1.Efficacy and safety of antifibrinolytic agents in spinal surgery: a network meta-analysis.
Lei YUAN ; Yan ZENG ; Zhong-Qiang CHEN ; Xin-Ling ZHANG ; Shuo MAI ; Pan SONG ; Li-Yuan TAO
Chinese Medical Journal 2019;132(5):577-588
BACKGROUND:
Significant blood loss is still one of the most frequent complications in spinal surgery, which often necessitates blood transfusion. Massive perioperative blood loss and blood transfusion can create additional risks. Aprotinin, tranexamic acid (TXA), and epsilon-aminocaproic acid (EACA) are antifibrinolytics currently offered as prophylactic agents to reduce surgery-associated blood loss. The aim of this study was to evaluate the efficacy and safety of aprotinin, EACA, and low/high doses of TXA in spinal surgery, and assess the use of which agent is the most optimal intervention using the network meta-analysis (NMA) method.
METHODS:
Five electronic databases were searched, including PubMed, Cochrane Library, ScienceDirect, Embase, and Web of Science, from the inception to March 1, 2018. Trials that were randomized and compared results between TXA, EACA, and placebo were identified. The NMA was conducted with software R 3.3.2 and STATA 14.0.
RESULTS:
Thirty randomized controlled trial (RCT) studies were analyzed. Aprotinin (standardized mean difference [SMD]=-0.65, 95% credibility intervals [CrI;-1.25, -0.06]), low-dose TXA (SMD = -0.58, 95% CrI [-0.92, -0.25]), and high-dose TXA (SMD = -0.70, 95% CrI [-1.04, -0.36]) were more effective than the respective placebos in reducing intraoperative blood loss. Low-dose TXA (SMD = -1.90, 95% CrI [-3.32, -0.48]) and high-dose TXA (SMD = -2.31, 95% CrI [-3.75, -0.87]) had less postoperative blood loss. Low-dose TXA (SMD = -1.07, 95% CrI [-1.82, -0.31]) and high-dose TXA (SMD = -1.07, 95% CrI [-1.82, -0.31]) significantly reduced total blood loss. However, only high-dose TXA (SMD = -2.07, 95% CrI [-3.26, -0.87]) was more effective in reducing the amount of transfusion, and was significantly superior to low-dose TXA in this regard (SMD = -1.67, 95% CrI [-3.20, -0.13]). Furthermore, aprotinin (odds ratio [OR] = 0.16, 95% CrI [0.05, 0.54]), EACA (OR = 0.46, 95% CrI [0.22, 0.97]) and high dose of TXA (OR = 0.34, 95% CrI [0.19, 0.58]) had a significant reduction in transfusion rates. Antifibrinolytics did not show a significantly increased risk of postoperative thrombosis. Results of ranking probabilities indicated that high-dose TXA had the greatest efficacy and a relatively high safety level.
CONCLUSIONS
The antifibrinolytic agents are able to reduce perioperative blood loss and transfusion requirement during spine surgery. And the high-dose TXA administration might be used as the optimal treatment to reduce blood loss and transfusion.
Aminocaproic Acid
;
therapeutic use
;
Antifibrinolytic Agents
;
therapeutic use
;
Aprotinin
;
therapeutic use
;
Humans
;
Randomized Controlled Trials as Topic
;
Spine
;
surgery
;
Tranexamic Acid
;
therapeutic use
2.Application of Tranexamic Acid in Shoulder Arthroscopic Surgery: A Randomised Controlled Trial.
