Prophylactic cryoprecipitate transfusion in patients undergoing scoliosis surgery: A randomised-controlled trial
Journal of perioperative practice. 2022;:17504589221132393
BACKGROUND Scoliosis surgeries in adults often have a high risk of massive blood loss and significant transfusion of blood products during and after surgery. It is not known whether early cryoprecipitate therapy is useful in reducing blood loss and transfusion requirements. The objective of this randomised, prospective placebo control study was to evaluate whether prophylactic administration of cryoprecipitate would reduce blood loss and transfusion requirements during scoliosis surgery. METHODS Eighty adult patients scheduled to undergo elective scoliosis correction were randomly assigned to receive either ten units of cryoprecipitate before incision (cryo group) or an equivalent volume of 0.9% saline (placebo group). Blood loss, transfusion requirements, coagulation parameters and complications were assessed. RESULTS No significant differences were found in the volume of transfused blood products, intraoperative estimated blood loss between the intervention and placebo groups. Postoperative blood loss was significantly lower in the cry group when compared to the other group. During adult surgical correction of scoliosis, prophylactic administration of cryoprecipitate did not diminish the amount of transfused blood products or decrease intraoperative blood loss. CONCLUSION It could be concluded that the prophylactic administration of cryoprecipitate shows no differences in intraoperative blood loss and transfusion requirements during scoliosis surgery.
Efficacy and Safety Profile of Tranexamic Acid in Traumatic Thoracolumbar Fracture Management: A Systematic Review and Meta-Analysis
International journal of spine surgery. 2022
OBJECTIVE In this article, the authors systematically evaluated the efficacy and safety of tranexamic acid (TXA) in surgeries for spinal trauma. METHODS Potentially relevant academic articles were identified from the Cochrane Library, MEDLINE, PubMed, and Google Scholar. Secondary sources were identified from the references of the included literature. RevMan software was used to analyze the pooled data. RESULTS A total of 7 randomized controlled trials (RCTs) and 2 non-RCTs were included in the review. There were significant differences in total blood loss (standard mean difference [SMD] = -2.54 [95% CI, -3.72, -1.37], P = 0.0001), intraoperative blood loss (SMD = -0.96 [95% CI, -1.28, -0.64], P < 0.00001), postoperative blood loss (SMD = -1.42 [95% CI, -1.72, -1.11], P < 0.00001), and length of hospital stay (SMD = -3.73 [95% CI, -4.41, -3.06], P = 0.00001). No significant differences were found regarding transfusion requirement, operative duration, deep vein thrombosis, and pulmonary embolism between the 2 groups. CONCLUSIONS The present meta-analysis indicates that the use of TXA in spinal surgery decreases blood loss and duration of hospital stay while not increasing the risk of side effects such as deep vein thrombosis and pulmonary embolism. CLINICAL RELEVANCE The study aims to provide clinicians who operate on spine trauma with information on the use of tranexamic acid to decrease blood loss and related complications.
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.
Safety and efficacy of prothrombin complex concentrate (PCC) for anticoagulation reversal in patients undergoing urgent neurosurgical procedures: a systematic review and metaanalysis
Neurosurgical review. 2020
Anticoagulant therapy poses a significant risk for patients undergoing emergency neurosurgery procedures, necessitating reversal with prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP). Data on PCC efficacy lack consistency in this setting. This systematic review and metaanalysis aimed to evaluate efficacy and safety of PCC for anticoagulation reversal in the context of urgent neurosurgery. Articles from PubMed, Embase, and Cochrane databases were screened according to the PRISMA checklist. Adult patients receiving anticoagulation reversal with PCC for emergency neurosurgical procedures were included. When available, patients who received FFP were included as a comparison group. Pooled estimates of observational studies were calculated for efficacy and safety outcomes via random-effects modeling. Initial search returned 4505 articles, of which 15 studies met the inclusion criteria. Anticoagulants used included warfarin (83%), rivaroxaban (6.8%), phenprocoumon (6.1%), apixaban (2.2%), and dabigatran (1.5%). The mean International Normalized Ratio (INR) prePCC administration ranged from 2.3 to 11.7, while postPCC administration from 1.1 to 1.4. All-cause mortality at 30 days was 27% (95%CI 21, 34%; I(2) = 44.6%; p-heterogeneity = 0.03) and incidence of thromboembolic events was 6.00% among patients treated with PCC (95%CI 4.00, 10.0%; I(2) = 0%; p-heterogeneity = 0.83). Results comparing PCC and FFP demonstrated no statistically significant differences in INR reversal, mortality, or incidence of thromboembolic events. This metaanalysis demonstrated adequate safety and efficacy for PCC in the reversal of anticoagulation for urgent neurosurgical procedures. There was no significant difference between PCC and FFP, though further trials would be useful in demonstrating the safety and efficacy of PCC in this setting.
