EUCTR2008-000072-25-GB进行中（未招募）1 期
A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis during Peripheral Vascular Surgery
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 312
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Signed written Informed Consent Form (ICF)
- •2) Male or female
- •3) At least 18 years of age with no upper age limit
- •4) Willingness and ability to complete all protocol requirements
- •5) Hemoglobin (Hgb) = 9.0 g/dL
- •6) Platelet count above 70x103/mm3
- •7) Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure.
- •8) Require one of peripheral vascular procedures listed below involving either an arterial patch angioplasty or an arterial anastomosis utilizing PTFE or Dacron grafts, according to the Investigator’s selection:
- •Carotid endarterectomy requiring patch angioplasty
- •Carotid-subclavian bypass grafting
- •Axillo-femoral bypass grafting
- •Abdominal aortic aneurysm resection and graft replacement
- •Aorto-mesenteric bypass grafting
- •Aorto-celiac bypass grafting
- •Aorto-uni-iliac bypass grafting
- •Aorto-bi-iliac bypass grafting
- •Aorto-uni-femoral bypass grafting
- •Aorto-bi- femoral bypass grafting
- •Iliac aneurysm resection and graft replacement
- •Femoral aneurysm resection and graft replacement
- •Femoral-femoral bypass grafting
- •Femoral-popliteal bypass grafting
- •Renal arterial revascularization (bypass grafting)
- •Renal arterial revascularization (endarterectomy with patch angioplasty)
- •Popliteal artery revascularization (bypass grafting)
- •Popliteal artery revascularization (endarterectomy with patch angioplasty)
- •Femoral endarterectomy with patch angioplasty
- •Ilio-femoral bypass grafting.
- •9)Intra-operative inclusion criterion:
- •- A Target Bleeding Site (TBS) can be identified according to the Investigator’s judgment, and
- •- The TBS has a mild or moderate arterial bleeding according to the Investigator’s judgment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Have a pre-operative international normalized ratio (INR) = 2.0
- •2)Have a pre-operative aPTTratio = 1.5
- •3)Have a pre-operative serum creatinine > 2 times upper limit of normal (ULN) laboratory range
- •4)Have a pre-operative AST or ALT > 2.5 times ULN laboratory range
- •5)Are undergoing a re-operative procedure
- •6)Have an infection in the anatomic surgical area
- •7)Have a history of severe (e.g. anaphylactic) reactions to blood or any blood-derived product
- •8)Are unwilling to receive blood products
- •9)Are unlikely to adhere to the protocol requirements, or to be cooperative during the study conduct
- •10)Have a positive bleeding history
- •11)Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit.
- •12)Are females who are pregnant or nursing a child
- •13)Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit.
- •14)Were previously included in this clinical trial
- •15)Intra-operative exclusion criteria:
- •- A TBS cannot be identified according to the Investigator’s judgment, or
- •- The TBS has a severe arterial bleeding according to the Investigator’s judgment
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