Targeted prophylactic anticoagulation based on the TRiP(cast) score in patients with lower limb immobilisation: a multicentre, stepped wedge, randomised implementation trial.

BACKGROUND: Prophylactic anticoagulation in emergency department patients with lower limb trauma requiring immobilisation is controversial. The Thrombosis Risk Prediction for Patients with Cast Immobilisation-TRiP(cast)-score could identify a large subgroup of patients at low risk of venous thromboembolism for whom prophylactic anticoagulation can be safely withheld. We aimed to prospectively assess the safety of withholding anticoagulation for patients with lower limb trauma at low risk of venous thromboembolism, defined by a TRiP(cast) score of less than 7. METHODS: CASTING was a stepped-wedge, multicentre, cluster-randomised trial with blinded outcome assessment. 15 emergency departments in France and Belgium were selected and randomly assigned staggered start dates for switching from the control phase (ie, anticoagulation prescription according to the physician's usual practice) to the intervention phase (ie, targeted anticoagulation according to TRiP(cast) score: no prescription if score <7 and anticoagulation if score was ≥7). Patients were included if they presented to a participating emergency department with lower limb trauma requiring immobilisation for at least 7 days and were aged 18 years or older. The primary outcome was the 3-month cumulative rate of symptomatic venous thromboembolism during the intervention phase in patients with a TRiP(cast) score of less than 7. The targeted strategy was considered safe if this rate was less than 1% with an upper 95% CI of less than 2%. The primary analysis was performed in the intention-to-treat population. This study is registered at ClinicalTrials.gov (NCT04064489). FINDINGS: Between June 16, 2020, and Sept 15, 2021, 15 clusters and 2120 patients were included. Of the 1505 patients analysed in the intervention phase, 1159 (77·0%) had a TRiP(cast) score of less than 7 and did not receive anticoagulant treatment. The symptomatic venous thromboembolism rate was 0·7% (95% CI 0·3-1·4, n=8/1159). There was no difference between the control and the intervention phases in the cumulative rate of symptomatic venous thromboembolism or in bleeding rates. INTERPRETATION: Patients with a TRiP(cast) score of less than 7 who are not receiving anticoagulation have a very low risk of venous thromboembolism. A large proportion of patients with lower limb trauma and immobilisation could safely avoid thromboprophylaxis. FUNDING: French Ministry of Health.

Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study.

BACKGROUND: Intravenous morphine (IVM) is the most common strong analgesic used in trauma, but is associated with a clear time limitation related to the need to obtain an access route. The intranasal (IN) route provides easy administration with a fast peak action time due to high vascularization and the absence of first-pass metabolism. We aimed to determine whether IN sufentanil (INS) for patients presenting to an emergency department with acute severe traumatic pain results in a reduction in pain intensity non-inferior to IVM. METHODS AND FINDINGS: In a prospective, randomized, multicenter non-inferiority trial conducted in the emergency departments of 6 hospitals across France, patients were randomized 1:1 to INS titration (0.3 µg/kg and additional doses of 0.15 µg/kg at 10 minutes and 20 minutes if numerical pain rating scale [NRS] > 3) and intravenous placebo, or to IVM (0.1 mg/kg and additional doses of 0.05 mg/kg at 10 minutes and 20 minutes if NRS > 3) and IN placebo. Patients, clinical staff, and research staff were blinded to the treatment allocation. The primary endpoint was the total decrease on NRS at 30 minutes after first administration. The prespecified non-inferiority margin was -1.3 on the NRS. The primary outcome was analyzed per protocol. Adverse events were prospectively recorded during 4 hours. Among the 194 patients enrolled in the emergency department cohort between November 4, 2013, and April 10, 2016, 157 were randomized, and the protocol was correctly administered in 136 (69 IVM group, 67 INS group, per protocol population, 76% men, median age 40 [IQR 29 to 54] years). The mean difference between NRS at first administration and NRS at 30 minutes was -4.1 (97.5% CI -4.6 to -3.6) in the IVM group and -5.2 (97.5% CI -5.7 to -4.6) in the INS group. Non-inferiority was demonstrated (p < 0.001 with 1-sided mean-equivalence t test), as the lower 97.5% confidence interval of 0.29 (97.5% CI 0.29 to 1.93) was above the prespecified margin of -1.3. INS was superior to IVM (intention to treat analysis: p = 0.034), but without a clinically significant difference in mean NRS between groups. Six severe adverse events were observed in the INS group and 2 in the IVM group (number needed to harm: 17), including an apparent imbalance for hypoxemia (3 in the INS group versus 1 in the IVM group) and for bradypnea (2 in the INS group versus 0 in the IVM group). The main limitation of the study was that the choice of concomitant analgesics, when they were used, was left to the discretion of the physician in charge, and co-analgesia was more often used in the IVM group. Moreover, the size of the study did not allow us to conclude with certainty about the safety of INS in emergency settings. CONCLUSIONS: We confirm the non-inferiority of INS compared to IVM for pain reduction at 30 minutes after administration in patients with severe traumatic pain presenting to an emergency department. The IN route, with no need to obtain a venous route, may allow early and effective analgesia in emergency settings and in difficult situations. Confirmation of the safety profile of INS will require further larger studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02095366. EudraCT 2013-001665-16.

