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.
Is Platelet-Rich Plasma Effective in Enhancing Spinal Fusion? Systematic Overview of Overlapping Meta-Analyses
Global spine journal. 2021;:2192568220988278
STUDY DESIGN Systematic review. OBJECTIVES We performed this systematic overview on overlapping meta-analyses that analyzed the role of platelet-rich plasma(PRP) in enhancing spinal fusion and identify which study provides the current best evidence on the topic and generate recommendations for the same. MATERIALS AND METHODS We conducted independent and duplicate electronic database searches in PubMed, Web of Science, Embase, Cochrane Database of Systematic Reviews, and Database of Abstracts of Reviews of Effects till October-2020 for meta-analyses that analyzed the role of PRP in spinal fusion procedures. Methodological quality assessment was made using Oxford Levels of Evidence, AMSTAR scoring, and AMSTAR 2 grades. We then utilized the Jadad decision algorithm to identify the study with highest quality to represent the current best evidence to generate recommendations. RESULTS 3 meta-analyses fulfilling the eligibility criteria were included. The AMSTAR scores of included studies varied from 5-8(mean:6.3) and all included studies had critically low reliability in their summary of results due to their methodological flaws according to AMSTAR 2 grades. The current best evidence showed that utilization of PRP was not associated with significant improvement in patient-reported outcomes such as Visual Analog Score for pain compared to the standard fusion procedure. Moreover, PRP was found to be associated with lower fusion rates. CONCLUSION Based on this systematic overview, the effectiveness of PRP as a biological agent in augmenting spinal fusion is limited. Current evidence does not support the use of PRP as an adjuvant to enhance spinal fusion.
Platelet-Rich Plasma Versus Corticosteroid Injection for Lumbar Spondylosis and Sacroiliac Arthropathy: A Systematic Review of Comparative Studies
This systematic review compares clinical outcomes between platelet-rich plasma (PRP) and corticosteroid injections for the treatment of lumbar spondylosis and sacroiliac arthropathy. A systematic review was registered with the International Prospective Register of Systematic Reviews (PROSPERO) and performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using the Pubmed, SCOPUS, and Ovid MEDLINE databases. All level I-III evidence comparative studies published in the English language investigating the clinical outcomes between PRP and corticosteroid injections for the treatment of lumbar spondylosis and sacroiliac arthropathy were included. Five studies (242 patients, 114 PRP, 128 corticosteroid) were analyzed. One randomized study was level I evidence, two randomized studies were level II, and two non-randomized studies were level III. Final follow-up ranged from six weeks to six months. Four studies found that both PRP and corticosteroid treatment led to a statistically significant reduction in the visual analog scale (VAS). One found that only the PRP group led to a statistically significant reduction in VAS. Three studies found more significant improvements in one or more clinical outcome scores among PRP patients as compared with corticosteroid patients at the three- to six-month follow-up. Two studies found no difference in outcome score improvements between the two groups at six- to 12-week follow-up. There were no reports of major complications. There were no significant differences in minor complication rates between the two groups. In conclusion, both PRP and corticosteroid injections are safe and effective options for the treatment of lumbar spondylosis and sacroiliac arthropathy. There is some evidence that PRP injection is a more effective option at long-term follow-up compared with corticosteroid injection. Further randomized controlled trials with longer-term follow-up are necessary to compare its long-term efficacy.
EXPRESS: Therapeutic Hypothermia for Intracerebral Hemorrhage: Systematic Review and Meta-Analysis of the Experimental and Clinical Literature
International journal of stroke : official journal of the International Stroke Society. 2021;:17474930211044870
BackgroundIntracerebral hemorrhage (ICH) remains the deadliest form of stroke worldwide, inducing neuronal death through a wide variety of pathways. Therapeutic hypothermia (TH) is a robust and well studied neuroprotectant widely used across a variety of specialties. AimsThis review summarizes results from preclinical and clinical studies to highlight the overall effectiveness of TH to improve long-term ICH outcomes while also elucidating optimal protocol regimens to maximize therapeutic effect.Summary of Review A systematic review was conducted across three databases to identify trials investigating the use of TH to treat ICH. A random-effects meta-analysis was conducted on preclinical studies, looking at neurobehavioral outcomes, blood brain barrier breakdown (BBB), cerebral edema, hematoma volume, and tissue loss. Several mixed-methods meta-regression models were also performed to adjust for variance and variations in hypothermia induction procedures. 21 preclinical studies and 5 human studies were identified. The meta-analysis of preclinical studies demonstrated a significant benefit in behavioral scores (ES=-0.43, p=0.02), cerebral edema (ES=1.32, p=0.0001), and BBB (ES=2.73, p=<0.00001). TH was not found to significantly affect hematoma expansion (ES=-0.24, p=0.12) or tissue loss (ES=0.06, p=0.68). Clinical study outcome reporting was heterogeneous, however there was recurring evidence of TH-induced edema reduction. ConclusionsThe combined preclinical evidence demonstrates that TH reduced multiple cell death mechanisms initiated by ICH, yet there is no definitive evidence in clinical studies. The cooling strategies employed in both preclinical and clinical studies were highly diverse, and focused refinement of cooling protocols should be developed in future preclinical studies. The current data for TH in ICH remains questionable despite the highly promising indications in preclinical studies. Definitive randomized controlled studies are still required to answer this therapeutic question.
