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临床试验/NCT04496700
NCT04496700已完成不适用

Transfusion of Whole Blood to Military Forces in a Combat Situation

Haukeland University Hospital4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
4
主要终点
Number of hits

研究概览

简要总结

During military action there might be situations where civil requirements for blood transfusion are not obtainable. Numerous warfare experiences suggest that administration of whole blood to a patient with uncontrollable bleeding/bleeding shock will improve survival in case of delayed evacuation.

Among Norwegian troops this gives one of two choices:

  1. A soldier donates blood to a wounded fellow soldier
  2. Personnel in safe distance donates blood and it is transported to the frontline.

Alternative b might implicate frequent donations and unused blood must be auto-re-transfused.

This study will investigate:

  1. Can 'buddy transfusion' in the field be justified also in medical aspects?
  2. Can repeated donations and auto-transfusions of transported whole blood into personnel(X) be justified also in medical aspects?

(X) Blood typed and screened for HIV, HBV, HCV, Syphilis before assignment

详细描述

MATERIALS AND METHODS

The study was approved by the research ethics committee of the Regional West Health Trust, Norway. Twenty-five nonsmoking male soldiers, median age 29 years, from a Navy special forces unit consented to participate. Mean body mass index was 24.7 kg/m2 (range, 22.6-28.3 kg/m2).

This is a pilot study and we were not able to find data in the literature providing information for power calculations regarding the testing we included in the study. The participants were divided in three different groups for testing. The grouping was based on availability at the given time points, and there was no selection to any specific group: Group 1-Bruce protocol treadmill stress test, push-ups, and pull-ups (n = 7); Group 2-50-round pistol shooting test (n = 12); and Group 3-uphill hiking exercise carrying a 20-kg backpack (n = 6). Each group was tested twice, before and immediately after donation of 450 mL of blood.

The soldiers were allowed to rehydrate during the donation procedure and theywere all offered a 0.5-L water bottle. The exact volume each participant consumed was not recorded. All 25 soldiers participated in a 60-minute training program aimed at testing whether it is possible to teach nonmedic soldiers buddy transfusion during a short period.

Multistage treadmill stress test, push-ups, and pull-ups

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Military personel deployable to combat situations

排除标准

  • General health issues

结局指标

主要结局

Number of hits

时间窗: Pre- and postdonation

The effect of whole blood donation on Combat Readiness Skills is evaluated by various tasks, among them a 50-round pistol shooting test (Standard Navy SOF protocol). The shooting test was performed before and immediately after donation of 450 ml whole blood. This outcome measure depicts number of hits in total, pre- and postdonation, respectively.

次要结局

  • Maximum heart rate (n/min)(Pre- and postdonation)
  • Minutes spent walking up and down the mountain Ulriken(Pre- and postdonation)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (4)

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