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Management of Haemothoraces in Blunt Thoracic Trauma: Study Protocol for a Randomised Controlled Trial

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Management of Haemothoraces in Blunt Thoracic Trauma: Study Protocol for a Randomised Controlled Trial Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2017-020378 on 3 March 2018. Downloaded from Management of haemothoraces in blunt thoracic trauma: study protocol for a randomised controlled trial David A Carver,1,2 Alexsander K Bressan,1,2 Colin Schieman,1,2 Sean C Grondin,1,2 Andrew W Kirkpatrick,1,2 Rohan Lall,1,2 Paul B McBeth,1,2 Michael B Dunham,1,2 Chad G Ball1,2 To cite: Carver DA, Bressan AK, ABSTRACT Strengths and limitations of this study Schieman C, et al. Management Introduction Haemothorax following blunt thoracic of haemothoraces in blunt trauma is a common source of morbidity and mortality. The ► First randomised controlled trial designed to clarify thoracic trauma: study optimal management of moderate to large haemothoraces protocol for a randomised the role of chest drainage for blunt traumatic has yet to be defined. Observational data have suggested controlled trial. BMJ Open haemothorax. that expectant management may be an appropriate 2018;8:e020378. doi:10.1136/ ► The nature of the intervention groups does not allow strategy in stable patients. This study aims to compare bmjopen-2017-020378 for blinding. the outcomes of patients with haemothoraces following ► This is a single-centre study. ► Prepublication history for blunt thoracic trauma treated with either chest drainage or this paper is available online. expectant management. To view these files, please visit Methods and analysis This is a single-centre, dual-arm the journal online (http:// dx. doi. Prior to the ubiquitous use of chest CT, diag- org/ 10. 1136/ bmjopen- 2017- randomised controlled trial. Patients presenting with a 020378 ) moderate to large sized haemothorax following blunt nosing quantities of blood <1000 mL was chal- thoracic trauma will be assessed for eligibility. Eligible lenging. With the widespread adoption of CT Received 31 October 2017 patients will then undergo an informed consent process ‘pan-scanning’, however, significantly more Revised 12 January 2018 followed by randomisation to either (1) chest drainage HTXs are being detected. The clinical signifi- Accepted 15 January 2018 (tube thoracostomy) or (2) expectant management. These cance and optimal treatment of these small to groups will be compared for the rate of additional thoracic moderate HTXs remain unknown.6 interventions, major thoracic complications, length of stay The East American Association of Trauma http://bmjopen.bmj.com/ and mortality. guidelines suggest that all HTXs should be Ethics and dissemination This study has been approved 7 by the institution’s research ethics board and registered considered for TT drainage. However, several with ClinicalTrials. gov. All eligible participants will provide retrospective studies suggest that many trau- informed consent prior to randomisation. The results of matic HTXs can be managed expectantly 8–12 this study may provide guidance in an area where there without TT drainage. A prospective observa- remains significant variation between clinicians. The results tional study also suggests that small to moderate of this study will be published in peer-reviewed journals and HTXs (<300 cc of blood) can be absorbed 5 presented at national and international conferences. without intervention. Classic studies from on September 23, 2021 by guest. Protected copyright. Trial registration number NCT03050502. the 1960s indicate that much larger quantities of blood can be reabsorbed without interven- tion as well.13 14 As a result, the management of HTXs remains a clinical dilemma when the INTRODUCTIon volume of blood is moderate to large and the Thoracic injuries are common in patients patient is haemodynamically stable. with blunt polytrauma and are responsible for This study aims to evaluate the rate of addi- approximately 25% of all injury-related mortal- tional thoracic interventions after expectant 1 ities. Traumatic injuries to the thorax often management as compared with upfront pleural result in the accumulation of blood within the drainage in patients with moderate to large pleural space (ie, a haemothorax (HTX)). 