The efficacy and safety of topical tranexamic acid for spinal surgery: a meta-analysis
Current pharmaceutical design. 2021
BACKGROUND Spinal surgeries are often accompanied by significant blood loss both intraoperatively and postoperatively. Excessive blood loss caused by surgery may lead to several harmful medical consequences. Tranexamic acid (TXA) is a kind of antifibrinolytic agent that has been widely used in spinal surgery. Currently, it is commonly accepted that intravenous TXA (ivTXA) can reduce blood loss in spinal fusion surgeries. Compared with ivTXA, topical TXA (tTXA) seems to be much easier to administer. This advantage provides a maximum concentration of TXA at the hemorrhagic site with little to no TXA entering the circulation. OBJECTIVE To evaluate the effect of tTXA on blood loss during and after spinal surgery via a comprehensive meta-analysis of the published data in randomized controlled trials (RCTs) and other comparative cohort studies. METHODS A comprehensive search of PubMed, EMBASE, the Web of Science, and the Cochrane Central Register of Controlled Trials were performed for RCTs and other comparative cohort studies on the effect of tTXA on blood loss during and after spinal surgery. The outcomes were total blood loss, hidden blood loss, intraoperative blood loss, total postoperative drainage volume, drainage tube duration postoperatively, drainage volume and drainage of blood content at postoperative day (POD) 1 and POD2, length of hospital stay, number of patients who received a blood transfusion, serum HB level at POD1, operative timespan, side effects, and complications. The final search was performed in October 2020. We followed the PRISMA guideline, and the registration number is INPLASY202160028. RESULTS In total, six studies with 481 patients were included. tTXA treatment, compared with the control conditions, can significantly reduce the total blood loss, hidden blood loss, total postoperative drainage volume, and several patients receiving blood transfusions; reduce the drainage volume and drainage of blood content at POD1; shorten the drainage tube duration postoperatively and length of hospital stay, and enhance the serum HB level at POD1 for spinal surgery. tTXA treatment did not significantly influence the intraoperative blood loss, drainage volume, or drainage of blood content at POD2 or the operative duration. CONCLUSION Compared with control conditions, tTXA has high efficacy in reducing blood loss, and drainage volume enable quick rehabilitation and has a relatively high level of safety in spinal surgery.
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.
Timing of temporizing neurosurgical treatment in relation to shunting and neurodevelopmental outcomes in post-hemorrhagic ventricular dilatation of prematurity: a meta-analysis
The Journal of pediatrics. 2021
OBJECTIVE To determine the relationship between timing of initiation of temporizing neurosurgical treatment and rates of ventriculoperitoneal shunting (VPS) and neurodevelopmental impairment in premature infants with post-hemorrhagic ventricular dilatation (PHVD). STUDY DESIGN We searched MEDLINE, EMBASE, CINAHL, Web of Science, Cochrane Database of Systematic Reviews, and Cochrane Center Register of Controlled Trials for studies that reported on premature infants with PHVD who received TNP. Timing of TNP, gestational age, birth weight, and outcomes of conversion to VPS, moderate-to-severe NDI, infection, TNP revision, and death at discharge were extracted. RESULTS Sixty-two full-length articles and six conference abstracts (n=2533 patients) published through November 2020 were included. Pooled rate for conversion to VPS was 60.5% (95% CI=54.9-65.8), moderate-severe NDI 34.8% (95% CI=27.4-42.9), infection 8.2% (95% CI=6.7-10.1), revision 14.6% (95% CI=10.4-20.1), and death 12.9% (95% CI=10.2-16.4). Average age at TNP was 24.2+/-11.3 days. On meta-regression, older age at TNP was a predictor of conversion to VPS (p<0.001) and NDI (p<0.01). Later year of publication predicted increased survival (p<0.01) and external ventricular drains were associated with more revisions (p=0.001). Tests for heterogeneity reached significance for all outcomes and qualitative review showed heterogeneity in study inclusion and diagnosis criteria for PHVD and initiation of TNP. CONCLUSIONS Later timing of TNP predicted higher rates of conversion to VPS and moderate-severe NDI. Outcomes were often reported relative to number of patients who received TNP and criteria for study inclusion and initiation of TNP varied across institutions. There is need for more comprehensive outcome reporting that includes all infants with PHVD regardless of treatment.