Prophylactic fibrinogen concentrate administration in surgical correction of paediatric craniosynostosis: A double-blind placebo-controlled trial
European journal of anaesthesiology. 2020
BACKGROUND Surgical craniosynostosis repair in children is associated with massive blood loss and significant transfusion of blood products. Fibrinogen concentrate is claimed to be useful in reducing blood loss and transfusion requirements. OBJECTIVE We investigated whether prophylactic administration of fibrinogen concentrate will reduce blood loss and transfusion requirements during paediatric craniofacial surgery. DESIGN Randomised, placebo-controlled, double-blind clinical trial. SETTING University medical centre. PATIENTS A total of 114 infants and children up to 25 months of age (median age 10 months). INTERVENTION Surgical craniosynostosis repair by calvarial remodelling was performed in each patient. Patients were randomised to receive prophylactic fibrinogen concentrate (Haemocomplettan P) at a mean dose of 79 mg kg body weight or placebo. MAIN OUTCOME MEASURES Primary outcome was the volume of transfused blood products. Secondary outcomes were peri-operative blood loss, duration of surgery, length of stay in the paediatric ICU, length of hospital stay, postoperative complications and adverse effects of fibrinogen concentrate infusion. RESULTS No significant differences (P < 0.05) were found in the volume of transfused blood products (median 29 ml kg body weight vs. 29 ml kg body weight), intra-operative estimated blood loss (45 vs. 46 ml kg), calculated blood loss (57 vs. 53 ml kg), or postoperative blood loss (24 vs. 24 ml kg) between the intervention and placebo groups. In addition, duration of surgery, length of stay in the paediatric ICU, hospital stay and complications were not significantly different between the two groups. CONCLUSION During surgical craniosynostosis repair in young children, prophylactic administration of high-dose fibrinogen concentrate did not reduce the amount of transfused blood products or decrease peri-operative blood loss. TRIAL REGISTRATION National Trial Register (NTR2975) and EudraCT (2011-002287-24).
A randomised controlled trial of fibrinogen concentrate during scoliosis surgery
Bleeding and blood transfusion are common after scoliosis surgery. Fibrinogen is essential for blood clot formation and depletes quickly during haemorrhage. We randomly allocated 102 children 12-18 years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30 mg.kg(-1) (maximum 2 g) and 51 to saline placebo. Fibrinogen reduced peri-operative blood loss by a median (95%CI) volume of 155 (5-320) ml, from a median (IQR [range]) of 1035 (818-1420 [400-3030]) ml to 885 (755-1155 [270-2645]) ml, p = 0.04. Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34. There were no side-effects.
Patients between 12 to 18 years old having surgery for idiopathic scoliosis (n= 102).
Intraoperative fibrinogen concentrate (30 mg.kg−1, maximum 2 g), (n= 51).
Saline placebo (n= 51).
Fibrinogen concentrate infusion reduced median perioperative bleeding by about 155ml compared with placebo. Fibrinogen did not reduce postoperative blood transfusion or increase postoperative haemoglobin concentration.
The Effect of Fibrinogen on Blood Loss After Lumbar Surgery: A Double-Blind Randomized Clinical Trial
Anesthesiology and pain medicine. 2019;9(3):e91199
Background: Spinal surgeries often have a high risk of hemorrhage during and after surgery, thus most patients require blood transfusions and blood products. Fibrinogen is used in different forms to control hemorrhage. Objectives: The present study aimed to evaluate the outcomes of prophylactic fibrinogen administration in reducing hemorrhage after lumbar surgery. Methods: This was a randomized clinical trial conducted on 30 patients undergoing lumbar surgery. The levels of fibrinogen, as well as hemoglobin (HB), hematocrit (HCT), prothrombin time (PT), partial thromboplastin time (PTT), and INR, were assessed preoperatively as the baseline values. The patients were divided into two groups: intervention (N = 15) and control (N = 15) groups. The intervention group received 1 g fibrinogen dissolved in 50 cc distilled water with surgical incision and the control group received 50 cc distilled water with the surgical incision. At the end of the operation, the volume of hemorrhage transfused blood products (fresh frozen plasma, packed cell, and platelet) was measured. In addition, at 0, 6, and 24 hours after the end of surgery and transfer to recovery, serum levels of fibrinogen, HB, HCT, INR, PT, PTT, and hemovac drain volume were measured. Results: The hemorrhage during and after the operation in the control group was significantly higher than that of the intervention group (P < 0.05). There were no significant differences between hemoglobin and serum level of fibrinogen before and after surgery between the two groups. The postoperative hypotension showed no significant difference between the two groups. Conclusions: The findings showed the effectiveness of fibrinogen in reducing acute hemorrhage. Considering the adverse consequences of hemorrhage and coagulopathy in patients undergoing surgery, using fibrinogen as prophylaxis is recommended in surgeries with high risks of hemorrhage.
Effects of colloid pre-loading on thromboelastography during elective intracranial tumor surgery in pediatric patients: hydroxyethyl starch 130/0.4 versus 5% human albumin
Bmc Anesthesiology. 2017;17((1)):62.
