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1.
Effect of Perioperative Tranexamic Acid on Blood Loss following Open Simple Prostatectomy: A Prospective Review in Nigerian Men
Onyeze, C. I., Badmus, T. A., Salako, A. A., Owojuyigbe, A. M., Jeje, E. A., Olasehinde, O. O., Adeyemo, A., David, R. A.
West African journal of medicine. 2023;40(9):909-913
Abstract
BACKGROUND Haemorrhage is a common complication following open simple prostatectomy and patients may sometimes require a blood transfusion. Tranexamic acid has been shown to reduce blood loss following transurethral resection of the prostate and open radical prostatectomy. This study evaluated the effect of perioperative intravenous administration of tranexamic acid on blood loss and blood transfusion rates in patients who had OSP for benign prostatic enlargement. METHODOLOGY This was a comparative study of patients with documented prostate glands 60g and above scheduled for OSP. Initial hematocrit was done a day before surgery. The patients were randomized into a tranexamic acid group, which received perioperative intravenous tranexamic acid and the no-TXA group which received placebo (0.9% saline). All patients had open simple retropubic prostatectomy. Final post-operative hematocrit was assessed 72 hours after surgery, and blood loss was calculated using the modified Gross formula (actual blood loss = estimated blood volume x change in hematocrit / mean hematocrit). The transfusion rate was documented. RESULTS Fifty-six patients participated in this study and were randomized into a tranexamic acid group and no-tranexamic acid group. The mean age of patients in the tranexamic acid group was 66.07 ±7.08 years and was comparable to the no- tranexamic acid group which was 66.50 ± 8.80 years (P = 0.842). The median total blood loss was lower in the tranexamic acid group (502mls, IQR 613) compared to the no-tranexamic acid group (801mls, IQR 1069). The difference in the median blood loss between the two groups was 299mls (U 275, P 0.055). The rate of blood transfusion was lower in the tranexamic acid group (6 patients, 21%) compared to the no tranexamic acid group (11 patients, 39%), (P = 0.146). There was no difference in complication rates between the two groups. CONCLUSION The use of tranexamic acid in patients undergoing open simple prostatectomy showed a trend towards reduced intraoperative blood loss and less need no tranexamic for blood transfusion. This is of clinical significance, especially in elderly patients with low cardiovascular reserve.
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2.
The effect of tranexamic acid on perioperative blood loss in transurethral resection of the prostate: A double-blind, randomized controlled trial
Vanderbruggen, W., Brits, T., Tilborghs, S., Derickx, K., De Wachter, S.
The Prostate. 2023
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Editor's Choice
Abstract
BACKGROUND Bleeding and bleeding-related complications remain common after bipolar transurethral resection of the prostate (TURP) for benign prostatic hyperplasia. This may possibly lead to prolonged postoperative irrigation, catheterization, and hospital stay. The objective of this trial was to evaluate the effect of high-dose tranexamic acid (TXA) on perioperative blood loss in patients treated with bipolar TURP for prostate sizes between 30 and 80 g. METHODS We conducted a single-center, prospective, double-blind, randomized controlled trial. Eighty patients were screened for inclusion between March 2020 and January 2023. After exclusion, 65 patients were randomized in two comparable groups. The TXA group (31 patients) received a TXA intravenous loading dose of 10 mg/kg over 30 min before induction, followed by a maintenance dose of 5 mg/kg/h over 12 h. The placebo group (34 patients) received an equal dose of saline infusion. We measured age, weight, preoperative prostate size, anticoagulant use, 5-alpha reductase inhibitor use, preoperative urinary tract infection, American Society of Anesthesiologists score, difference in pre- and 24 h postoperative hemoglobin and hematocrit levels, operative time, resected adenoma weight, duration of postoperative irrigation, total amount of postoperative irrigation fluid, indwelling catheter time, duration of hospital stay, blood transfusion rate, and 4-week complication rate. RESULTS Baseline characteristics in both groups were comparable. Postoperative hemoglobin decrease in TXA versus placebo group was 1 versus 1.6 mg/dL, respectively (p = 0.04). In addition, the amount of postoperative irrigation fluid (10.7 vs. 18.5 L), irrigation time (24.3 vs. 37.9 h), catheterization time (40.8 vs. 53.7 h), and hospital stay (46.9 vs. 59.2 h) were statistically significant in favor of TXA use. No blood transfusions were carried out. Four-week complication rate was comparable between the two groups. CONCLUSIONS Perioperative high-dose TXA seems beneficial in reducing hemoglobin loss, postoperative irrigation, catheterization time, and hospital stay in bipolar TURP for prostate sizes between 30 and 80 g, without increased risk of TXA-related thromboembolic events.
