Therapeutic Application of Fibrinogen in Spine Surgery: A Review Article
International journal of spine surgery. 2021
BACKGROUND The aim of this review is to investigate current uses of fibrinogen as a tool to reduce operative and postoperative blood loss in different surgical fields especially orthopedic spine surgery. This is a systematic review. METHODS MEDLINE (via Ovid 1946 to June 1, 2020) and Embase (via Ovid 1947 to June 1, 2020) were searched using the keywords "fibrinogen", "surgery", and "spine" for relevant studies. The search strategy used text words and relevant indexing to identify articles discussing the use of fibrinogen to control surgical blood loss. RESULTS The original literature search yielded 407 articles from which 68 duplications were removed. Three hundred thirty-nine abstracts and titles were screened. Results were separated by surgical specialties. CONCLUSIONS Multiple studies have looked at the role of fibrinogen for acute bleeding in the operative setting. The current evidence regarding the use of fibrinogen concentrate in spine surgery is promising but limited, even though this is a field with the potential for severe hemorrhage. Further trials are required to understand the utility of fibrinogen concentrate as a first-line therapy in spine surgery and to understand the importance of target fibrinogen levels and subsequent dosing and administration to allow recommendations to be made in this field.
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.
The Efficacy of Combined Medication With Methylprednisolone and Erythropoietin in the Treatment of Ischemia-Reperfusion Injury to the Spinal Cord in Patients With Cervical Spondylotic Myelopathy
Introduction Cervical myelopathy (CM) is caused by degenerative or congenital changes in the discs and soft tissues of the cervical spine, leading to chronic compression of the spinal cord. The current treatment for moderate-to-severe CM is surgical decompression, which is effective in most cases; however, it can cause inflammation of the nervous system and spinal cord reperfusion injury, resulting in perioperative neurological complications and suboptimal neurological recovery. The aim of this study was to investigate the therapeutic effects of the combination of erythropoietin and methylprednisolone in the treatment of ischemia-reperfusion injury to the spinal cord and to analyze its effects on the levels of interleukin-1 beta (IL-1β), interleukin-1 receptor antagonist (IL-1RA), and interleukin-8 (IL-8). Materials and methods This study included 110 patients admitted to the hospital due to cervical spondylotic myelopathy. They were randomized into two groups of 55 patients each: a control and an observation group. In both groups of patients, fusion internal fixation and anterior cervical discectomy were performed. The difference, however, was that the control group received a rapid intravenous injection of 30 mg/kg methylprednisolone 30 minutes prior to spinal cord decompression, while the observation group received an intravenous injection of 30 mg/kg methylprednisolone and 3,000 U/kg erythropoietin 30 minutes before spinal cord decompression. The study was approved by the Hospital Ethical Committee of the Dow University of Health Sciences, Karachi. The neurological function of both groups of patients was assessed before the procedure and three months after the treatment using the Japanese Orthopedic Association (JOA) method of assessing spinal cord function (40-point rating method). Enzyme-linked immunosorbent assay (ELISA) was performed to measure the levels of neuron-specific enolase (NSE), S-100β, IL-1RA, IL-1β, and IL-8 in both groups. The quality of life of patients in both groups was assessed three months after the treatment with the World Health Organization Quality of Life assessment instrument (WHOQOL-100). Results Before the treatment, there was no significant variance between the two groups in the JOA score and the 40-point rating method. Similarly, there was no significant difference in the levels of IL-1β, IL-1RA, and IL-8 between the two groups (p-value = 0.262, 0.387, and 0.154 respectively) prior to the treatment. Three months after the treatment, the levels of IL-1β and IL-8 in the observation group were 21.83 ±3.65 ng/l and 357.07 ±32.36 ng/l respectively, both lower than the control group value (p-value = 0.026, 0.028 respectively). The level of IL-1RA in follow-up was 21.59 ±1.15 ng/l, which was higher than that in the control group. Three months after the treatment, all the WHOQOL-100 parameters of the observation group for psychology, physiology, social relations, independence, spirituality, environment, and general quality of life were higher than those of the control group; the variance among the groups was statistically significant (p-value: <0.001). Conclusions The combination therapy with erythropoietin and methylprednisolone is effective for ischemia-reperfusion injuries of the spinal cord. It also reduces S-100β and NSE, inhibits IL-1β, and increases IL-8 and IL-1RA. Therefore, it preserves and improves spinal nerve function and the quality of life of patients.