BACKGROUND Volume replacement therapy with colloid is still worth studying in major pediatric surgery with potential risk of bleeding. This study assessed the effects of 6% hydroxyethyl starch (HES) 130/0.4 and 5% Human Albumin (HA) on coagulation tested by thromboelastography (TEG) during elective intracranial tumor surgery in pediatric patients. METHODS In this randomized controlled trial, 60 patients undergoing intracranial tumor resection under general anesthesia were assigned to HES and HA groups (n = 30), and administered preloads of 20 mL . kg-1 HES 130/0.4 and 5% HA, respectively, prior to dura opening. Primary outcomes were perioperative thromboelastography findings, and hemodynamic and hematological parameters. Blood transfusion, perioperative fluid balance, intracranial pressure, mortality, intensive care unit stay, and hospital stay were also assessed. RESULTS TEG parameters did not differ after preloading compared to baseline values in either group, except for a decrease in maximum amplitude immediately after infusion (HES group, 57.6 +/- 6.0 mm vs. 50.9 +/- 9.2 mm; HA group, 60.1 +/- 7.9 mm vs. 56.6 +/- 7.1 mm; p < 0.01), which was restored to preoperative levels 1 h after fluid infusion. Total perioperative fluid balance, blood loss or transfusion, intracranial pressure, and hematological and hemodynamic variables were similar between both groups (p > 0.05). Mortality, length of hospital stay, and clinical complications were similar between both groups. CONCLUSION These findings suggest that HES and HA might have no significant differences regarding coagulation as assessed by TEG during pediatric intracranial tumor surgery with 20 ml/kg volume pre-loading, which can maintain stable hemodynamics and may represent a new avenue for volume therapy during brain tumor resection in pediatrics. TRIAL REGISTRATION ChiCTR-IPR- 16009333 , retrospectively registered October 8, 2016.
Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: a prospective randomised controlled trial
British Journal of Anaesthesia. 2015;115((2)):234-43.
BACKGROUND Hypofibrinogenaemia is one of the main reasons for development of perioperative coagulopathy during major paediatric surgery. The aim of this study was to assess whether prophylactic maintenance of higher fibrinogen concentrations through administration of fibrinogen concentrate would decrease the volume of transfused red blood cell (RBCs). METHODS In this prospective, randomised, clinical trial, patients aged 6 months to 17 yr undergoing craniosynostosis and scoliosis surgery received fibrinogen concentrate (30 mg kg(-1)) at two predefined intraoperative fibrinogen concentrations [ROTEM() FIBTEM maximum clot firmness (MCF) of <8 mm (conventional) or <13 mm (early substitution)]. Total volume of transfused RBCs was recorded over 24 h after start of surgery. RESULTS Thirty children who underwent craniosynostosis surgery and 19 children who underwent scoliosis surgery were treated per protocol. During craniosynostosis surgery, children in the early substitution group received significantly less RBCs (median, 28 ml kg(-1); IQR, 21 to 50 ml kg(-1)) compared with the conventional fibrinogen trigger of <8 mm (median, 56 ml kg(-1); IQR, 28 to 62 ml kg(-1)) (P=0.03). Calculated blood loss as per cent of estimated total blood volume decreased from a median of 160% (IQR, 110-190%) to a median of 90% (IQR, 78-110%) (P=0.017). No significant changes were observed in the scoliosis surgery population. No bleeding events requiring surgical intervention, postoperative transfusions of RBCs, or treatment-related adverse events were observed. CONCLUSIONS Intraoperative administration of fibrinogen concentrate using a FIBTEM MCF trigger level of <13 mm can be successfully used to significantly decrease bleeding, and transfusion requirements in the setting of craniosynostosis surgery, but not scoliosis. CLINICAL TRIAL REGISTRY NUMBER ClinicalTrials.gov NCT01487837.Copyright © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: email@example.com.
The effectiveness of rapidly infused intravenous fluids for inducing moderate hypothermia in neurosurgical patients
Anesthesia & Analgesia. 1999;89((1):):163-9.
UNLABELLED Moderate hypothermia is often used for cerebral protection during anesthesia for cerebral aneurysm clipping. No reliable, rapid, and practical noncardiopulmonary bypass methods for the induction of hypothermia to core temperatures <34 degrees C have been reported. We assessed the effects of IV administration of chilled 5% albumin (5 mL/kg at 1-6 degrees C) on core temperature after surface cooling to approximately 34 degrees C. We calculated thermal distribution volume from the change in core temperature after the chilled fluid infusions. We also compared rapid administration (5 mL/kg over 30 min) with very rapid administration (5 mL/kg over 3-5 min). Chilled albumin 5 mL/kg infused over 5 min reduced core temperature by 0.6+/-0.1 degrees C. The same volume of chilled albumin infused over 30 min reduced core temperature by 0.4+/-0.1 degrees C. The calculated thermal distribution volume was less than one third of total body volume. Because the thermal distribution volume in these hypothermic patients was much lower than total body volume, the chilled IV fluids in this study were 3 times more effective in inducing hypothermia than suggested by a simple calculation. To achieve maximal effectiveness, however, chilled fluids must be administered very rapidly (>100 mL/min) to avoid heat gains in standard IV tubing that occur even with rapid administration. IMPLICATIONS Chilled IV fluids can be much more effective for the induction of hypothermia than commonly assumed, but they must be administered very rapidly to avoid heat gains in IV tubing.