Resuscitative endovascular balloon occlusion of the aorta (REBOA) in patients with major trauma and uncontrolled haemorrhagic shock: a systematic review with meta-analysis
World journal of emergency surgery : WJES. 2021;16(1):41
BACKGROUND Multiple studies regarding the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in patients with non-compressible torso injuries and uncontrolled haemorrhagic shock were recently published. To date, the clinical evidence of the efficacy of REBOA is still debated. We aimed to conduct a systematic review assessing the clinical efficacy and safety of REBOA in patients with major trauma and uncontrolled haemorrhagic shock. METHODS We systematically searched MEDLINE (PubMed), EMBASE and CENTRAL up to June 2020. All randomized controlled trials and observational studies that investigated the use of REBOA compared to resuscitative thoracotomy (RT) with/without REBOA or no-REBOA were eligible. We followed the PRISMA and MOOSE guidelines. Two authors independently extracted data and appraised the risk of bias of included studies. Effect sizes were pooled in a meta-analysis using random-effects models. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Primary outcomes were mortality, volume of infused blood components, health-related quality of life, time to haemorrhage control and any adverse effects. Secondary outcomes were improvement in haemodynamic status and failure/success of REBOA technique. RESULTS We included 11 studies (5866 participants) ranging from fair to good quality. REBOA was associated with lower mortality when compared to RT (aOR 0.38; 95% CI 0.20-0.74), whereas no difference was observed when REBOA was compared to no-REBOA (aOR 1.40; 95% CI 0.79-2.46). No significant difference in health-related quality of life between REBOA and RT (p = 0.766). The most commonly reported complications were amputation, haematoma and pseudoaneurysm. Sparse data and heterogeneity of reporting for all other outcomes prevented any estimate. CONCLUSIONS Our findings on overall mortality suggest a positive effect of REBOA among non-compressible torso injuries when compared to RT but no differences compared to no-REBOA. Variability in indications and patient characteristics prevents any conclusion deserving further investigation. REBOA should be promoted in specific training programs in an experimental setting in order to test its effectiveness and a randomized trial should be planned.
Effects of emergency treatment mode of damage-control orthopedics in pelvic fracture complicated with multiple fractures
American journal of translational research. 2021;13(6):6817-6826
OBJECTIVE This study aimed to observe the application effect of emergency treatment mode of damage-control orthopedics (DCO) in pelvic fracture complicated with multiple fractures. METHODS Ninety-four patients with pelvic fracture complicated with multiple fractures in our hospital were recruited and divided into two groups according to the random number table method, with 47 cases in each group. Patients in the control group received traditional methods for emergency treatment (early complete treatment), and patients in the research group received DCO for emergency treatment (treatment performed in stages according to patient's physiological tolerance, with simplified initial surgery, followed by ICU resuscitation, and finally definitive surgery). The two groups were compared in terms of mortality, the incidence of acidosis and hypothermia three days after the first surgery, surgery-related indexes (time of the first surgery, blood transfusion volume, intraoperative blood loss, recovery time of temperature, and length of hospital stay), coagulation function indexes (activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT) and fibrinogen (FIB)), postoperative reduction of fracture, complication rate, and quality of life. RESULTS The incidences of acidosis, hypothermia, and mortality three days after the first surgery in the research group were lower than those in the control group (P<0.05). Compared with the control group, the research group experienced shorter time of the first surgery, less intraoperative blood transfusion volume, less intraoperative blood loss, shorter recovery time of body temperature, and shorter length of hospital stay (P<0.05). Seven days after surgery, PT, TT and APTT decreased and FIB increased in both groups (P<0.05), PT, TT and APTT in the research group were lower than those in the control group (P<0.05), while FIB was higher (P<0.05). The good rate of reduction in the research group was higher than that in the control group (P=0.025). The incidence of complications in the research group was lower than that in the control group (P=0.049). Six months after surgery, the scores of physiological function (PF), body pain (BP), role physical (RP), emotional function (EF), social function (SF), vitality, and general health (GH) of the research group were higher than those of the control group (P<0.05), but there was no significant difference in mental health (MH) between the two groups (P>0.05). CONCLUSION The emergency treatment mode of DCO is effective in pelvic fracture complicated with multiple fractures, which can effectively improve postoperative reduction of patients, improve the coagulation function, reduce complications, and improve the quality of life.
