjects with any of the following conditions will be excluded from the study:
- •Patients who had a prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia);
- •A non-survivable injury as per the investigator’s discretion;
- •Patients who, in the opinion of the investigator, may not complete the study for any reason (e.g., patients requiring immediate suturing);
- •Grossly infected wounds which may require multiple debridement procedures prior to clearance of bacteria;
- •Patients currently participating in an investigational drug or device study that had not yet completed its primary endpoint or interfered with procedure and assessments in this study;
- •Patients with a surgical/iatrogenic wound;
- •Patients with a major head injury, spinal injury, neck injury, abdominal injury, deep wound injury, fracture, hemorrhagic shock, or foreign materials inside the wound, such as a stab injury.
结局指标
主要结局
Evaluate the efficacy of “AcuClot- Biopolymer based Haemostatic Sponge†(Anziam
时间窗: Visit 1 (Day 1 ) and Visit 2 (Day 2)
Bio Private Limited, Rajasthan India), as a haemorrhage control device in the OutHospital and In-Hospital Settings.
时间窗: Visit 1 (Day 1 ) and Visit 2 (Day 2)
次要结局
- Evaluate the safety of “AcuClot- Biopolymer based Haemostatic Sponge†(Anziam Bio(Private Limited, Rajasthan India), as a haemorrhage control device in the Out-Hospital and In-Hospital Settings.)
研究者
Dr Katam Ram Kumar Reddy
Mahatma Gandhi Memorial Hospital