Is fresh, leucodepleted, whole blood transfusion superior to blood component transfusion in pediatric patients undergoing spinal deformity surgeries? A prospective, randomized study analyzing postoperative serological parameters and clinical recovery
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2021;:1-7
PURPOSE To compare the effectiveness of fresh whole blood (FWB) and blood component transfusion in improving clinical outcome and serological parameters in the early postoperative period following spinal deformity surgery. METHODS Patients undergoing major spinal deformity surgeries involving ≥ 6 levels of fusion and expected blood loss ≥ 750 ml between September 2017 and August 2018 were included in the study. The patients were randomized into two groups: FWBG and CG, receiving fresh whole blood and component transfusions, respectively. RESULTS A total of 65 patients with spinal deformities of different etiologies were included. The mean age was 14.0 and 14.9 years in FWB and CG, respectively. All other preoperative parameters were comparable. The mean fusion levels and surgical time were 11.1 and 221.20 min in FWB, as compared with 10.70 and 208.74minutes in CG, respectively. Intraoperative blood losses were 929 ml (FWBG) and 847 ml(CG), and the mean volumes of transfusion were 1.90 (FWBG) and 1.65 units (CG). FWBG was significantly superior to CG in the following clinical and laboratory parameters: duration of oxygen dependence [36.43 (FWBG) vs. 43.45 h (CG); P = 0.0256], mean arterial pH [7.442 (FWBG) vs. 7.394 (CG); p < 0.001], interleukin-6 [30.04 (FWBG) vs. 35.10 (CG); p < 0.019], mean duration of HDU stay [40.6 hours (FWBG) vs 46.51 hours (CG); p = 0.0234] and postoperative facial puffiness [7/30 in FWBG vs. 18/35 (CG) (P < 0.02)]. CONCLUSION FWB transfusion can potentially improve the immediate postoperative outcome in patients undergoing major spinal deformity surgeries by reducing the duration of intensive care unit stay and oxygen dependence. The other potential benefits of this practice, based on our study, include a reduced inflammatory response (reduced lactate and IL-6) and postoperative facial puffiness. However, further large-scale validation studies in future are necessary to precisely determine the role of FWB in spine surgeries. LEVEL OF EVIDENCE II Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.
Paediatric patients undergoing spinal deformity surgery (n= 65).
Fresh whole blood: FWBG group (n= 30).
Component transfusions: CG group (n = 35).
The mean fusion levels and surgical time were 11.1 and 221.20 min in FWB, as compared with 10.70 and 208.74 minutes in CG, respectively. Intraoperative blood losses were 929 ml (FWBG) and 847 ml (CG), and the mean volumes of transfusion were 1.90 (FWBG) and 1.65 units (CG). FWBG was significantly superior to CG in the following clinical and laboratory parameters: duration of oxygen dependence, mean arterial pH, interleukin-6, mean duration of high dependency unit stay and postoperative facial puffiness.
Intraoperative tranexamic acid use in patients undergoing excision of intracranial meningioma: Randomized, placebo-controlled trial
Surgical neurology international. 2021;12:289
BACKGROUND Intracranial meningioma resection is associated with substantial intraoperative bleeding. Intraoperative tranexamic acid (TXA) use can reduce bleeding in a variety of surgical procedures. The objective of this study was to evaluate the effects of TXA treatment on blood loss and transfusion requirements in patient undergoing resection of intracranial meningioma. METHODS We conducted a prospective, randomized double-blind clinical study. The patient scheduled to undergo excision of intracranial meningioma were randomly assigned to receive intraoperatively either intravenous TXA or placebo. Patients in the TXA group received intravenous bolus of 20 mg/kg over 20 min followed by an infusion of 1 mg/kg/h up to surgical wound closure. Efficacy was evaluated based on total blood loss and transfusion requirements. Postoperatively, thrombotic complications, convulsive seizure, and hematoma formation were noted. RESULTS Ninety-one patients were enrolled and randomized: 45 received TXA (TXA group) and 46 received placebo (group placebo). Total blood loss was significantly decreased in TXA group compared to placebo (283 ml vs. 576 ml; P < 0.001). Transfusion requirements were comparable in the two groups (P = 0.95). The incidence of thrombotic complications, convulsive seizure, and hematoma formation was similar in the two groups. CONCLUSION TXA significantly reduces intraoperative blood loss, but did not significantly reduced transfusion requirements in adults undergoing resection of intracranial meningioma.
