SURVIVAL AND FUNCTIONALITY EVALUATION IN VITRO IN CRYOPRESERVED PLATELETS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 281
- 试验地点
- 4
- 主要终点
- survival of cryopreserved platelets greater than 28 days
研究概览
简要总结
Platelets correspond to one of the most widely used blood components in transfusion medicine, given their importance in the prevention of bleeding disorders in patients with multifactorial thrombocytopenia and non-immunological etiology, as well as in the management of traumatic or blood-related bleeding. surgical treatments. Given its wide margin of use and the constant demand for it for use within the different management schemes and procedures associated with the medical act, it is the objective of both hemotherapy services and blood banks and blood products to have availability component constant to meet such requirements. The main problem of this resource is its short useful life (5 to 7 days) which limits its availability, especially in the Latin American context where the production of blood components as well as the resources allocated for this purpose by state entities to blood banks are generally limited. Cryopreservation at -80 ° C using Dimethylsulfoxide as a preservative solution is a technique used since the 1950s to prolong platelet survival, the improvement of which has been remarkable in recent years, thus constituting an alternative for the resolution of this problem.
详细描述
HYPOTHESIS: Through cryopreservation it is possible to prolong the survival time of platelets up to 4 times, compared to those preserved under the conventional method, maintaining a viability equal to or greater than 50%.
There is a direct relationship between survival time, viability and functionality of cryopreserved platelets depending on the model of cryoprotective solution used.
PRIMARY OUTCOME: survival of cryopreserved platelets greater than 28 days SECUNDARY OUTCOME: viability of cryopreserved platelets greater than 50%
INCLUSION CRITERIA: Concentrates from donors over 18 years of age who meet the requirements established by law 22990 (Of Argentine Republic) for donating blood and blood components will be included in this study, from whom a number of platelets greater than or equal to 3 x10 E11 can be collected.
EXCLUSION CRITERIA: Platelet concentrates that present any of the following characteristics will be excluded from the investigation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Cryopreserved samples will be labeled with a code unknown to the researcher and those who process the sample in the laboratory.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Concentrates from donors over 18 years of age who meet the requirements established by law 22990 for donating blood and blood components will be included in this study, from whom a number of platelets greater than or equal to 3 x10 E11 can be collected
排除标准
- •Platelet concentrates that present any of the following characteristics will be excluded from the investigation:
- •Concentrates that have not met all of the standards required for use in humans or that at the time of the study more than 24 hours have passed since they were obtained.
结局指标
主要结局
survival of cryopreserved platelets greater than 28 days
时间窗: Between 1 and 3 months
次要结局
- viability of cryopreserved platelets greater than 50%(Between 1 and 3 months)
研究者
JHON ALEXANDER AVILA RUEDA
Specialist in Internal Medicine an Hematology
HOSPITAL BRITANICO DE BUENOS AIRES