Tian-Ci WANG ; Jia-Liang GUO ; Qiu-Ping TIAN ; He-Ping DENG ; Bing YIN ; Zeng XIAO ; Bo LU
Chinese Medical Sciences Journal 2023;38(4):273-278
Objective To explore the optimal administration route of tranexamic acid (TXA) in shoulder arthroscopic surgery. Methods Patients undergoing arthroscopic rotator cuff repair were randomly divided into four groups: control group (without TXA treatment), intravenous group (TXA was intravenously administered 10 minutes before surgery), irrigation group (TXA was added to the irrigation fluid during subacromial decompression and acromioplasty), and intravenous plus irrigation group (TXA was applied both intravenously and via intra-articular irrigation). The primary outcome was visual clarity assessed with visual analog scale (VAS) score, and the secondary outcomes included irrigation fluid consumption and time to subacromial decompression and acromioplasty procedure. Results There were 134 patients enrolled in the study, including 33 in the control group, 35 in the intravenous group, 32 in the irrigation group, and 34 in the intravenous plus irrigation group. The median and interquartile range of VAS scores for the intravenous, irrigation, and intravenous plus irrigation groups were 2.70 (2.50, 2.86) (Z = -3.677, P = 0.002), 2.67 (2.50, 2.77) (Z = -3.058, P < 0.001), and 2.91 (2.75, 3.00) (Z = -6.634, P < 0.001), respectively, significantly higher than that of the control group [2.44 (2.37, 2.53)]. Moreover, the control group consumed more irrigation fluid than the intravenous group, irrigation group, and intravenous plus irrigation group (all P < 0.05). The intravenous plus irrigation group consumed less irrigation fluid than either the intravenous group or the irrigation group (both P < 0.001). There was no difference in subacromial decompression and acromioplasty operative time among the four groups. Conclusion TXA applied both topically and systematically can improve intraoperative visual clarity, and the combined application is more effective.
Humans
;
Tranexamic Acid/therapeutic use*
;
Shoulder
;
Arthroscopy/methods*
;
Decompression, Surgical/methods*
;
Treatment Outcome
4.Hemostatic efficacy of tranexamic acid and ε-aminocaproic acid in hip and knee arthroplasty:a Meta-analysis.
China Journal of Orthopaedics and Traumatology 2022;35(5):484-490
OBJECTIVE:
To systematically evaluate the hemostatic efficacy of tranexamic acid and ε-aminocaproic acid in total hip arthroplasty (THA) and total knee arthroplasty (TKA).
METHODS:
Randomized controlled trials (RCT) and retrospective case-control studies about tranexamic acid and ε-aminocaproic acid for the comparison of THA or TKA were searched electronically in PubMed, EMbase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang, VIP from the time of building databases to July 2020. Two investigators carried out literature screening and data extraction according to the inclusion and exclusion criteria respectively. The methodological quality of the included randomized controlled studies was evaluated through the Cochrane Handbook, and the methodological quality of the included retrospective case-control studies was evaluated through the NOS scale. Blood loss, the incidence of thrombosis complications, per capita input of hemoglobin were Meta-analyzed by Review Manager 5.3 software.
RESULTS:
A total of 6 articles were included, including 4 RCTs and 2 retrospective case-control studies. A total of 3 174 patients, including 1 353 in the tranexamic acid group and 1 821 in the ε-aminocaproic acid group. Meta-analysis results showed that there were no difference statistical significance in blood loss [MD=-88.60, 95%CI(-260.30, 83.10), P=0.31], blood transfusion rate [OR=1.48, 95%CI(0.96, 2.27), P=0.08], thrombotic complications [OR=0.80, 95%CI(0.07, 8.83), P=0.85], per capita hemoglobin input [MD=0.04, 95%CI(-0.02, 0.10), P=0.18] between tranexamic acid group and ε-aminocaproic acid group during THA. While in TKA, the blood loss of the tranexamic acid group was less than that of the ε-aminocaproic acid group [MD=-147.13, 95%CI(-216.52, -77.74), P<0.0001], the difference was statistically significant. The blood transfusion rate [OR=1.30, 95%CI(0.74, 2.28), P=0.37], thrombotic complications [OR=0.95, 95%CI(0.38, 2.36), P=0.92], per capita hemoglobin input [MD=-0.00, 95%CI(-0.05, 0.06), P=0.48], tourniquet time [MD=1.54, 95%CI(-2.07, 5.14), P=0.40] were similar between two groups, the difference was not statistically significant.
CONCLUSION
In THA, tranexamic acid and ε-aminocaproic acid have similar hemostatic effects, while in TKA, tranexamic acid can effectively reduce the patient's blood loss and has a better hemostatic effect. Tranexamic acid is recommended as one of the first choice hemostatic drugs for TKA.