Outcome measures used in clinical research evaluating pre-hospital blood component transfusion in traumatically injured bleeding patients: A systematic review
The journal of trauma and acute care surgery. 2021
BACKGROUND Trial outcomes should be relevant to all stakeholders, and allow assessment of interventions' efficacy and safety at appropriate timeframes. There is no consensus regarding outcome measures in the growing field of pre-hospital trauma transfusion research. Harmonization of future clinical outcome reporting is key to facilitate inter-study comparisons and generate cohesive, robust evidence to guide practice. OBJECTIVES To evaluate outcome measures reported in pre-hospital trauma transfusion trials. METHODS Data Sources, Eligibility Criteria, Participants and InterventionsWe conducted a scoping systematic review to identify the type, number and definitions of outcomes reported in randomised controlled trials, prospective and retrospective observational cohort studies investigating pre-hospital blood component transfusion in adult and paediatric patients with traumatic haemorrhage. Electronic database searching of PubMed, Embase, Web of Science, Cochrane, OVID, clinical trials.gov, and the Transfusion Evidence Library was completed in accordance with PRISMA guidelines.Study Appraisal and Synthesis MethodsTwo review authors independently extracted outcome data. Unique lists of salutogenic (patient-reported health and wellbeing outcomes) and non-salutogenic focused outcomes were established. RESULTS 3,471 records were identified. 34 studies fulfilled inclusion criteria: four military (n = 1,566 patients) and 30 civilian (n = 14,398 patients), all between 2000 and 2020. 212 individual non-patient-reported outcomes were identified, which collapsed into 20 outcome domains with varied definitions and timings. All primary outcomes measured effectiveness, rather than safety or complications. 69% reported mortality, with 11 different definitions. No salutogenic outcomes were reported. LIMITATIONS The review is limited by a lack of high-grade prospective comparative trials with clear predefined primary outcomes. CONCLUSION AND IMPLICATIONS OF KEY FINDINGS There is heterogeneity in outcome reporting and definitions, an absence of patient-reported outcome, and an emphasis on clinical effectiveness rather than safety or adverse events in pre-hospital trauma transfusion trials. We recommend stakeholder consultation and a Delphi process to develop a clearly defined minimum core outcome set for pre-hospital trauma transfusion trials. SYSTEMATIC REVIEW REGISTRATION NUMBER This review was prospectively registered with PROSPERO (CRD42019131406). LEVEL OF EVIDENCE II. STUDY TYPE Scoping Systematic Review.
Adult and paediatric patients with traumatic haemorrhage (34 studies, n= 15,964).
Systematic review to identify the type, number and definitions of outcomes reported in pre-hospital trauma transfusion research.
212 individual non-patient-reported outcomes were identified, which collapsed into 20 outcome domains with varied definitions and timings. All primary outcomes measured effectiveness, rather than safety or complications. 69% reported mortality, with 11 different definitions. No salutogenic outcomes were reported.
Cilostazol administration for subarachnoid hemorrhage: A meta-analysis of randomized controlled trials
Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia. 2021;89:305-310
INTRODUCTION The efficacy of cilostazol administration to treat subarachnoid hemorrhage remains controversial. We conduct a systematic review and meta-analysis to explore the influence of cilostazol administration on treatment efficacy for subarachnoid hemorrhage. METHODS We have searched PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through July 2020 for randomized controlled trials (RCTs) assessing the effect of cilostazol administration in patients with subarachnoid hemorrhage. This meta-analysis is performed using the random-effect model. RESULTS Four RCTs involving 405 patients were included in the meta-analysis. Overall, compared with control group for subarachnoid hemorrhage, cilostazol intervention can significantly reduce symptomatic vasospasm (OR = 0.35; 95% CI = 0.21 to 0.60; P = 0.0001) and cerebral infarction (OR = 0.40; 95% CI = 0.22 to 0.73; P = 0.003), as well as improve no or mild angiographic vasospasm (OR = 2.01; 95% CI = 1.19 to 3.42; P = 0.01) and mRS score ≤ 2 (OR = 2.70; 95% CI = 1.09 to 6.71; P = 0.03), but revealed no obvious influence on severe angiographic vasospasm (OR = 0.53; 95% CI = 0.27 to 1.02; P = 0.06). There were no increase in adverse events (OR = 1.17; 95% CI = 0.54 to 2.52; P = 0.69), hemorrhagic events (OR = 0.62; 95% CI = 0.06 to 6.27; P = 0.69) and cardiac events (OR = 2.14; 95% CI = 0.44 to 10.27; P = 0.34) after the cilostazol intervention than control intervention. CONCLUSIONS Cilostazol treatment may be effective to treat subarachnoid hemorrhage in the terms of symptomatic vasospasm, cerebral infarction, no or mild angiographic vasospasm and mRS score ≤ 2.
