DETERMINATION OF OPTIMAL PROPHYLACTIC PLATELET DOSE STRATEGY TO PREVENT BLEEDING

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 随着血小板使用量继续以较高的速度增长，确定提供血小板支持的最具成本效益的策略非常重要，这对于有效的疾病管理至关重要。每次输血应该给予的最佳血小板数量仍然不确定，也没有进行预期的血小板输注试验。 这项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的低血小板住院患者的安全性。我们将测量每一种方法在预防相当少量的出血方面的有效性。这项试验的结果可能会对标准的医疗实践产生重大影响。 血小板剂量试验是一项多地点试验，将在美国招募1350名患者。患者将随机接受以下其中一种：低于正常剂量的血小板、中等剂量的、相当正常的剂量或高于正常剂量的。每当早晨的血小板数量降至10,000以下时，他们就会收到血小板。如果输血后的血小板数量不超过10,000个，医生可以下令再次输注血小板，但不是必须这样做。该方案还允许在需要进行手术或出现活动性出血时给予额外的血小板。 研究人员每天将通过对患者的身体评估、患者访谈以及审查患者病历和实验室数据来评估出血情况。

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.