跳至主要内容
临床试验/NCT03050502
NCT03050502招募中不适用

The Management of Traumatic Hemothoraces in Blunt Thoracic Injured Patients: A Randomized Clinical Trial

University of Calgary4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
4
主要终点
The numbers of hemothoraces that require thoracic interventions.

研究概览

简要总结

Chest injuries are common in patients with polytrauma and are responsible for approximate 25% of all trauma-related mortalities. Traumatic injuries to the thorax often result in the accumulation of blood within the chest (i.e. a hemothorax (HTX)). The management of HTX remains a clinical dilemma when the volume of blood is small to moderate and the patient is hemodynamically stable. The East American Association of Trauma guidelines suggest that all HTXs should be considered for chest tube drainage. However, a prospective observational study suggested small to moderate HTXs could be absorbed without intervention. Although HTXs are effectively managed with chest tube drainage of the blood (i.e. tube thoracostomy), this intervention is associated with numerous potential major complications, including injury and infection in up to 22% of patients. The purpose of this study is therefore to conduct a randomized controlled study to compare patients with traumatic HTX managed by chest tube drain or expectant management (close monitoring), to determine when a chest tube is needed and when it is not to treat hemothoraces. The results from this study will inform the care of future trauma patients who present with this common injury throughout the globe.

详细描述

Chest injuries are common in patients with polytrauma and are responsible for approximate 25% of all trauma-related mortalities. Traumatic injuries to the thorax often result in the accumulation of blood within the pleural space (i.e. a hemothorax (HTX)). The management of HTX remains a clinical dilemma when the volume of blood is small to moderate and the patient is hemodynamically stable. Prior to the ubiquitous use of chest computed tomography (CT), diagnosing quantities of blood <1000 mL was challenging (especially given inherent limitations in the standard chest radiograph (CXR)). With the widespread adoption of CT ''pan-scanning'' however, significantly more HTXs are being detected. The clinical significance and optimal treatment of these small to moderate HTXs remains unknown. Although HTXs are effectively managed with tube thoracostomy (TT) drainage of the pleural space (i.e. chest tube placement), this intervention is associated with numerous potential major complications, including iatrogenic injury, retained HTX, and empyema in up to 22% of patients. The East American Association of Trauma guidelines suggest that all HTXs should be considered for TT drainage. However, a prospective observational study suggested small to moderate HTXs could be absorbed without intervention. Classic studies from the 1960's also indicate that much larger quantities of blood can be reabsorbed without intervention as well. As a result, it is unclear if chest tubes are being over-utilized in patients who may not actually require them. Retrospective data from over 2,000 patients also suggests that many traumatic HTXs can be managed expectantly without TT drainage. Finally many small or occult HTXs (those not diagnosed by CXR, but later detected by CT scan) may also be safely observed, thus supporting the concept of expectant management (EM) for many HTXs with the goal of minimizing patient morbidity.

The Foothills Medical Centre recently reported a retrospective study including 635 patients with traumatic HTXs. Overall, 491 (66%) HTXs were drained while 258 (34%) were managed expectantly. Independent predictors of TT placement included concomitant ipsilateral flail chest or pneumothorax. It also became evident that clinical practice was not directly dependent on the specific size of the HTX. Although the adjusted odds of mortality were not significantly different between groups (OR 3.99; 95% CI 0.87-18.30; p = 0.08), TT was associated with a 47.14% (95% CI, 25.57-69.71%; p < 0.01) adjusted increase in hospital length of stay. Empyemas (n = 29) also only occurred among TT patients. The authors concluded that expectant management of traumatic HTX was associated with a shorter length of hospital stay, no empyemas, and no increase in mortality. Although EM of small HTXs appears safe and optimal, these findings must be confirmed by a larger randomized controlled trial. The purpose of this study is therefore to conduct a randomized controlled study to compare patients with traumatic HTX managed by TT or EM. Characterization of those HTXs that require pleural drainage versus those that can be managed conservatively will be optimally defined. The results from this study will inform the care of future trauma patients who present with this common injury throughout the globe.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 18 years
  • Blunt thoracic injury
  • CT detected hemothorax

排除标准

  • Hemodynamic instability that is related to HTX in the judgment of the attending clinician
  • Any scenario where the clinician mandates urgent TT placement
  • Penetrating thoracic injury
  • Respiratory distress that is related to HTX in the judgment of the attending clinician
  • Chest tube already in-situ (eg. Prior to transfer of care to the FMC)
  • >24 h after admission
  • Ipsilateral flail chest fracture pattern

结局指标

主要结局

The numbers of hemothoraces that require thoracic interventions.

时间窗: 1 year after patient recruited in the study

The rate of hemothoraces that require thoracic interventions in patients of both groups.

次要结局

  • The days of intensive care unit stay(30 days after patients recruited in the study)
  • The days of mechanical ventilation in intensive care unit(30 days after patients recruited in the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Chad G. Ball

Associate Professor

University of Calgary

研究点 (4)

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