Computer-assisted navigation in ACL reconstruction is attractive but not yet cost efficient.

PURPOSE: Conventional reconstruction of the anterior cruciate ligament (ACL) has a high success rate. Computer-assisted navigation systems (CANSs) have been developed to further improve the accuracy of tunnel positioning. What is the economic impact from the hospital perspective? METHODS: Patients having a first ACL reconstruction procedure were included in a prospective multicentre open controlled study comparing two groups: CANS versus conventional surgery. The primary clinical efficacy criterion was the objective International Knee Documentation Committee score at 1-2-year follow-up. Costs were collected retrospectively nationwide. RESULTS: No significant differences were found for the clinical effectiveness between conventional surgery (100 patients) and CANS (114 patients) at follow-up: ORadjusted 1.01 [0.36-2.84] (n.s). Junior surgeons achieved a significant mean decrease in operating time during the study period: 30 % in the CANS group compared with 10 % in the control group (p < 0.01). The average cost of surgery was 704 for the control group and 1,158 for the CANS group (p < 0.01). The cost of the operating room accounts for >70 % of the total cost. The surgeon's status and the technical CANS learning effect influenced this cost. The cost differential between the two groups decreased with 'CANS' expertise: 238 and 271 in 'expert' centres versus 427 to 731 in other centres. CONCLUSION: While our study demonstrates the feasibility and the potential interest of CANS for training in ACL reconstruction, from a hospital perspective it is not cost efficient at present. LEVEL OF EVIDENCE: Economic and decision analysis-developing an economic or decision model, Level II.

Deciphering acute shoulder trauma with normal initial X-ray: Contributions of ultrasonography and MRI.

INTRODUCTION: Shoulder trauma with normal radiographs is a frequent emergency presentation. The predominance of pain makes clinical examination unreliable, and complementary imaging is often needed for diagnosis. The aim of the present study was to assess the contribution of ultrasonography (US) and magnetic resonance imaging (MRI) in deciphering such trauma. The study hypothesis was that MRI can confirm most diagnoses and reveal occult lesions. METHODS: 48 patients with a median age of 33 years (IQR, 22-48.75), admitted to the Emergency Department between February and September 2016, were prospectively included. All had normal X-ray and underwent emergency and deferred emergency (D+7-10) clinical examination, and US and MRI at D+7-14. The same examinations were repeated to establish diagnosis and initiate treatment. MRI was considered as gold-standard for definite diagnosis. RESULTS: Diagnoses comprised: 14 shoulder contusions; 13 rotator cuff tears; 8 acromioclavicular sprains; 6 fractures: 3 greater tuberosity, 2 humeral head, 1 lateral quarter of the clavicle; 3 subluxations or anterior dislocations with spontaneous reduction; 1 posterior dislocation with spontaneous reduction; 1 case of resorption of calcification in the pectoralis major tendon; 1 case of coracobrachialis strain; and 1 partial pectoralis major detachment. Concordance with final diagnosis was 42% (20/48) on initial clinical examination and 52% (25/48) on reassessment. On US, concordance was 71% (34/48), with 82% positive predictive value for cuff tear and 0% for instability. MRI was contributive in all cases, revealing 48 abnormal signals in 41 patients, thus establishing 48 diagnoses. CONCLUSION: Except in precise diagnostic situations such as rotator cuff tear, US is not a contributive examination, completely overlooking shoulder instability and bone contusion. MRI should play an increasing role in deciphering these traumas. LEVEL OF EVIDENCE: II; prospective cohort study.