react 2 trial
TRANSCRIPT
REACT 2 Trial: “pan scan" vs "selective scan" in traumaClaire Plint CME 11/08/2016
Background
▪ Pan scans common practice in trauma centers▪ CT – accurate with low missed diagnosis rate▪ Huber-Wagner et al Effect of whole-body CT during
trauma resuscitation on survival: a retrospective, multicentre study - Total-body CT decreased mortality by 25%
Absence of level 1 Evidence in using total-body CT (TBCT) scan or “pan scan” in Trauma
REACT - 2
▪ International, multicentre, randomised controlled trial▪ Compared immediate TBCT scanning with a standard
work-up with conventional imaging supplemented by selective CT scanning in patients with severe trauma
▪ Does TBCT reduce hospital mortality in severe trauma?
Study Design
▪ Took place at 4 hospitals in the Netherlands and 1 in Switzerland– level 1 trauma centres and academic teaching hospitals
▪ Trauma patients 18 years and older with:– compromised vital parameters– clinical suspicion of life-threatening injuries– severe injury
▪ Randomly assigned to immediate total-body CT scanning or to a standard work-up with conventional imaging supplemented with selective CT scanning
Study Design continued
▪ Neither doctors nor patients were masked to treatment allocation
▪ The primary endpoint was in-hospital mortality, analysed in the intention-to-treat population
▪ Subgroups of patients with polytrauma and those with traumatic brain injury.
Inclusion CriteriaTrauma patients with the presence of life-threatening vital problems defined as at least one of the following
Patients with one of the following clinically suspicious diagnoses:
Patients with one of the following injury mechanisms:
• RR ≥ 30 min of ≤ 10/min
• HR ≥ 120/min
• SBP ≤ 100 mmHg
• estimated exterior blood loss ≥ 500 ml
• GCS ≤ 13
• Abnormal pupillary reaction onsite
• flail chest, open chest or multiple rib fractures
• severe abdominal injury
• pelvic fracture
• unstable vertebral fractures/spinal cord compression
• fractures from at least two long bones
• fall from height (> 3 m)
• ejection from the vehicle
• death occupant in same vehicle
• severely injured patient in same vehicle
• wedged or trapped chest/abdomen
Exclusion Criteria
▪ known age < 18 years▪ known pregnancy▪ referred from another hospital▪ clearly low-energy trauma with blunt injury mechanism▪ penetrating injury in 1 body region (except gun shot wounds) as
the clearly isolated injury▪ any patient who is judged to be too unstable to undergo a CT
scan and requires (cardiopulmonary) resuscitation or immediate operation because death is imminent according to the trauma team leader in mutual agreement with the other leading care givers
Outcomes
▪ The primary endpoint was in-hospital mortality▪ Secondary endpoints were:– 24-h mortality– 30-day mortality– clinically relevant time intervals during the trauma survey– duration of stay– number of ventilation days for patients admitted to ICU– readmission within 6 months– radiation exposure– complications– number of patients who received at least one blood transfusion – hospital costs
Statistical Analysis
▪ 539 patients in each group would give the study an 80% power to detect an absolute risk reduction of 5% with a false positive rate of 5%
▪ The statistical analyses were done by the study investigators and independently by a clinical epidemiologist not involved in the trial
Randomisation
▪ Study began April 22, 2011, and ended on Jan 1, 2014▪ 5475 patients were assessed for eligibility▪ 1403 patients were randomly assigned: – 702 to total-body CT scanning– 701 to standard work-up– 203 patients were excluded after random allocation
▪ 541 patients in the TBCT scan group ▪ 542 in the standard work-up group
Included in Primary analysis
INTERVENTION GROUP▪ Immediate total-body CT
scanning (vertex to pubic symphysis)– Without prior conventional
imaging– Potential life saving
interventions performed prior to imaging including: intubation, chest tube insertion, pericardiocentesis, haemorrhage control