Effects of controlled hypotension with restrictive transfusion on intraoperative blood loss and systemic oxygen metabolism in elderly patients who underwent lumbar fusion
BACKGROUND The effects of restrictive fluid therapy combined with controlled hypotension in the elderly on systemic oxygen metabolism and renal function are clinical concerns. The aim of this study was to evaluate blood loss, oxygen metabolism, and renal function in different levels of controlled hypotension induced by intravenous nitroglycerin, in combination with limited infusion, in elderly patients undergoing posterior lumbar fusion. METHODS A total of 40 patients, aged 60-75 with ASA grade II or III, who were planned for posterior lumbar fusion were randomly allocated into two groups: experimental group [target mean arterial pressure 65 mmHg (MAP 65) or control group (MAP 75)]. Indicators for blood loss, hemodynamic, systemic oxygen metabolism, and renal function evaluation index were recorded before operation (T0), 1 h after induced hypotension (T1), 2 h after hypotension (T2), and in recovery (T3). We compared changes in these parameters between groups to evaluate the combined effects of controlled hypotension with restrictive infusion. RESULTS CI, DO(2)I, and VO(2)I were lower in both groups at T1-T3 compared with T0 (p < 0.05). DO(2)I and VO(2)I in the MAP 65 group were lower than the MAP 75 group after operation. In both groups, SCysC increased at T1, T2, and T3 (p < 0.05) compared with T0. CONCLUSIONS Restrictive transfusion and control MAP at 65 mmHg can slightly change in renal function and reduce the risk of insufficient oxygen supply and importantly have no significant effect on blood loss and postoperative complications. TRIAL REGISTRATION ChiCTR-INR-16008153 . Registered on 25 March 2016.
Comparison of the curative effect and prognosis of stereotactic drainage and conservative treatment for moderate and small basal ganglia haemorrhage
BMC neurology. 2021;21(1):268
BACKGROUND Minimally invasive surgery has achieved good results in the treatment of cerebral haemorrhage.However, no large-scale clinical study has demonstrated that surgical treatment of cerebral haemorrhages less than 30 ml can improve the curative effect. Our study explored the efficacy and complication of stereotactic drainage based on the amount of cerebral hemorrhage (15-30 ml) in hypertensive basal ganglia. METHOD Sixty patients with hypertensive basal ganglia haemorrhages were divided into a control group and an experimental group with 30 patients in each group. Patients in the control group were treated conservatively. In contrast, those in the experimental group received stereotactic drainage, and urokinase was injected into the haematoma cavity after the operation. The haematoma volume at admission and 1, 3, 7 and 30 days after treatment and National Institute of Health stroke scale(NIHSS) score data were recorded. Complications after treatment in the two groups of data were compared and analysed. RESULT No significant differences in age, sex, time of treatment after onset, admission blood pressure, admission haematoma volume or admission NIHSS score were noted between these two groups (P > 0.05). After treatment, significant differences in haematoma volume were noted between the two groups on the 1st, 3rd, 7th and 30th days after treatment (P < 0.05). The amount of hematoma of patients in the experimental group was significantly reduced compared with that in the control group, and the NIHSS scores were significantly different on the 3rd, 7th and 30th days after treatment. The neurological deficit scores of patients in the experimental group were significantly reduced compared with those in the control group, and the incidence of pulmonary infection and venous thrombosis in the lower limbs of patients in the experimental group were significantly reduced (P < 0.05). ROC curve analysis showed that stereotactic drainage affected the early neurological function of patients with small and medium basal ganglia haemorrhages. CONCLUSION For patients with small and medium basal ganglia haemorrhages, stereotactic drainage can be used due to the faster drainage speed of haematomas after operation, which is beneficial to the recovery of neurological function and reduce complications.
Role of tranexamic acid in blood loss control and blood transfusion management of patients undergoing multilevel spine surgery: A meta-analysis
BACKGROUND This study aimed to explore the role of tranexamic acid (TXA) in blood loss control and blood transfusion management of patients undergoing multilevel spine surgery. METHODS In this meta-analysis, a comprehensive search of literatures was performed from PubMed, Embase, Cochrane Library, and Web of Science from inception to June 23rd, 2020. Weighed mean difference (WMD) was used as the effect size for measurement data, and risk ratio for enumeration data. Publication bias was assessed by Begg test. RESULTS Totally 23 studies (11 randomized controlled trials and 12 cohort studies) involving 1621 participants were enrolled in this meta-analysis. The results showed that the administration of TXA can significantly decrease the intraoperative [WMD: -215.655, 95%CI: (-307.462, -123.847), P < .001], postoperative [WMD: -69.213, 95%CI: (-104.443, -33.983), P = .001] and total [WMD: -284.388, 95%CI: (-437.66, -131.116), P < .001] volumes of blood loss of patients undergoing multilevel spine surgery. It can also significantly reduce the intraoperative [WMD: -333.775, 95%CI: (-540.45, -127.099), P = .002] and postoperative [WMD: -114.661, 95%CI: (-219.58, -9.742), P = .032] volumes of transfusion. In addition, TXA was found to significantly increase the preoperative [WMD: 0.213, 95%CI: (0.037, 0.389), P = .018] and postoperative [WMD: 0.433, 95%CI: (0.244, 0.622), P < .001] hemoglobin levels as well as the preoperative platelet count [WMD: 14.069, 95%CI: (0.122, 28.015), P = .048]. CONCLUSION The administration of TXA can effectively reduce blood loss and transfusion, and improve hemoglobin levels and preoperative platelet count in patients undergoing multilevel spine surgery.
