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The Management of Traumatic Hemothoraces (HemoTxRCT)

Primary Purpose

Hemothorax, Thoracic Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Chest tube drain
Expectant management
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemothorax focused on measuring Hemothorax, Management

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foothills Medical CentreRecruiting
  • Foothills Medical Centre, Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Chest tube drain

Expectant management

Arm Description

A chest tube placed with the intent of draining all intra-pleural blood.

No chest tube, but will undergo standard observation/conservative management by the trauma service.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The days of mechanical ventilation in intensive care unit
The median length of days of mechanical ventilation needed by the patients in both groups
The days of intensive care unit stay
The median length of days in ICU needed by patients in both groups

Full Information

First Posted
February 2, 2017
Last Updated
February 1, 2023
Sponsor
University of Calgary
Collaborators
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT03050502
Brief Title
The Management of Traumatic Hemothoraces
Acronym
HemoTxRCT
Official Title
The Management of Traumatic Hemothoraces in Blunt Thoracic Injured Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemothorax, Thoracic Injuries
Keywords
Hemothorax, Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chest tube drain
Arm Type
Active Comparator
Arm Description
A chest tube placed with the intent of draining all intra-pleural blood.
Arm Title
Expectant management
Arm Type
Sham Comparator
Arm Description
No chest tube, but will undergo standard observation/conservative management by the trauma service.
Intervention Type
Device
Intervention Name(s)
Chest tube drain
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Expectant management
Intervention Description
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 Measure Information:
Title
The numbers of hemothoraces that require thoracic interventions.
Description
The rate of hemothoraces that require thoracic interventions in patients of both groups.
Time Frame
1 year after patient recruited in the study
Secondary Outcome Measure Information:
Title
The days of mechanical ventilation in intensive care unit
Description
The median length of days of mechanical ventilation needed by the patients in both groups
Time Frame
30 days after patients recruited in the study
Title
The days of intensive care unit stay
Description
The median length of days in ICU needed by patients in both groups
Time Frame
30 days after patients recruited in the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Blunt thoracic injury CT detected hemothorax Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad G Ball, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Ball, MD
Phone
403-944-3417
Email
ball.chad@gmail.com
Facility Name
Foothills Medical Centre, Faculty of Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad G Ball, MD
Phone
403-944-3417
Email
ball.chad@gmail.com
First Name & Middle Initial & Last Name & Degree
Jimmy Xiao, PhD
Phone
403-944-8750
Email
jimmy.xiao@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Chad G Ball, MD
First Name & Middle Initial & Last Name & Degree
Jimmy Xiao, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17161082
Citation
Stafford RE, Linn J, Washington L. Incidence and management of occult hemothoraces. Am J Surg. 2006 Dec;192(6):722-6. doi: 10.1016/j.amjsurg.2006.08.033.
Results Reference
result
PubMed Identifier
18053373
Citation
Ball CG, Lord J, Laupland KB, Gmora S, Mulloy RH, Ng AK, Schieman C, Kirkpatrick AW. Chest tube complications: how well are we training our residents? Can J Surg. 2007 Dec;50(6):450-8.
Results Reference
result
PubMed Identifier
22929504
Citation
DuBose J, Inaba K, Okoye O, Demetriades D, Scalea T, O'Connor J, Menaker J, Morales C, Shiflett T, Brown C, Copwood B; AAST Retained Hemothorax Study Group. Development of posttraumatic empyema in patients with retained hemothorax: results of a prospective, observational AAST study. J Trauma Acute Care Surg. 2012 Sep;73(3):752-7. doi: 10.1097/TA.0b013e31825c1616.
Results Reference
result
PubMed Identifier
23433600
Citation
Bradley M, Okoye O, DuBose J, Inaba K, Demetriades D, Scalea T, O'Connor J, Menaker J, Morales C, Shiflett T, Brown C. Risk factors for post-traumatic pneumonia in patients with retained haemothorax: results of a prospective, observational AAST study. Injury. 2013 Sep;44(9):1159-64. doi: 10.1016/j.injury.2013.01.032. Epub 2013 Feb 19.
Results Reference
result
PubMed Identifier
22310111
Citation
DuBose J, Inaba K, Demetriades D, Scalea TM, O'Connor J, Menaker J, Morales C, Konstantinidis A, Shiflett A, Copwood B; AAST Retained Hemothorax Study Group. Management of post-traumatic retained hemothorax: a prospective, observational, multicenter AAST study. J Trauma Acute Care Surg. 2012 Jan;72(1):11-22; discussion 22-4; quiz 316. doi: 10.1097/TA.0b013e318242e368.
Results Reference
result
PubMed Identifier
21307755
Citation
Mowery NT, Gunter OL, Collier BR, Diaz JJ Jr, Haut E, Hildreth A, Holevar M, Mayberry J, Streib E. Practice management guidelines for management of hemothorax and occult pneumothorax. J Trauma. 2011 Feb;70(2):510-8. doi: 10.1097/TA.0b013e31820b5c31. No abstract available.
Results Reference
result
PubMed Identifier
17650692
Citation
Khandhar SJ, Johnson SB, Calhoon JH. Overview of thoracic trauma in the United States. Thorac Surg Clin. 2007 Feb;17(1):1-9. doi: 10.1016/j.thorsurg.2007.02.004.
Results Reference
result
PubMed Identifier
15454805
Citation
Kulshrestha P, Munshi I, Wait R. Profile of chest trauma in a level I trauma center. J Trauma. 2004 Sep;57(3):576-81. doi: 10.1097/01.ta.0000091107.00699.c7.
Results Reference
result
PubMed Identifier
16307931
Citation
Bilello JF, Davis JW, Lemaster DM. Occult traumatic hemothorax: when can sleeping dogs lie? Am J Surg. 2005 Dec;190(6):841-4. doi: 10.1016/j.amjsurg.2005.05.053.
Results Reference
result
PubMed Identifier
25983221
Citation
Wells BJ, Roberts DJ, Grondin S, Navsaria PH, Kirkpatrick AW, Dunham MB, Ball CG. To drain or not to drain? Predictors of tube thoracostomy insertion and outcomes associated with drainage of traumatic hemothoraces. Injury. 2015 Sep;46(9):1743-8. doi: 10.1016/j.injury.2015.04.032. Epub 2015 May 7.
Results Reference
result
PubMed Identifier
29502092
Citation
Carver DA, Bressan AK, Schieman C, Grondin SC, Kirkpatrick AW, Lall R, McBeth PB, Dunham MB, Ball CG. Management of haemothoraces in blunt thoracic trauma: study protocol for a randomised controlled trial. BMJ Open. 2018 Mar 3;8(3):e020378. doi: 10.1136/bmjopen-2017-020378.
Results Reference
derived

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The Management of Traumatic Hemothoraces

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