Ultrasonic Bone Scalpel (USBS) Does Not Reduce Blood Loss During Posterior Spinal Fusion (PSF) in Patients with Adolescent Idiopathic Scoliosis (AIS): Randomized Clinical Trial
STUDY DESIGN Randomized Clinical Trial. OBJECTIVE The aim of this study was to compare the efficacy of USBS with standard-of-care surgical instruments during posterior spinal fusion (PSF) in patients with adolescent idiopathic scoliosis (AIS) by evaluating the difference in estimated blood loss per level fused (EBL/level). SUMMARY OF BACKGROUND DATA PSF surgery for AIS is often associated with high blood loss. Use of an ultrasonic bone scalpel (USBS) has been proposed to reduce blood loss during scoliosis surgery. METHODS This was a single-blinded (patient-blinded), randomized, controlled superiority trial. We randomized 66 patients with AIS undergoing PSF to the control group (osteotome) or the experimental group (USBS). The primary outcome was intraoperative EBL/level obtained from red blood cell salvage reports. One-year follow-up was available for 57 of 62 (92%) of patients. RESULTS EBL/level averaged 35 and 39 mL/level in the experimental and control groups, respectively [adjusted mean difference USBS - osteotome -8 mL/level, 95% CI: -16.4 to 0.3 mL/level, P = 0.0575]. There was no difference in curve correction [adjusted mean difference: -1.7%, 95% CI: -7.0 to 3.6%, P = 0.5321] or operative time [adjusted mean difference: -3.55 minutes, 95% CI: -22.45 to 15.46 min, P = 0.7089] between groups. Complications requiring change in routine postoperative care were noted in eight patients: two occurred in patients assigned to the experimental group and six occurred in patients assigned to the control group. CONCLUSION There was no clinically significant difference in total blood loss, EBL/level, or complications between the two groups. In contrast to reports from other centers, at our high-volume spine center, USBS did not lead to reduced blood loss during PSF for AIS. These results may not be generalizable to centers with longer baseline operative times or higher baseline average blood loss during PSF for AIS.Level of Evidence: 1.
The rule of brain hematoma pressure gradient and its influence on hypertensive cerebral hemorrhage operation
Scientific reports. 2021;11(1):4599
To comparatively study the size of and variation in the 'brain-haematoma' pressure gradient for different surgical methods for hypertensive intracerebral haemorrhage (HICH) and analyse the gradient's influence on surgical procedures and effects of the haemorrhage. Seventy-two patients with HICH treated from 1/2019 to 12/2019 were randomly divided into two groups, namely, the keyhole endoscopy and large trauma craniotomy groups, according to different operative methods. Intraoperative changes in intracranial pressure (ICP) were monitored to calculate intraoperative alterations in the 'brain-haematoma' pressure gradient. Intraoperative characteristics (operative time, bleeding volume, volume of blood transfusion, and haematoma clearance rate) and postoperative characteristics (oedema, postoperative activities of daily living (ADL) scores, mortality rate and rebleeding rate) were compared between the two groups. In the keyhole endoscopy group, ICP decreased slowly; the 'brain-haematoma' pressure gradient was large, averaging 251.1 ± 20.6 mmH(2)O, and slowly decreased. The mean operative time was 83.6 ± 4.3 min, the mean bleeding volume was 181.2 ± 