Effects of early mobilization on short-term blood pressure variability in acute intracerebral hemorrhage patients: A protocol for randomized controlled non-inferiority trial
BACKGROUND Early out-of-bed mobilization may improve acute post-intracerebral hemorrhage (ICH) outcomes, but hemodynamic instability may be a concern. Some recent studies have showed that an increase in mean systolic blood pressure (SBP) and high blood pressure variability (BPV), high standard deviation of SBP, may lead to negative ICH outcomes. Therefore, we investigated the impact of an early mobilization (EM) protocol on mean SBP and BPV during the acute phase. METHODS The study was an assessor-blinded, randomized controlled non-inferiority study. The participants were in An Early Mobilization for Acute Cerebral Hemorrhage trial and were randomly assigned to undergo EM or a standard early rehabilitation (SER) protocol within 24 to 72 hour after ICH onset at the stroke center. The EM and SER groups each had 30 patients. 24-measurement SBP were recorded on days 2 and 3 after onset, and SBP were recorded three times daily and during rehabilitation on days 4 through 7. The two groups' mean SBP and BPV under three different time frames (days 2 and 3 during the acute phase, and days 4 through 7 during the late acute phase) were calculated and compared. RESULTS At baseline, the two groups' results were similar, with the exception being that the mean time to first out-of-bed mobilization after symptom onset was 51.60 hours (SD 14.15) and 135.02 hours (SD 33.05) for the EM group and SER group, respectively (P < .001). There were no significant differences in mean SBP and BPV during the acute and late acute phase between the two groups for the three analyses (days 2, 3, and 4 through 7) (P > .05). CONCLUSIONS It is safe to implement the EM protocol within 24 to 72 hour of onset for mild-moderate ICH patients during the acute phase.
To Analyze the Role of Intravenous Tranexamic Acid in Hip Fracture surgeries in Orthopedic Trauma
International journal of applied & basic medical research. 2021;11(3):139-142
INTRODUCTION Hip fractures in orthopedic trauma cases are increasing. Majority of such patients undergoing surgery require blood transfusion of one or more units. Intravenous (I. V.) Tranexamic acid (TXA) may decrease loss of blood, decrease need of blood transfusion, and improve postoperative hemoglobin (Hb) along with lesser adverse effects. Risk of thromboembolic phenomena remains a concern. A study was done to analyze the role of I. V. TXA in hip fracture surgeries in trauma cases. MATERIALS AND METHODS Sixty patients were included in the study; in two groups (37 males and 23 females), Group A in which two doses of I. V. TXA 15 mg/kg were given and Group B in which two doses of I. V. placebo were given. RESULTS Total number of randomized hip arthroplasty cases was 22 (11 in Group A and 11 in Group B) whereas randomized osteosynthesis cases were 38 (19 in Group A and 19 in Group B). Mean preoperative Hb value in Group A was 10.8 gm% and in Group B was 10.7 gm% (P > 0.005. Mean postoperative Hb value in Group A was Hb 9.8 gm% and in Group B 9.5 gm% (difference of 3.061%). Mean duration of surgery in Group A was 64.2 min and in Group B was 66.3 min. Mean total blood loss (intraoperative and postoperative) in Group A was 384.6 ml and in Group B was 448.7 ml (14.29% less in Group A). A total of 14 patients in Group A (17 red blood cells [RBCs] units) and 17 patients (21 RBC units) in Group B required RBC transfusion. No major vascular event, severe bacterial infections, symptomatic deep vein thrombosis, pulmonary embolism, limb ischemia, acute coronary syndrome, or immediate postoperative mortality was noted in either group. CONCLUSION I. V. TXA has the potential to decrease risk of blood transfusion, decrease total blood loss, and to maintain a higher postoperative Hb value with no significant adverse reactions. As the number of cases of hip fractures continues to increase along with increase in age, so the use of TXA in such cases may improve clinical outcomes, lessen number of inpatient days and hence decrease overall cost.