1Department of Surgery, volume haemothoraces secondary to blunt University of Calgary, Calgary, Traditionally, the management of HTXs has trauma. Alberta, Canada included chest tube placement. Although HTXs 2Foothills Medical Centre, are effectively managed with tube thoracos- Calgary, Alberta, Canada tomy (TT), this intervention is associated with METHODS AND ANALYSIS Correspondence to a number of potentially serious complications Overview Dr Chad G Ball; including iatrogenic injury, retained HTXs and The study will be a single-centre, dual-arm, Ball. Chad@ gmail. com empyema in up to 22% of patients.2–5 parallel randomised controlled trial. Patients Carver DA, et al. BMJ Open 2018;8:e020378. doi:10.1136/bmjopen-2017-020378 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-020378 on 3 March 2018. Downloaded from Figure 1 SPIRIT diagram describing schedule of enrolment, interventions and assessments. SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials. presenting with HTXs secondary to blunt thoracic trauma Alberta, Southwest Saskatchewan and Southwest British that are moderate to large in size will be randomised in Columbia. http://bmjopen.bmj.com/ a 1:1 ratio to chest drainage or expectant management. We hypothesise non-inferiority of expectant management Eligibility criteria as compared with pleural drainage in terms of rate of The population will consist of all eligible patients additional thoracic interventions. This study protocol was presenting with moderate to large sized HTXs (≥300 cc, constructed in accordance with the Standard Protocol as estimated on CT) secondary to blunt thoracic trauma. Items: Recommendations for Interventional Trials HTX size will be evaluated using a previously validated 2 (SPIRIT) 2013 guidelines.15 A SPIRIT diagram detailing formula: V=d ×X×L, where V is volume of blood in cubic the timing of screening, randomisation, allocation and centimetres (cc), d is the greatest depth of HTX from on September 23, 2021 by guest. Protected copyright. assessment is provided in figure 1. the chest wall to lung on any CT image in centimetres, X is the thickness of CT slice in centimetres and L is the total Trial design craniocaudal length occupied by pleural fluid in centime- HTXs are common among patients with blunt thoracic tres.5 17 HTX size will be calculated by both a trauma team trauma. They are associated with a range of intrathoracic leader and an attending radiologist. The inclusion and and extrathoracic injuries with varying severity. The trial exclusion criteria are designed to identify a population described below incorporates this real-world variability of patients presenting with blunt traumatic HTXs who do and therefore adopts a pragmatic trial design. The explan- not have an urgent clinical indication for TT. These are atory versus pragmatic nature of the trial is summarised summarised in table 1. visually using the pragmatic explanatory continuum indi- cator summary (PRECIS-2) wheel (figure 2).16 Consent Eligibility will be determined by the attending trauma Setting surgeon at the time of initial admission investigations. The study will take place at the Foothills Medical Centre Informed consent and randomisation will also occur as (FMC), a University of Calgary affiliated tertiary care soon as possible within a 24-hour window from admission hospital located in Calgary, Alberta, Canada. The FMC is (figure 1). This 24-hour window will begin at the time a Trauma Association of Canada (TAC) accredited level of admission to our institution in an effort to include 1 trauma centre that provides trauma care to southern eligible patients transferred from other regional centres. 2 Carver DA, et al. BMJ Open 2018;8:e020378. doi:10.1136/bmjopen-2017-020378 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-020378 on 3 March 2018. Downloaded from Figure 2 Description of trial design using pragmatic explanatory continuum indicator summary wheel. The intervention will be applied immediately following for only one side. The intervention will then be applied randomisation. to both sides. Randomisation http://bmjopen.bmj.com/ Interventions Once eligibility has been determined, participants will be 1. Chest drainage: this group will have an intrapleural randomised using a block randomisation model (block catheter placed with the intent of draining all in- size 4). The randomisation tool is located on a pass- trapleural blood (HTX). The size and nature of the word-protected website. If an eligible patient has bilateral catheter, manner of placement and timing of removal blunt traumatic haemothoraces, randomisation will occur will be at the discretion of the attending trauma team leader. 2. Observation (expectant management): this group on September 23, 2021 by guest. Protected copyright. Table 1 Eligibility criteria will not have an intrapleural catheter placed on the Inclusion criteria Exclusion criteria basis of the HTX, but will undergo standard observa- Age≥18 years Haemodynamic instability tion/conservative management by the trauma service. attributed to HTX* Intrapleural catheters may be placed after enrolment Blunt thoracic injury Respiratory distress attributed at the attending clinician’s discretion. After enrol- to HTX* ment, this decision will constitute an outcome variable Moderate or large Any scenario requiring urgent and require full documentation as to the indications HTX (≥300 cc) detected on TT placement* and
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