13.6 ml, no blood transfusions were given, the average postoperative haematoma clearance rate was 95.6%, the rate of severe oedema was 10.9%, and the average postoperative ADL score was 85.2%. In the large trauma craniotomy group, ICP rapidly decreased after craniotomy. When the haematoma was removed, the 'brain-haematoma' pressure gradient was small, averaging 132.3 ± 10.5 mmH2O, and slowly decreased. The mean operative time was 232 ± 26.1 min, the mean bleeding volume was 412.6 ± 35.2 ml, the average volume of blood transfusion was 281.3 ± 13.6 ml, and the average postoperative haematoma clearance rate was 82.3%; moreover, the rate of severe oedema was 72.1%, and the average postoperative ADL score was 39.0%. These differences were statistically significant (P < 0.05). Neither the death rate (P > 0.05, 2.7% VS 2.8%) nor rebleeding rate (P > 0.05, 2.7% VS 2.8%) showed any obvious changes. The magnitude and variation in the 'brain-haematoma' pressure gradient for different surgical methods significantly influence surgical procedures and effects of HICH. During keyhole endoscopy surgery, this gradient was relatively large and slowly decreased; the haematoma was therefore easier to remove. Advantages of this approach include a high haematoma clearance rate, decreased bleeding volume, decreased operative time, reduced trauma, decreased postoperative brain oedema and improved postoperative recovery of neurological function.Chinese Clinical Trial Register: ChiCTR1900020655 registration in 12/01/02,019 registration in 28/02/02,020 Number: NCOMMS-20-08,091.
Easily Created Prediction Model Using Automated Artificial Intelligence Framework (Prediction One, Sony Network Communications Inc., Tokyo, Japan) for Subarachnoid Hemorrhage Outcomes Treated by Coiling and Delayed Cerebral Ischemia
Introduction Reliable prediction models of subarachnoid hemorrhage (SAH) outcomes and delayed cerebral ischemia (DCI) are needed to decide the treatment strategy. Automated artificial intelligence (AutoAI) is attractive, but there are few reports on AutoAI-based models for SAH functional outcomes and DCI. We herein made models using an AutoAI framework, Prediction One (Sony Network Communications Inc., Tokyo, Japan), and compared it to other previous statistical prediction scores. Methods We used an open dataset of 298 SAH patients, who were with non-severe neurological grade and treated by coiling. Modified Rankin Scale 0-3 at six months was defined as a favorable functional outcome and DCI occurrence as another outcome. We randomly divided them into a 248-patient training dataset and a 50-patient test dataset. Prediction One made the model using training dataset with 5-fold cross-validation. We evaluated the model using the test dataset and compared the area under the curves (AUCs) of the created models. Those of the modified SAFIRE score and the Fisher computed tomography (CT) scale to predict the outcomes. Results The AUCs of the AutoAI-based models for functional outcome in the training and test dataset were 0.994 and 0.801, and those for the DCI occurrence were 0.969 and 0.650. AUCs for functional outcome calculated using modified SAFIRE score were 0.844 and 0.892. Those for the DCI occurrence calculated using the Fisher CT scale were 0.577 and 0.544. Conclusions We easily and quickly made AutoAI-based prediction models. The models' AUCs were not inferior to the previous prediction models despite the easiness.
