Recruiting

Traumatic Hemothoraces

Sponsor:

University of Calgary

Code:

NCT03050502

Conditions

Hemothorax

Thoracic Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Chest tube drain

Expectant management

Study Details

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

Study ID

NCT03050502

Start date

Feb 1, 2018

Status verified date

Feb, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Chest tube drain

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

sham comparator: Expectant management

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

Interventions

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.

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 measure

  • The numbers of hemothoraces that require thoracic interventions. [ Time Frame: 1 year after patient recruited in the study ]

Central Contacts and Locations

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Foothills Medical Centre, Faculty of Medicine

Recruiting

Calgary, Alberta, Canada, T2N2T9

Contacts

Principal Investigator:

Chad G Ball, MD

More Information

Sponsor

University of Calgary

Last update posted

Feb 3, 2023

Last verified

Feb, 2023

Keywords

  • Hemothorax
  • Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2023-02-03.