DETERMINATION OF OPTIMAL PROPHYLACTIC PLATELET DOSE STRATEGY TO PREVENT BLEEDING

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 随着血小板使用量持续高速增长，确定最具成本效益的血小板支持策略至关重要，这对有效的疾病管理至关重要。每次输血应给予的最佳血小板量仍不确定，也没有进行前瞻性血小板输注试验。 本研究将调查三种不同给药策略对因干细胞移植或化疗导致血小板减少的住院患者的安全性。我们将测量每种方法在预防相当少量出血方面的有效性。 这项试验的结果可能会对标准医疗实践产生重大影响。 血小板剂量试验是一项多中心试验，将在美国招募1,350名患者。 患者将随机接受以下剂量之一：低于常规剂量的血小板，中等、相当常规剂量或高于常规剂量。 他们将在早晨血小板计数福尔斯低于10，000的任何时候接受血小板。 如果输注后血小板计数不超过10，000，医生可以安排另一次血小板输注，但不需要这样做。该方案还允许在需要进行手术或有活动性出血时给予额外的血小板。 研究工作人员将通过患者体格评估、患者访谈以及患者病历和实验室数据审查，每天进行出血评估。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. As platelet use continues to increase at a high rate, it is important to identify the most cost-effective strategies for providing platelet support, which is crucial for effective disease management. The optimal quantity of platelets that should be given per transfusion remains uncertain, and no prospective platelet transfusion trials have been performed. This study will investigate the safety of three different dosing strategies for inpatients with low platelets due to stem cell transplants or chemotherapy. We will measure how effective each of these is in prevention of a fairly low amount of bleeding. The results of this trial could have a major effect on standard medical practice. The Platelet Dose Trial is a multi-site trial that will enroll 1,350 patients in the United States. Patients will randomly receive one of the following: a lower dose of platelets than usual, a medium, fairly usual dose or a higher than usual dose. They will receive platelets any time their morning platelet count falls below 10,000. If the post-transfusion platelet count is not over 10,000, the physician will be able to order another platelet transfusion but is not required to do so. The protocol also allows for additional platelets to be given when procedures need to be done or when there is active bleeding. Assessment of bleeding by study personnel will be performed daily by means of physical assessment of the patient, patient interview and review of patient chart and laboratory data.