A Double-bline Safety and Efficacy Study Comparing Pad-gauze With Tranexamic Acid (Hemostopan™) to a Regular Pad-gauze in Controlling Bleeding in Patients on Hemodialysis.
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Time to hemostasis
研究概览
简要总结
Patients on chronic treatment with hemodialysis have an arterio-venous fistula which enable the insertion of two large gauge needles. At the end of dialysis the needles are extracted and continuous pressure is needed to stop the bleeding. Time to bleeding cessation is different between patients and may be up to 20 minutes. Acquired coagulopathy in patients on chronic hemodylasis is a well known entity. The coagulopathy is multi-factorial including uremic thrombocytopathia, the presence of anemia, the use of anti-platelets and/or anti-coagulation drugs and the regular use of heparin during dialysis. Tranexamic acid (Hexakapron) is an anti-fibrinolytic drug that has a proven efficacy in reducing blood loss at different clinical settings. The drug may be given systemically (PO/IV) or applied locally on the site of injury.
The aim of the study is to assess the efficacy and safety of a pad gauze dressing containing tranexamic acid.
Study design:
A Double-blind study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular pad-gauze. The type of dressing for each dialysis session will be decided in a random manner. In each dialysis session only one type of dressing will be used for both insertion points.
Protocol for applying the dressing:
Following the needle extraction either dressing "A" or "B" will applied with slight pressure for 2 minutes. If bleeding stops it will be the end of session.
If bleeding persists than another dressing of the same kind is applied with slight pressure for 4 minutes. If bleeding stops it will be the end of session.
If bleeding persists than another dressing of the same kind is applied with slight pressure for 6 minutes. If bleeding stops it will be the end of session.
If bleeding persists than it will be consider a failure and a regular measures will be used until bleeding stops.
Each session will be documented in the patient's case report file (CRF). The primary end point of the study: Time to bleeding cessation
详细描述
A Double-blind safety and efficacy study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular pad-gauze in controlling bleeding in patients on hemodialysis.
Background:
Patients with end-stage renal disease are on chronic treatment with hemodialysis. Most patients have and arterio-venous fistula which enable the insertion of two large gauge needles. At the end of dialysis the needles are extracted and continuous pressure is needed to stop the bleeding. Time to hemostasis is different between patients and may be up to 20 minutes for each insertion point. Acquired coagulopathy in patients on chronic hemodylasis is a well known entity which have an important impact on time to hemostasis. The coagulopathy is multi-factorial composed including uremic thrombocytopathia, the presence of anemia, the use of anti-platelets and / or anti-coagulation drugs and the regular use of heparin during the dialysis process. Tranexamic acid (Hexakapron) is an anti-fibrinolytic drug that has a proven efficacy in reducing blood loss at different clinical settings. The drug may be given systemically (PO / IV) or applied locally on the site of injury.
The aim of the study To study the efficacy and safety of a pad gauze dressing containing tranexamic acid.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that require at least 10 minutes for hemostasis
- •Patient over 18 years of age that are capable of signing an informed consent
排除标准
- •Patients with HIV, HCV or HBV chronic infection
- •Known hypersensitivity to polydine
结局指标
主要结局
Time to hemostasis
时间窗: 10 minutes
次要结局
未报告次要终点