A Review of Remote Intracerebral Hemorrhage after Chronic Subdural Hematoma Evacuation
Journal of neurological surgery. Part A, Central European neurosurgery. 2021
BACKGROUND Remote intracerebral hemorrhage (RICH) is a severe complication following chronic subdural hematoma (cSDH) drainage, and only case reports and small case series have been reported to date. The authors present an emblematic patient affected by RICH following cSDH drainage. A systematic review of the literature on diagnosis and management of patients affected by RICH following cSDH evacuation has also been performed. METHODS A literature search according to the PRISMA statement was conducted using PubMed and Scopus databases with the following Mesh terms: [(remote) AND (intracerebral hemorrhage or cerebral hematoma or cerebral infarction or cerebellar hemorrhage or cerebellar hematoma or cerebellar infarction) AND (chronic subdural hematoma)]. RESULTS The literature search yielded 35 results, and 25 articles met our inclusion criteria: 22 articles were case reports and 3 were case series including three to six patients. Overall, 37 patients were included in the study. Age was reported in all 37 patients, 26 males (70.3%) and 11 females (29.7%), with a male-to-female ratio of 2.4:1. The mean age at diagnosis was 64.6 years (range: 0.25-86 years). Only in 5 cases (13.5%) did the ICH occur contralaterally to the previously drained cSDH. The rapidity of drainage can lead to several types of intracranial hemorrhages, caused by a too rapid change in the cerebral blood flow (CBF) and/or tears of bridging veins. The average time interval between cSDH drainage and neurologic deterioration was 71.05 hours (range: 0-192 hours). CONCLUSIONS RICH following cSDH represents a rare occurrence and a serious complication, associated with elevated morbidity. Careful monitoring of drain speed after cSDH evacuation surgery is recommended, and minimally invasive techniques such as twist drill craniostomy are suggested, especially for massive cSDHs.
Prothrombin complex concentrate in major bleeding associated with DOACs; an updated systematic review and meta-analysis
Journal of thrombosis and thrombolysis. 2021
BACKGROUND Four-factor prothrombin complex concentrate (PCC) is frequently used as a reversal agent for major bleeding in patients on factor Xa inhibitors. Piran et al. reviewed its safety and efficacy for the first time in 2018. However, more studies have been published on the matter since then. The aim of this study is to investigate the efficacy and safety of this use and update this review. METHODS We systematically searched in Medline, Scopus, and the Cochrane Library from 1/1/2018 to 6/19/2020. A random effects model meta-analysis of proportions was used to study the efficacy of PCC on major bleeding control, mortality and thrombosis incidence. RESULTS 33 studies (n = 2568 patients), with the majority of studies being uncontrolled retrospective cohort studies, were included; atrial fibrillation was the main factor Xa inhibitors indication and approximately 62% of patients presented with intracranial hemorrhage. We estimated the pooled proportion outcomes for hemostasis (80%, CI 0.75-0.84), mortality (15%, CI 0.11-0.19) and thromboembolic adverse events (3%, CI 0.02-0.05). High versus low dose PCC did not affect hemostasis or thrombosis. Patients with ICH had higher mortality rates (22%, CI 0.13-0.32). Heterogeneity was significant (Ι(2) > 50% with p < 0.05) for all pooled proportional outcomes. The quality of evidence was low given that included studies were not randomized or controlled. CONCLUSION Our study demonstrates the efficacy and safety of the off label use of 4F PCC in major bleeding associated with factor Xa inhibitors. Our data require further validation with future randomized clinical trials.
