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The Management of Traumatic Hemothoraces (HemoTxRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050502
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Dr. Chad G. Ball, University of Calgary

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemothorax Thoracic Injuries Device: Chest tube drain Other: Expectant management Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Management of Traumatic Hemothoraces in Blunt Thoracic Injured Patients: A Randomized Clinical Trial
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Chest tube drain
A chest tube placed with the intent of draining all intra-pleural blood.
Device: Chest tube drain
This group will have an intra-pleural catheter placed with the intent of draining all intra-pleural blood (HTX). The size and nature of the catheter, manner of placement, and timing of removal will be at the discretion of the attending clinician.

Sham Comparator: Expectant management
No chest tube, but will undergo standard observation/conservative management by the trauma service.
Other: Expectant management
This group will not have an intra-pleural catheter placed on the basis of the HTX, but will undergo standard observation/conservative management by the trauma service. Intra-pleural catheters may be placed after enrollment at the attending clinician's discretion.




Primary Outcome Measures :
  1. The numbers of hemothoraces that require thoracic interventions. [ Time Frame: 1 year after patient recruited in the study ]
    The rate of hemothoraces that require thoracic interventions in patients of both groups.


Secondary Outcome Measures :
  1. The days of mechanical ventilation in intensive care unit [ Time Frame: 30 days after patients recruited in the study ]
    The median length of days of mechanical ventilation needed by the patients in both groups

  2. The days of intensive care unit stay [ Time Frame: 30 days after patients recruited in the study ]
    The median length of days in ICU needed by patients in both groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >= 18 years
  2. Blunt thoracic injury
  3. CT detected hemothorax

Exclusion Criteria:

  1. Hemodynamic instability that is related to HTX in the judgment of the attending clinician
  2. Any scenario where the clinician mandates urgent TT placement
  3. Penetrating thoracic injury
  4. Respiratory distress that is related to HTX in the judgment of the attending clinician
  5. Chest tube already in-situ (eg. Prior to transfer of care to the FMC)
  6. >24 h after admission
  7. Ipsilateral flail chest fracture pattern

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050502


Locations
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Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Chad Ball, MD    403-944-3417    ball.chad@gmail.com   
Foothills Medical Centre, Faculty of Medicine Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Chad G Ball, MD    403-944-3417    ball.chad@gmail.com   
Contact: Jimmy Xiao, PhD    403-944-8750    jimmy.xiao@albertahealthservices.ca   
Principal Investigator: Chad G Ball, MD         
Sub-Investigator: Jimmy Xiao, PhD         
Sponsors and Collaborators
University of Calgary
Alberta Health Services
Investigators
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Principal Investigator: Chad G Ball, MD University of Calgary
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Chad G. Ball, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT03050502    
Other Study ID Numbers: REB16-1056
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Chad G. Ball, University of Calgary:
Hemothorax
Management
Additional relevant MeSH terms:
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Hemothorax
Thoracic Injuries
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes
Wounds and Injuries