Aminocaproic Acid/therapeutic use*
;
Antifibrinolytic Agents/therapeutic use*
;
Arthroplasty, Replacement, Hip/methods*
;
Arthroplasty, Replacement, Knee/methods*
;
Blood Loss, Surgical/prevention & control*
;
Hemoglobins
;
Hemostatics
;
Humans
;
Tranexamic Acid/therapeutic use*
5.Application of tranexamic acid in the treatment of intertrochanteric fracture of femur.
Jun-An LIN ; Hai-Dong CUI ; Ye HONG ; Shu-Jun LYU
China Journal of Orthopaedics and Traumatology 2021;34(7):601-604
OBJECTIVE:
To investigate the application of tranexamic acid in the treatment of intertrochanteric fracture.
METHODS:
From January 2017 to October 2019, 100 patients with intertrochanteric fracture were randomly divided into observation group (48 cases) and control group(52 cases). All patients received the same surgical treatment. The control group was given tranexamic acid 20 minutes before operation, and 15 mg/kg diluted in 250 ml sodium chloride injection, intravenous drip;the observation group was given tranexamic acid 0.5 g dissolved in 20 ml normal saline injected into femoral bone marrow cavity for local treatment on the basis of the control group. The blood loss, operation time and postoperative hospital stay were compared between two groups. Hematocrit, hemoglobin, D-dimer and fibrinogen levels were analyzed before and after operation, and the incidence of thrombotic complications was observed.
RESULTS:
The total blood loss, dominant blood loss, hidden blood loss and postoperative drainage volume of the observation group were significantly lower than those of the control group (
CONCLUSION
Tranexamic acid combined with systemic and local application has important clinical significance in reducing perioperative blood lossand blood cell loss in patients with intertrochanteric fracture, and has good safety.
Antifibrinolytic Agents/therapeutic use*
;
Blood Loss, Surgical
;
Femur
;
Hip Fractures/surgery*
;
Humans
;
Postoperative Hemorrhage
;
Tranexamic Acid
;
Treatment Outcome
6.Local application of tranexamic acid reduces blood less in unilateral total knee arthroplasty: a retrospective comparison analysis.
Yun-qing MA ; Yi-chao ZHANG ; Hong ZHANG
Chinese Journal of Surgery 2013;51(1):40-43
OBJECTIVETo investigate the efficacy and safety of tranexamic acid in patients who receiving unilateral total knee arthroplasty (TKA).
METHODSFrom March 2011 to March 2012, clinical data of 95 patients who received primary unilateral TKA were analyzed retrospectively, including 23 male and 72 female patients, age from 60 to 87 years, mean (71 ± 4) years. The patients in treatment group received 0.5 g of tranexamic acid inside knee joint after capsule closure, and patients in control group did not receive tranexamic acid. Two groups of patient's age, height, weight and disease diagnosis and other parameters of the differences were no statistical significance (P > 0.05). The amounts of intraoperative blood loss, postoperative visible blood loss, the hidden blood loss, and blood transfusion, the number of patients needing blood transfusion, symptoms of deep venous thrombosis and lower extremity ecchymosis were observed. The values of preoperative and 3 hours of postoperative D-dimer and related coagulation markers were recorded. Group t test was used to compare between the two groups.
RESULTSThere were no significant differences in intraoperative blood loss (P > 0.05). The amounts of postoperative visible blood loss, the hidden blood loss was significant different (t = 17.51 and 64.18, P < 0.05). Transfusion of both groups were (470 ± 150) ml and (708 ± 245) ml. The value of postoperative hemoglobin and hematocrit was lower in control group as compared with those in treatment group (t = -18.88 and -13.05, P < 0.05). No deep venous thrombosis was observed through Doppler ultrasound examination. Postoperative 3 hours D-dimer in the two groups for (0.91 ± 0.44) and (1.21 ± 0.65) mg/L, were significantly higher than that of preoperative (0.36 ± 0.11) and (0.37 ± 0.14) mg/L, with a statistically significant difference (t = 5.40 and 44.68, P < 0.05), and the control group was higher than treatment group (t = 1.99, P < 0.05). There was not statistically significant difference between the coagulation indicators of the two groups.
