ACCEL® Absorbable Hemostat Powder Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 10
- 主要终点
- Determination of incidence of SADE and ADE
研究概览
简要总结
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge, for achieving hemostasis in subjects undergoing cardiovascular, liver, or soft tissue surgery, when control of oozing to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Sealed, blinded envelopes will be provided by the Sponsor (Hemostasis LLC). The Investigator/designee only opens the randomization envelope after the subject has been deemed eligible for the study and an eligible TBS has been identified in order to reduce potential bias.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-Surgery:
- •Subject is greater than or equal to 22 years old
- •Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical procedure
- •Subject is willing and able to provide appropriate (Institutional Review Board (IRB) approved) informed consent.
- •The subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule.
- •The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
- •The subject is willing to be treated with a commercially available absorbable gelatin sponge
- •During Surgery:
- •Subject has not received blood transfusions between screening and application of investigational product or commercially available absorbable gelatin sponge
- •There is an estimated TBS surface area of ≤ 60 cm2
- •Visual observation of oozing (0.01 g/10s ˂ Flow ˂ 0.04 g/10s), mild (0.04 g/10s ≤ Flow ˂ 0.32 g/10s), or moderate (0.32 g/10s ≤ Flow ˂ 1.01 g/10s) bleeding as validated and when control by conventional surgical techniques, including but not limited to suture, ligature and cautery, is ineffective and/or impractical
- •There is an absence of intra-operative complications other than bleeding, which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety
- •There has been no intra-operative use of adjunct hemostat(s) on the target bleeding site identified for application of the study treatment
排除标准
- •Pre-Surgery:
- •The subject is pregnant (verified in a manner consistent with institution's standard of care)
- •Subject is lactating
- •Subject is currently participating in another investigational device or drug trial or has participated in one in the past 4 weeks (prior to surgery) or is planning to participate in another research study involving any investigational product within 4 weeks after surgery
- •Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
- •Subject has medical, social, or psychosocial issues that the Investigator believes could impact the subject's safety or compliance with study procedures
- •Subject has a known allergy to potatoes
- •Subject has a known allergy to porcine collagen/gelatin
- •Subject has a religious or other objection to porcine products
- •Subject is unwilling to receive blood products
- •Subject has history of heparin-induced thrombocytopenia (only for cardiovascular subjects where heparin use is required)
- •Subject with a baseline abnormality of INR > 2.5 or an aPTT> 100 seconds during screening that is not explained by current drug treatment (e.g. heparin, warfarin, etc.).
- •Subjects with platelets < 100 X 109 PLT/L during screening
- •Subject with Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) > 3 X upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit normal for these analytes due to the nature of their disease
- •Subject is unwilling or unable to return for the required follow-up after surgery
- •During Surgery:
- •Subject has an operative bleeding site which the surgeon is unable or unwilling to control with a hemostatic agent
- •Extracorporeal cardiopulmonary bypass circuits or blood salvage circuits are to be used during or after identification of the TBS.
- •There has been intra-operative use of thrombin on the patient.
结局指标
主要结局
Determination of incidence of SADE and ADE
时间窗: Through the six (6) week follow-up.
The analysis and comparison of the incidence of SADEs and ADEs through the six (6) week follow-up endpoint for the ACCEL® Absorbable Hemostat Powder and the control hemostat.
Demonstration of non-inferiority
时间窗: Day 0 / Surgery
Comparison of the percentage of subjects achieving hemostasis within three (3) minutes for cardiovascular surgery and within five (5) minutes for liver surgery and soft tissue surgery of the TBS using the ACCEL® Absorbable Hemostat Powder as compared to the control hemostat.
次要结局
- Individual subject success rate(Through the six (6) week follow-up.)
- Determination of TTH(Day 0 / Surgery)
- Length of individual subject hospitalization(Through the post-surgical follow-up (Day 1-7))