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REACT 2 Trial: “pan scan" vs "selective scan" in trauma Claire Plint CME 11/08/2016

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REACT 2 Trial: “pan scan" vs "selective scan" in traumaClaire Plint CME 11/08/2016

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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

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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?

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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

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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. 

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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

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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

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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

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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

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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

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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

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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%

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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

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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 

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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

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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

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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

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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

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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/