CONCLUSIONSThe local application of tranexamic acid intraoperatively in unilateral TKA patients could significantly reduce the amounts of postoperative blood loss and blood transfusion to avoid TKA patients' perioperative anemia-related complications. It is also safe, ecnomic and easy to use during surgery.
Aged ; Aged, 80 and over ; Antifibrinolytic Agents ; therapeutic use ; Arthroplasty, Replacement, Knee ; Female ; Humans ; Male ; Middle Aged ; Postoperative Hemorrhage ; prevention & control ; Retrospective Studies ; Tranexamic Acid ; therapeutic use ; Treatment Outcome
7.Effects of oral and intravenous tranexamic acid on perioperative blood loss after lumbar spinal canal decompression and fusion.
Mei-Tao QI ; Shu-Ying WANG ; Ling-Ting WANG ; Xue-Wu CHEN ; Wen-Hao ZHAN ; Xiao-Feng ZHU ; Hong WANG
China Journal of Orthopaedics and Traumatology 2022;35(8):736-739
OBJECTIVE:
To explore the effects of different administration methods of tranexamic acid(TXA) on the perioperative blood loss, hidden blood loss, transfusion rate and adverse reactions in lumbar spinal decompression and fusion.
METHODS:
Sixty patients who received lumbar spinal canal decompression and fusion from July 2019 to July 2020 were enrolled and divided into observation group and control group, with 30 cases in each group. The observation group was given 2 g TXA orally at 2 hours before operation, control group was given 1 g TXA for 5-10 min before skin incision and 6 hours after operation intravenously. The intraoperative blood loss, postoperative drainage, total blood loss, hidden blood loss, drainage tube removal time, blood transfusion rate, venous thrombosis rate, adverse event rate were recorded respectively. The changes of hemoglobin(Hb) and hematocrit (HCT) were observed before operation and 1, 3 days after operation.
RESULTS:
Hb and HCT at 1 and 3 days after operation were significantly improved compared with those before operation(P<0.01). However, there was no significant difference between the groups(P>0.05). There were no significant difference in amount of blood loss, postoperative drainage, total blood loss, intraoperative blood loss, hidden blood loss, postoperative drainage time, and blood transfusion rate between two groups (P>0.05). There were no venous thrombosis and adverse events occurred in both groups.
CONCLUSION
During the perioperative period of lumbar spinal decompression and fusion, oral TXA and intravenous TXA have the same effect in reducing perioperative blood loss and are safe and reliable. It is recommended that oral TXA be used to save medical costs and convenience.
Antifibrinolytic Agents/therapeutic use*
;
Blood Loss, Surgical/prevention & control*
;
Decompression
;
Humans
;
Postoperative Hemorrhage
;
Spinal Canal
;
Spinal Fusion/methods*
;
Tranexamic Acid/therapeutic use*
;
Venous Thrombosis/etiology*
8.Effectiveness and safety of tranexamic acid in patients receiving on-pump coronary artery bypass grafting without clopidogrel and aspirin cessation.
Jia SHI ; Yue-Fu WANG ; Qing-Hua XUE ; Su YUAN ; Gu-Yan WANG ; Li-Huan LI
Chinese Journal of Surgery 2013;51(6):527-532
OBJECTIVETo evaluate the effectiveness and safty of tranexamic acid in patients receiving on-pump coronary artery bypass grafting (CABG) without clopidogrel and aspirin cessation.
METHODSThe current study is a prospective, randomized and placebo-control trial. A total of 116 patients receiving selective on-pump CABG with their last ingestion of clopidogrle and aspirin within 7 days preoperatively were recruited. Despite 6 patients withdrawal their consent, the rest 110 were randomized to receive tranexamic acid or placebo. The tranexamic acid regimen was a bolus of 10 mg/kg followed by a maintenance of 10 mg·kg(-1)·h(-1) throughout the surgery. The primary outcome was the volume of allogeneic erythrocyte transfused perioperatively.