TRanexamic Acid In Pediatric Scoliosis Surgery (TRIPSS): A Prospective Randomized Trial Comparing High Dose and Low Dose Tranexamic Acid in Adolescent Idiopathic Scoliosis (AIS) Undergoing Posterior Spinal Fusion Surgery
STUDY DESIGN Prospective randomized double-blinded trial. OBJECTIVE The objective of this study is to determine the efficacy of high dose versus low dose tranexamic acid (TXA) in adolescent idiopathic scoliosis (AIS) corrective surgery. SUMMARY OF BACKGROUND DATA Corrective surgery for AIS is associated with significant blood loss. Evidence on the optimum TXA dose to reduce bleeding in pediatric population is scarce. METHODS 166 AIS patients aged between 10 to 21 years old, of American Society of Anesthesiologists (ASA) physical status I and II, preoperative hemoglobin > 10 g/dl, platelet count >150,000u/l and Cobb angle of >45° scheduled for elective single-stage posterior spinal fusion (PSF) surgery by two attending surgeons were included between March 2017 to November 2018. Patients were randomized into Group A (High Dose, 30 mg/kg TXA loading dose followed by 10 mg/kg/hour infusion) and Group B (Low dose, 10 mg/kg TXA loading dose followed by 1 mg/kg/hour infusion). The primary outcome was total surgical blood loss between both groups. Secondary outcomes were transfusion requirement, perioperative changes in hemoglobin and coagulation profiles, adverse events and factors that influence total blood loss. RESULTS The mean total surgical blood loss between the two groups was not significant [Group A: 928.8 ± 406.1 ml (range: 348-1857 ml); Group B: 918.1 ± 406.0 ml (range: 271-2000 ml), p = 0.865]. The mean duration of surgery was 120 minutes. One patient in each group received allogenic blood transfusion during the perioperative period. There were no significant changes in hemoglobin and coagulation profile at pre-operation, post-operation 0 hour and 48 hours. Gender, number of vertebral levels fused and duration of surgery were independently associated with total surgical blood loss. No adverse events were observed perioperatively. CONCLUSIONS Low dose TXA was as efficacious as high dose TXA in reducing blood loss and allogenic blood transfusion for AIS patients undergoing PSF surgery.Level of Evidence: 1.
Efficacy and Safety of a Thrombin-Containing Collagen-based Haemostatic Agent in Spinal Surgery: A Randomized Clinical Trial
World neurosurgery. 2021
OBJECTIVE When common haemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local haemostatic agents are used. We aimed to evaluate the haemostatic efficacy and safety of CollaStat® (Dalim Tissen Co. Ltd., Korea), a novel thrombin-containing collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal® (Baxter Healthcare, USA). METHODS We performed a randomised controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat®) or a control group (use of Floseal®). We compared successful haemostasis rate, time to haemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the two groups. RESULTS The haemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The haemostatic efficacy and safety of CollaStat® were found to be non-inferior to those of Floseal® since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal® was greater than the pre-specified non-inferiority margin of -13%. There were no statistically significant differences at the 5% level in haemostasis time, number of haemostatic agents used, hospitalisation period, and amount of drainage between the two groups. Also, there was no incidence of medical device-related serious adverse events (SAEs) or adverse events (AEs) in both groups. CONCLUSION The haemostatic efficacy and safety of CollaStat® were found to be non-inferior to those of Floseal®. Therefore, CollaStat® can be safely and effectively used in spinal surgery.
Effect of Multifunctional Cocktail Topical Applicated for Spinal Fusion on Postoperative Bleeding and Pain Control-A Prospective, Randomized, Double-Blind Controlled Trial
MINI: Bleeding and pain following lumbar fusion surgery remains a challenge for orthopedists. We designed a prospective, randomized, double-blind controlled trial and confirmed that the topical application of multifunctional cocktail we designed provide an effective and safe method for simultaneously reducing pain and bleeding after spinal fusion. STUDY DESIGN A prospective, randomized, double-blind controlled trial. OBJECTIVE To explore the effect of multifunctional cocktail for bleeding and pain control after spinal fusion. SUMMARY OF BACKGROUND DATA Managing postoperative bleeding and pain following spinal fusion remains a challenge. Topical application of tranexamic acid (TXA) or anaesthetic agents for bleeding or pain management just started recently, and the multifunctional cocktail for bleeding and pain control simultaneously after spinal fusion have never been published. METHODS 90 patients who underwent posterior spinal fusion were enrolled in this study. The multifunctional cocktail was injected into the incision before wound closure in the cocktail group. In the control group, an equal volume of normal saline was injected and a patient-controlled analgesic (PCA) pump was used. Visual analogue scale (VAS) score; opioid consumption; intraoperative, postoperative, hidden and total blood loss (IBL, PBL, HBL, and TBL); volume of drainage (WD), haematocrit (Hct) levels of drainage; haemoglobin (Hb) levels; and complications were compared between the two groups. RESULTS There were no differences in the VAS within 48 h after surgery between the two groups. However, the opioid dosages in the control group were higher than those in the cocktail group. The PBL, TBL and HBL were lower in the cocktail group than in the control group. The drainage volume showed no differences between the two groups; however, the Hct level of drainage at 24 h after surgery was lower in the cocktail group than in the control group. The Hb level was higher in the cocktail group than in the control group at POD3. Thirteen patients with unbearable nausea and vomiting in the control group, while no complications in the cocktail group. CONCLUSION Topical application of a multifunctional cocktail that we designed provides an effective and safe method for reducing pain and bleeding after spinal fusion.Level of Evidence: 1.
