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一项使用健康志愿者将动力移植骨髓穿刺程序与手动标准骨髓穿刺程序进行比较的研究

2026年5月4日 更新者:Vidacare Corporation
这项单中心、随机、对照试验将在健康成年志愿者的髂嵴中使用手动标准骨髓抽吸装置与动力端口骨髓抽吸装置进行比较。 该研究将比较受试者的疼痛感知水平、样本采集时间以及这些设备的样本产量质量。 作为他们自己的控制,每个受试者将使用手动标准和电动端口设备接受双侧骨髓抽吸程序。

研究概览

详细说明

这项单中心、随机、对照试验将比较手动标准骨髓穿刺针与动力端口穿刺针在健康志愿者髂后嵴用于骨髓穿刺标本采集的情况。 该研究将比较设备样本产量的质量、受试者报告的针插入和抽吸疼痛程度,以及从针/皮肤接触到针插入和样本采集的时间。 每个受试者将作为他/她自己的对照,并将使用手动标准针和动力端口针接受双侧骨髓抽吸程序。 设备用于每个受试者程序的顺序以及每个设备将在哪一侧使用将是随机的。

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Texas
      • San Antonio、Texas、美国、78217
        • Medical Therapy and Research LLC.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 99年 (成人、年长者)

接受健康志愿者

是的

描述

纳入标准:

  • 21 岁及以上的成年人
  • 能够俯卧在桌子上长达 1 小时
  • 自我报告健康,经研究者在病史回顾和体格检查中确认
  • 筛查访视时尿妊娠试验阴性的女性受试者

排除标准:

  • 筛选访视后 7 天内报告发烧
  • 筛查访视后 7 天内报告活动性感染
  • 研究程序当天发烧
  • 研究程序当天活动性感染的体征/症状
  • 入狱
  • 自我认定为怀孕或哺乳期
  • 认知障碍
  • 患有一种或多种无法进行骨髓穿刺的疾病的患者
  • 目标骨中组织过多和/或缺乏足够的解剖学标志
  • 对局部麻醉剂过敏
  • 俯卧时无法平躺
  • 凝血酶原时间和国际标准化比率 (PT/INR) 结果超出筛选实验室工作的正常范围,并且被研究者认为具有临床意义

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
其他:Group 1: First Procedure: Jamshidi Manual Standard Device
The Jamshidi manual standard device procedure will be performed first. The OnControl Powered Ported device procedure will be performed second.
Jamshidi 手动标准装置
OnControl 供电的移植设备
其他:Group 2: First Procedure OnControl Powered Ported Device
The OnControl power ported device procedure will be performed first. The Jamshidi manual standard device procedure will be performed second.
Jamshidi 手动标准装置
OnControl 供电的移植设备

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device
大体时间:analyzed and results received within 30 days of Day 1 procedures

The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality.

Direct Smears- Cellularity:

0= obviously dilute, no good particles or adequate megakaryocytes (MK)

  1. probably slightly dilute, particles and MK present
  2. cellular, good particles; MK present on edge, smears reflect clot section cellularity

Particle Crush Smears: Evaluate presence of particles and quality of cellularity:

0= no particles

  1. few particles; difficult to evaluate marrow cellularity and adequacy of MK
  2. good particles; adequate material to evaluate MK
  3. many particles, some large, with MK easily evaluated

Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation

  1. few small particles; difficult to determine cellularity
  2. several particles, good marrow cellularity
  3. numerous particles (some large); easy to assess cellularity and cell composition
analyzed and results received within 30 days of Day 1 procedures
Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device
大体时间:analyzed and results received within 30 days of Day 1 procedures

The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality.

Direct Smears- Cellularity:

0= obviously dilute, no good particles or adequate megakaryocytes (MK)

  1. probably slightly dilute, particles and MK present
  2. cellular, good particles; MK present on edge, smears reflect clot section cellularity

Particle Crush Smears: Evaluate presence of particles and quality of cellularity:

0= no particles

  1. few particles; difficult to evaluate marrow cellularity and adequacy of MK
  2. good particles; adequate material to evaluate MK
  3. many particles, some large, with MK easily evaluated

Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation

  1. few small particles; difficult to determine cellularity
  2. several particles, good marrow cellularity
  3. numerous particles (some large); easy to assess cellularity and cell composition
analyzed and results received within 30 days of Day 1 procedures

次要结果测量

结果测量
措施说明
大体时间
Level of Pain With Needle Insertion- Jamshidi Manual Standard Device
大体时间:Day 1 at time of procedure
Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain.
Day 1 at time of procedure
Level of Pain With Needle Insertion- OnControl Power Ported Device
大体时间:Day 1 at time of procedure
Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain.
Day 1 at time of procedure
Level of Pain With Aspiration - Jamshidi Manual Standard Device
大体时间:1 Day at time of the procedure
Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain.
1 Day at time of the procedure
Level of Pain With Aspiration - OnControl Power Ported Device
大体时间:1 Day at time of the procedure
Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain.
1 Day at time of the procedure
Time to Insertion - Jamshidi Manual Standard Device
大体时间:1 Day, during procedure
Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space
1 Day, during procedure
Time to Insertion - OnControl Power Ported Device
大体时间:1 Day, during procedure
Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space
1 Day, during procedure
Time for Aspirate Collection - Jamshidi Manual Standard Device
大体时间:1 Day, during procedure
Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition
1 Day, during procedure
Time for Aspirate Collection - OnControl Power Ported Device
大体时间:1 Day, during procedure
Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition
1 Day, during procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年12月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2014年11月17日

首先提交符合 QC 标准的

2014年11月21日

首次发布 (估计的)

2014年11月24日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2014-12 (AP HM)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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