RESULTSBaseline characteristics were comparable between the groups. In patients receiving tranexamic acid and placebo respectively, the volume of allogeneic erythrocyte transfused was 4.0 (7.5) units and 6.0(6.0) units (W = 1021, P < 0.01). In these 2 groups respectively, blood loss was 930 (750) ml and 1210 (910) ml (W = 1042, P < 0.01), the incidence of major bleeding was 50.9% and 76.4% (χ(2) = 7.70, P < 0.01), the incidence of reoperation was 0 and 9.1% (χ(2) = 5.24, P = 0.02); the volume of plasma transfused was 400 (600) ml and 600 (650) ml (W = 1072, P = 0.01), the exposure of plasma was 60.0% and 85.5% (χ(2) = 8.98, P < 0.01) and the exposure to any allogeneic blood products was 85.5% and 98.2% (χ(2) = 5.93, P = 0.01). Perioperative mortality, morbidity and the incidence of adverse events were balanced between the groups without statistical significance.
CONCLUSIONTranexamic acid reduced significantly postoperative bleeding and transfusion in patients receiving on-pump CABG without clopidogrel and aspirin cessation.
Aged ; Aged, 80 and over ; Aspirin ; therapeutic use ; Blood Transfusion ; Coronary Artery Bypass ; Female ; Humans ; Male ; Middle Aged ; Postoperative Hemorrhage ; prevention & control ; Prospective Studies ; Ticlopidine ; analogs & derivatives ; therapeutic use ; Tranexamic Acid ; adverse effects ; therapeutic use
9.Acute Myocardial Infarction After Tranexamic Acid: Review of Published Case Reports.
Yun Tai YAO ; Xin YUAN ; Ken SHAO
Chinese Medical Sciences Journal 2020;35(1):65-70
Objective To summarize cases of acute myocardial infarction (AMI) after tranexamic acid (TXA) administration. Methods Electronic databases were searched to identify all case reports presenting AMI after use of TXA. Two authors independently extracted data of patients' manifestation, examinations, medical history, treatment and outcome. Results Our search yielded seven case reports including seven patients. Among the seven reports, two were from USA, and the other five were from India, Turkey, UK, Italy and France, respectively. Of the seven patients aged between 28- and 77-year-old who developed AMI after TXA, five patients were female and two were male. TXA was prescribed for four patients to reduce surgical bleeding, for two patients to treat menorrhagia and for one patient to manage hemoptysis. The diagnosis of AMI was made based upon patients' symptoms, ECG, myocardium-specific enzymes, and confirmed by coronary angiography. Coronary stents were placed in four patients, for whom anti-platelet and anti-coagulation drugs were prescribed. No death or major cardiovascular events were reported during hospitalization and follow-up. Conclusion These case reports suggested a possible association of TXA administration and an increased risk of AMI, even in patients with relatively low thrombotic risk.
Adult
;
Aged
;
Blood Loss, Surgical/prevention & control*
;
Female
;
Humans
;
Male
;
Middle Aged
;
Myocardial Infarction/diagnosis*
;
Risk Factors
;
Tranexamic Acid/therapeutic use*
10.Efficacy and safety of multiple-dose intravenous tranexamic acid for reducing blood loss in complex tibial plateau fractures: A prospective randomized controlled trial.
Weiguo BAO ; Jiangang ZHOU ; Yong WANG ; Jifeng WANG ; Miao CHU
Chinese Journal of Reparative and Reconstructive Surgery 2023;37(9):1055-1061
OBJECTIVE:
To investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial.
METHODS:
A study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference ( P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion.
RESULTS:
① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups ( P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant ( P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant ( P>0.05). There was no significant difference in the operation time between groups ( P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups ( P<0.05); there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant ( P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups ( P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups ( P>0.05), while there was a significant difference in IL-6 between groups ( P<0.05).
CONCLUSION
Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
Humans
;
Tranexamic Acid/therapeutic use*
;
Blood Loss, Surgical/prevention & control*
;
Interleukin-6
;
Prospective Studies
;
Tibial Plateau Fractures
;
Tibial Fractures/surgery*
;
Thrombosis