The Effect of Tranexamic Acid Administration on Early Endothelial Damage Following Posterior Lumbar Fusion Surgery
Journal of clinical medicine. 2021;10(7)
Tranexamic acid (TXA) protects against endothelial glycocalyx injury in vitro. We aimed to evaluate whether TXA could protect against endothelial glycocalyx degradation in patients undergoing posterior lumbar fusion surgery. Patients aged 30-80 years were enrolled. The TXA group was administered a loading dose of 10 mg/kg, followed by a 1 mg/kg/h infusion. Serum syndecan-1 and heparan sulfate concentrations, which are biomarkers of glycocalyx degradation, were measured at preoperative baseline (T0), immediately post-surgery (T1), and 2 h post-surgery (T2). Postoperative complications were assessed, including hypotension, desaturation, and acute kidney injury. Among the 121 patients who completed the study, 60 received TXA. There were no significant differences in the marker concentrations at each time point. However, the postoperative increase in syndecan-1 levels from baseline was significantly attenuated in the TXA group compared with the control group (median (interquartile range); T1 vs. T0: -1.6 (-5.3-2.6) vs. 2.2 (-0.7-4.8), p = 0.001; T2 vs. T0: 0.0 (-3.3-5.5) vs. 3.6 (-0.1-9.3), p = 0.013). Postoperative complications were significantly associated with the magnitude of the change in syndecan-1 levels (for T2 vs. T0: odds ratio: 1.08, 95% confidence interval: 1.02-1.14, p = 0.006). TXA administration was associated with reduced syndecan-1 shedding in patients undergoing posterior lumbar fusion surgery.
Equal Ratio Ventilation Reduces Blood Loss During Posterior Lumbar Interbody Fusion Surgery
STUDY DESIGN A prospective randomized double-blinded study. OBJECTIVE The aim of this study was to compare the effect of two different ventilator modes (inspiratory to expiratory ratio (I:E ratio) of 1:1 and 1:2) on intraoperative surgical bleeding in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. SUMMARY OF BACKGROUND DATA During PLIF surgery, a considerable amount of blood loss is anticipated. In the prone position, engorgement of the vertebral vein increases surgical bleeding. We hypothesized that equal ratio ventilation (ERV) with I:E ratio of 1:1 would lower peak inspiratory pressure (PIP) in the prone position and consequentially decrease surgical bleeding. METHODS Twenty-eight patients were randomly assigned to receive either ERV (ERV group, n = 14) or conventional ventilation with I:E ratio of 1:2 (control group, n = 14). Hemodynamic and respiratory parameters were measured at 5 min after anesthesia induction, at 5 min after the prone position, at the time of skin closure, and at 5 min after turning to the supine position. RESULTS The amount of intraoperative surgical bleeding in the ERV group was significantly less than that in the control group (975.7 ± 349.9 mL vs. 1757.1 ± 1172.7 mL, P = 0.03). Among other hemodynamic and respiratory parameters, PIP, plateau inspiratory pressure (Pplat) were significantly lower and dynamic lung compliance (Cdyn) was significantly higher in the ERV group than those of the control group throughout the study period, respectively (all P < 0.05). CONCLUSION Compared to conventional ratio ventilation, ERV provided lower PIP and reduced intraoperative surgical blood loss in patients undergoing PLIF surgery.Level of Evidence: 2.