Oral- is as Effective as Intravenous Tranexamic Acid at Reducing Blood Loss in Thoracolumbar Spinal Fusions: A Prospective Randomized Trial
STUDY DESIGN A prospective randomized trial at a university affiliated tertiary medical center between February 2017 and March 2020. OBJECTIVE Compare perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with IV versus PO TXA. SUMMARY OF BACKGROUND DATA The use of antifibrinolytic agents such as tranexamic acid (TXA) to decrease operative blood loss and allogenic blood transfusions is well documented in the literature. While evidence supports the use of intravenous (IV) and topical formulations of TXA in spine surgery, the use of oral (PO) TXA has not been studied. METHODS 261 patients undergoing thoracolumbar fusion were randomized to receive 1.95 g of PO TXA 2 hours preoperatively or 2 g IV TXA (1 g before incision and 1 g before wound closure) intraoperatively. The sample was further stratified into 3 categories based on number of levels fused (1-2 level fusions, 3-5, and >5). The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. Equivalence analysis was performed with a two one-sided test (TOST). RESULTS 137 patients received IV and 124 received PO TXA. The average age was 62 ± 13 years (Mean ± SD), including 141 females and 120 males. Revision cases comprised of 67% of the total sample. Patient demographic factors were similar between groups except for weight, BMI, and preoperative platelet count. The mean reduction of hemoglobin was similar between IV and PO groups (3.56 vs. 3.28 g/dL, respectively; P = 0.002, equivalence). IV TXA group had a higher transfusion rate compared to PO TXA group (22 patients [19%] vs. 12 patients [10%]; P = 0.03). In addition, IV group had longer length of stay (LOS) than PO group (4.4 vs. 3.7 days; P = 0.02). CONCLUSION Patients treated with IV and PO TXA experienced the same perioperative blood loss after small and large spinal fusions. In subgroup analysis, the intermediate (3-5 level) spinal fusions had less blood loss with PO TXA than IV TXA. Given its lower cost, PO TXA represents a superior alternative to IV TXA in patients undergoing elective posterior thoracolumbar fusion and may improve healthcare cost-efficiency in the studied population.Level of Evidence: 1.
Effect of remote ischemic preconditioning on cerebral vasospasm, biomarkers of cerebral ischemia, and functional outcomes in aneurysmal subarachnoid hemorrhage (ERVAS): A randomized controlled pilot trial
Brain circulation. 2021;7(2):104-110
BACKGROUND Cerebral vasospasm can complicate aneurysmal subarachnoid hemorrhage (aSAH), contributing to cerebral ischemia. We explored the role of remote ischemic preconditioning (RIPC) in reducing cerebral vasospasm and ischemia and improving outcomes after aSAH. MATERIALS AND METHODS Patients with ruptured cerebral aneurysm undergoing surgical clipping and meeting the trial criteria were randomized to true RIPC (n = 13) (inflating upper extremity blood pressure cuff thrice to 30 mmHg above systolic pressure for 5 min) or sham RIPC (n = 12) (inflating blood pressure cuff thrice to 30 mmHg for 5 min) after ethical approval. A blinded observer assessed outcome measures-cerebral vasospasm and biomarkers of cerebral ischemia. We also evaluated the feasibility and safety of RIPC in aSAH and Glasgow Outcome Scale-Extended (GOSE). RESULTS Angiographic vasospasm was seen in 9/13 (69%) patients; 1/4 patients (25%) in true RIPC group, and 8/9 patients (89%) in sham RIPC group (P = 0.05). Vasospasm on transcranial Doppler study was diagnosed in 5/25 (20%) patients and 1/13 patients (7.7%) in true RIPC and 4/12 patients (33.3%) in sham RIPC group, (P = 0.16). There was no difference in S100B and neuron-specific enolase (NSE) levels over various time-points within groups (P = 0.32 and 0.49 for S100B, P = 0.66 and 0.17 for NSE in true and sham groups, respectively) and between groups (P = 0.56 for S100B and P = 0.31 for NSE). Higher GOSE scores were observed with true RIPC (P = 0.009) unlike sham RIPC (P = 0.847) over 6-month follow-up with significant between group difference (P = 0.003). No side effects were seen with RIPC. CONCLUSIONS RIPC is feasible and safe in patients with aSAH and results in a lower incidence of vasospasm and better functional outcome.
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.
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).