CONTROL GROUP▪ Selective CT scanning– Chest and pelvic x-ray and
FAST scan performed during primary survey
– Selective CT scanning. Indications were pre-defined according to local protocols
Group Comparisons
No significant difference in:▪ Age (median): 42 vs. 45▪ % that received blood transfusion: 27% vs. 28%▪ Blunt trauma: 98% vs. 98.3%▪ Traumatic brain injury: 32.9% vs. 27.9%
The groups were comparable for all characteristics except for:
▪ Number of patients with polytrauma– TBCT 362 [67%] of 541 vs standard work-up 331 [61%] of 542
▪ Median haemoglobin concentration– 129 g/L [IQR 113–142] vs 133 g/L [120–145]
▪ Median haematocrit concentration – 38 L/L [IQR 34–41] vs 39 L/L [35–42]
▪ Median ISS did not differ between groups– TBCT 20 [IQR 10–29] vs standard work-up 19 [9–29]
HOWEVER
Significantly more patients with ISS≥16– 67% vs. 61%, p=0.045
Results
▪ No significant difference in in-hospital mortality between groups – 86 [16%] of 541 in the TBCT group vs 85 [16%] of 542
in the standard work-up group; p=0·92
▪ Mortality also did not differ between groups in subgroup analyses of patients with polytrauma and TBI
Results continued
Median radiation exposure in the trauma room:– higher in patients in the TBCT group than in those in the
standard work-up group 20·9 mSv, IQR 20·6–20·9 vs 20·6 mSv, 9·9–22·1; p<0·0001
– higher in the TBCT group during total hospital admission 21·0 mSv [20·9–25·2] vs 20·6 mSv [11·8–27·6]; p<0·0001
In the standard work-up group:▪ more patients were exposed to a lower radiation dose
– 45% patients had a radiation dose that was lower than the lowest dose of 20 mSv in patients who underwent a TBCT scan
▪ 250 (46%) of 542 patients underwent sequential segmental CT scans of all body regions, comprising a TBCT scan in the end
Results continued...
▪ Median time to end of imaging was decreased in patients in the TBCT group compared with the standard work-up group – 30 min [IQR 24–40] vs 37 min [28–52]; p<0·0001
▪ Time to diagnosis also reduced in TBCT– 50 min [38–68] vs 58 min [42–78]; p=0·001
Results – No significant Difference
▪ Time spent in the trauma room – 63min vs. 72 min, p=0.067
▪ Direct medical costs – 24,967 EUROS vs. 26,995 EUROS, p=0.439
▪ Number of missed injuries found during tertiary survey – 8.8% vs. 10.1%, p=0.45
▪ Life threatening event during scanning– 0.6% vs. 0.2%, p=0.374
Points for discussion:
▪ No consensus exists regarding the appropriate selection criteria for patients eligible for a total-body CT scan
▪ Lower total radiation dose in standard workup group as 36% of patients in this group did not have polytrauma
▪ 46% of standard workup ended up having TBCT - ?causing bias in results
▪ Unmasked randomisation process▪ Differences in baseline characteristics with more patients in
the intervention group having an ISS score of ≥16 - – may just be that the whole body CT scan diagnosed more injuries and
therefore these patients had a higher ISS score
References/resources
▪ Sierink, Joanne C et al. Immediate total-body CT scanning versus conventional imaging and selective CT scanning in patients with severe trauma (REACT-2): a randomised controlled trial. Lancet June 28th 2016
▪ Huber-Wagner et al. Effect of whole-body CT during trauma resuscitation on survival: a retrospective, multicentre study. Lancet 2009 Apr 25;373(9673):1455-61
▪ Total-body CT scanning in trauma patients Benefits and boundaries. Joanne Sierink. http://www.trauma.nl/sites/www.trauma.nl/files/proefschriften/JoanneSierink-proefschrift.pdf#page=131
▪ Xray Risk Calculator - http://www.xrayrisk.com/calculator/calculator-normal-studies.php
FOAM:▪ The Bottom Line. http://www.thebottomline.org.uk/summaries/em/react-2/▪ St Emlyn’s Blog. http://stemlynsblog.org/jc-always-need-whole-body-ct-trauma-st-emlyns/▪ EMCrit. http://emcrit.org/emnerd/case-anatomic-injury-part-ii/ ▪ LITFL. http://lifeinthefastlane.com/imaging-in-trauma/