Experimental Protocol for the Infusion of Platelets,Cryopreserved With Dimethyl Sulphoxide (DMSO) and Obtained From Multiple Donors Buffy Coats, in Patients With Severe Thrombocytopenia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion)
研究概览
简要总结
The increasing need for blood components and the increasingly careful donor selection procedures, make the availability of blood components very reduced, in particular for platelets that are currently administered preferably "fresh" or cryopreserved, only in emergency conditions.
Exceeding this limit through the spread of use of cryopreserved platelets in the common clinical practice, might help clinicians to avoid wasting valuable products and face periods of particular shortage of donors Some studies already published in the literature over the last decade (1,2) have demonstrated the safety and efficacy of autologous cryopreserved platelets .
The main objective of the proposed study is to evaluate the efficacy and safety of platelets, cryopreserved with DMSO using a a new method, in patients with severe thrombocytopenia.
This is the in vivo phase of a study where availability and efficacy of cryopreserved platelets has been assessed in vitro.
详细描述
The primary objective of the study is to evaluate the hemostatic efficacy and safety in the recipients of platelets obtained from buffy coat of multiple donors (five), cryopreserved with DMSO using a new patented method, up to 9 months from the collection.
Further goals are the registration of any related- adverse event (idiosyncrasy, allergy, toxicity)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cryopreserved buffy coat pooled platelets will be infused, after being thawed, in inpatients at U.O. of Hematology -Policlinic "P. Giaccone"-Palermo, falling into one of the following categories:
- •Stable clinical conditions and no complications with platelets ≤ 10,000/microliter;
- •With active bleeding and ≤ 20,000 platelets/microliter;
- •In the presence of: high blood pressure, high fever, rapid drop in platelets, infection, chemotherapy, coagulation abnormalities with ≤ 20,000 platelets/microliter.
排除标准
- •Suffering from congenital immunodeficiency
- •Allogeneic bone marrow transplant candidates
- •Bone Marrow Donors for transplantation
- •Undergoing bone marrow transplant or
- •Suffering from Hodgkin's disease and treated with purine analogues (Fludarabine, cladribine)
研究组 & 干预措施
Patients with severe thrombocytopenia
Intervention Patients with severe thrombocytopenia with an active bleeding, in preparation for surgery, or after chemotherapy (prophylaxis of bleeding),will receive transfusion of Pooled Platelets Cryopreserved In DMSO With a New System
干预措施: Transfusion of Pooled Platelets Cryopreserved In DMSO (Biological)
结局指标
主要结局
Efficacy of infused cryopreserved platelets (changes in platelets count will be determined at 1 hour and 24 hours post-transfusion)
时间窗: 1 Hour and 24 hours post-transfusion
To evaluate the availability of cryopreserved platelets after transfusion, the correct count (the number of platelets poured and the body surface, BMI, recipient) of platelets will be determined at 1 hour and 24 hours post transfusion, respectively
次要结局
- Safety of cryopreserved platelets(During transfusion and within 48 hours after transfusion)
研究者
Napolitano Mariasanta
Assistant Professor (ricercatore td)
University of Palermo