The Management of Traumatic Hemothoraces

NCT03050502 | Unknown

• 1 other identifier: REB16-1056
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemothorax; Thoracic Injuries

Keywords

Hemothorax; Management

Outcome Measures

Primary Outcomes (1)

• The numbers of hemothoraces that require thoracic interventions.

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

  1 year after patient recruited in the study

Secondary Outcomes (2)

• The days of mechanical ventilation in intensive care unit

  30 days after patients recruited in the study

• The days of intensive care unit stay

  30 days after patients recruited in the study

Study Arms (2)

Chest tube drain

ACTIVE COMPARATOR

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

Device: Chest tube drain

Expectant management

SHAM COMPARATOR

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

Other: Expectant management

Interventions

Chest tube drain DEVICE

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.

Chest tube drain

Expectant management OTHER

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.

Expectant management

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Foothills Medical Centre, Faculty of Medicine

Calgary, Alberta, T2N2T9, Canada

RECRUITING

Related Publications (11)

• 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.

  PMID: 17161082 RESULT

• 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.

  PMID: 18053373 RESULT

• 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.

  PMID: 22929504 RESULT

• 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.

  PMID: 23433600 RESULT

• 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.

  PMID: 22310111 RESULT

• 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.

  PMID: 21307755 RESULT

• 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.

  PMID: 17650692 RESULT

• 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.

  PMID: 15454805 RESULT

• 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.

  PMID: 16307931 RESULT

• 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.

  PMID: 25983221 RESULT

• 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.

  PMID: 29502092 DERIVED

MeSH Terms

Conditions

Hemothorax; Thoracic Injuries

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Chad G Ball, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 13, 2017
• Study Start: February 1, 2018
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)