Mortality benefit of crystalloids administered in 1-6 hours in septic adults in the ED systematic review with narrative synthesis
Emergency medicine journal : EMJ. 2021
BACKGROUND Based on the 2018 update of the Surviving Sepsis Campaign, the Committee for Quality Improvement of the NHSs of England recommended the instigation of the elements of the 'Sepsis-6 bundle' within 1 hour to adult patients screened positive for sepsis. This bundle includes a bolus infusion of 30 mL/kg crystalloids in the ED. Besides the UK, both in the USA and Australia, compliance with similar 1-hour targets became an important quality indicator. However, the supporting evidence may neither be contemporaneous nor necessarily valid for emergency medicine settings. METHOD A systematic review was designed and registered at PROSPERO to assess available emergency medicine/prehospital evidence published between 2012 and 2020, investigating the clinical benefits associated with a bolus infusion of a minimum 30 mL/kg crystalloids within 1 hour to adult patients screened positive for sepsis. Due to the small number of papers that addressed this volume of fluids in 1 hour, we expanded the search to include studies looking at 1-6 hours. RESULTS Seven full-text articles were identified, which investigated various aspects of the fluid resuscitation in adult sepsis. However, none answered completely to the original research question aimed to determine either the effect of time-to-crystalloids or the optimal fluid volume of resuscitation. Our findings demonstrated that in the USA/UK/Australia/Canada, adult ED septic patients receive 23-43 mL/kg of crystalloids during the first 6 hours of resuscitation without significant differences either in mortality or in adverse effects. CONCLUSION This systematic review did not find high-quality evidence supporting the administration of 30 mL/kg crystalloid bolus to adult septic patients within 1 hour of presentation in the ED. Future research must investigate both the benefits and the potential harms of the recommended intervention.
The effect of early vasopressin use on patients with septic shock: A systematic review and meta-analysis
The American journal of emergency medicine. 2021;48:203-208
BACKGROUND The effect of early vasopressin initiation on clinical outcomes in patients with septic shock is uncertain. A systematic review and meta-analysis was performed to evaluate the impact of early start of vasopressin support within 6 h after the diagnosis on clinical outcomes in septic shock patients. METHODS We searched the PubMed, Cochrane, and Embase databases for randomized controlled trials (RCTs) and cohort studies from inception to the 1st of February 2021. We included studies involving adult patients (> 16 years)with septic shock. All authors reported our primary outcome of short-term mortality and in the experimental group patients in the studies receiving vasopressin infusion within 6 h after diagnosis of septic shock and in the control group patients in the studies receiving no vasopressin infusion or vasopressin infusion 6 h after diagnosis of septic shock, clearly comparing with clinically relevant secondary outcomes(use of renal replacement therapy(RRT),new onset arrhythmias, ICU length of stay and length of hospitalization). Results were expressed as odds ratio (OR) and mean difference (MD) with accompanying 95% confidence interval (CI). RESULTS Five studies including 788 patients were included. The primary outcome of this meta-analysis showed that short-term mortality between the two groups was no difference (odds ratio [OR] = 1.09; 95% CI, 0.8 to 1.48; P = 0.6; χ2 = 0.83; I2 = 0%). Secondary outcomes demonstrated that the use of RRT was less in the experimental group than that of the control group (OR = 0.63; 95% CI, 0.44 to 0.88; P = 0.007; χ2 = 3.15; I2 = 36%).The new onset arrhythmias between the two groups was no statistically significant difference (OR = 0.59; 95% CI, 0.31 to 1.1; P = 0.10; χ2 = 4.7; I2 = 36%). There was no statistically significant difference in the ICU length of stay(mean difference = 0.16; 95% CI, - 0.91 to 1.22; P = 0.77; χ2 = 6.08; I2 = 34%) and length of hospitalization (mean difference = -2.41; 95% CI, -6.61 to 1.78; P = 0.26; χ2 = 8.57; I2 = 53%) between the two groups. CONCLUSIONS Early initiation of vasopressin in patients within 6 h of septic shock onset was not associated with decreased short-term mortality, new onset arrhythmias, shorter ICU length of stay and length of hospitalization, but can reduce the use of RRT. Further large-scale RCTs are still needed to evaluate the benefit of starting vasopressin in the early phase of septic shock.