Tranexamic acid given into wound reduces postoperative drainage, blood loss, and hospital stay in spinal surgeries: a meta-analysis
Journal of orthopaedic surgery and research. 2021;16(1):401
BACKGROUND Although intravenous tranexamic acid administration (ivTXA) has prevailed in clinical antifibrinolytic treatment, whether it increases thromboembolic risks has remained controversial. As a potent alternative to ivTXA, topical use of TXA (tTXA) has been successfully applied to attenuate blood loss in various surgical fields while minimizing systemic exposure to TXA. This meta-analysis was conducted to gather scientific evidence for tTXA efficacy on reducing postoperative drainage, blood loss, and the length of hospital stay in spine surgeries. OBJECTIVES To examine whether topical use of TXA (tTXA) reduces postoperative drainage output and duration, hidden blood loss, hemoglobin level drop, hospital stay, and adverse event rate, we reviewed both randomized and non-randomized controlled trials that assessed the aforementioned efficacies of tTXA compared with placebo in patients undergoing cervical, thoracic, or lumbar spinal surgeries. METHODS An exhaustive literature search was conducted in MEDLINE and EMBASE databases from January 2000 through March 2020. Measurable outcomes were pooled using Review Manager (RevMan) version 5.0 in a meta-analysis. RESULTS Significantly reduced postoperative drainage output (weighted mean difference [WMD]= - 160.62 ml, 95% confidence interval (95% CI) [- 203.41, - 117.83]; p < .00001) and duration (WMD= - 0.75 days, 95% CI [- 1.09, - 0.40]; p < .0001), perioperative hidden blood loss (WMD= - 91.18ml, 95% CI [- 121.42, - 60.94]; p < .00001), and length of hospital stay (WMD= - 1.32 days, 95% CI [- 1.90, - 0.74]; p < .00001) were observed in tTXA group. Pooled effect for Hb level drop with tTXA vs placebo crossed the equivalent line by a mere 0.05 g/dL, with the predominant distribution of 95% confidence interval (CI) favoring tTXA use. CONCLUSIONS With the most comprehensive literature inclusion up to the present, this meta-analysis suggests that tTXA use in spinal surgeries significantly reduces postoperative drainage, hidden blood loss, and hospital stay duration. The pooled effect also suggests that tTXA appears more effective than placebo in preserving postoperative Hb level, which needs further validation by future studies.
Patients undergoing spinal surgery (13 studies).
Topical use of tranexamic acid (tTXA).
Those in the tTXA group showed significantly reduced postoperative drainage output (weighted mean difference (WMD) = - 160.62 ml) and duration (WMD = - 0.75 days), perioperative hidden blood loss (WMD = - 91.18ml), and length of hospital stay (WMD = - 1.32 days).
The Efficacy and Safety of Epsilon-Aminocaproic Acid for Perioperative Blood Management in Spinal Fusion Surgery: A systematic review and meta-analysis
World neurosurgery. 2021
BACKGROUND Perioperative blood loss is a major concern in spinal fusion surgery, which often requires blood transfusion. A large amount of perioperative blood loss might increase the risks of various perioperative complications. Recently, there has been a series of clinical studies focusing on the perioperative administration of epsilon-aminocaproic acid (EACA) in spinal fusion surgery. The aim of this review was to evaluate the efficacy and safety of EACA in spinal fusion surgery. METHODS We systematically searched electronic databases (MEDLINE, EMBASE, PubMed, and Cochrane Central Register of Controlled Trials) up to April 2021. The perioperative blood loss, blood transfusion and complication data were extracted and analysed by RevMan Manager 5.3. RESULTS Finally, six randomized controlled studies, involving 398 patients undergoing spinal fusion surgery, were enrolled in this systematic review. Compared with the blank control group, the EACA group had significantly lower total perioperative blood loss, postoperative blood loss, postoperative hemoglobin, postoperative blood transfusion units, total blood transfusion units, and postoperative red blood cell transfusion units. Additionally, no significant differences were observed between the EACA group and control group in intraoperative blood loss, intraoperative blood transfusion units, intraoperative crystalloid administered, hospital stays, operative time, perioperative respiratory complications, and wound bleeding. CONCLUSIONS EACA in patients undergoing spinal fusion surgery is effective in perioperative hemostasis without increasing the incidence of postoperative complications. However, the long-term adverse side of EACA in spinal fusion surgery still need more large-scale trials.