PICO Summary
Population
Patients treated with bipolar transurethral resection of the prostate (n= 65).
Intervention
Tranexamic acid (TXA), (n= 31).
Comparison
Placebo (saline infusion), (n= 34).
Outcome
Postoperative haemoglobin decrease in TXA compared to placebo was 1 versus 1.6 mg/dL, respectively. The amount of postoperative irrigation fluid (10.7 vs. 18.5 L), irrigation time (24.3 vs. 37.9 h), catheterization time (40.8 vs. 53.7 h), and hospital stay (46.9 vs. 59.2 h) were statistically significant in favor of TXA use. No blood transfusions were carried out. Four-week complication rate was comparable between the two groups.
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Evaluating the effectiveness of tranexamic acid administration in reducing bleeding in benign prostate hyperplasia patients underwent open prostatectomy: A double-blind randomized clinical trial
Mohammadi Sichani M, Mohammadi S, Khorrami MH, Zargham M, Javid A, Dehghani M, Gholipour F, Dehkordi PR, Kazemi R
Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences. 2023;28:8
Abstract
BACKGROUND Blood loss of postoperative after prostate surgery could be related with an increase in urinary fibrinolytic activity. Tranexamic acid (TXA) is both a potent inhibitor of plasminogen and urokinase activators and a low molecular weight substance that is excreted unchanged in the urinary tract and can be administered both orally and intravenously. This study aimed to evaluate the effectiveness TXA administration in reducing bleeding in benign prostatic hyperplasia (BPH) patients who underwent open prostatectomy. MATERIALS AND METHODS This double-blind randomized clinical trial was conducted on patients with BPH who underwent open prostatectomy. The first group received TXA (1 gr IV from during surgery to 48 h after surgery, 3 times/day). Twenty-four hours after surgery, the two groups were compared in terms of bleeding rate. Hemoglobin (Hb), hematocrit (HCT), and platelet (Plt) counts were also assessed before and after the intervention. RESULTS Intervention and control groups were comparable in terms of basic and baseline values of variables at the beginning of the study (P > 0.05). The mean bleeding volume in TXA group was significantly lower than the control group 112.11 ± 53.5 and 190.00 ± 97.5 CC; P ≤ 0.001). Mean hospitalization (3.28±0.46 vs. 4.38 ± 0.95 days P < 0.001) and surgery duration (98.11 ± 37.11 vs. 128.00 ± 39.12 h; P = 0.001) were significantly lower in TXA group compared to control intervention. CONCLUSION According to the findings of the current study, the administration of TXA led to reduce bleeding in BPH patients who underwent open prostatectomy. Furthermore, the mean Hb, HCT, levels were significantly affected by TXA. TXA treatment approach also can reduce the surgery and hospitalization time effectively. TXA approach is recommended as effective procedure in BPH patients who underwent open prostatectomy.
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Tranexamic Acid Does Not Improve Outcomes of Holmium Laser Enucleation of the Prostate (HoLEP): A Prospective Randomized, Controlled Trial
Assmus MA, Lee MS, Helon JW, Krambeck A
Journal of endourology. 2022
Abstract
INTRODUCTION Tranexamic acid (TXA) is a clot promoting agent utilized during orthopedic procedures to decrease bleeding. Urologists have demonstrated benefits of TXA in percutaneous surgery. Our objective was to assess safety and efficacy of single-dose TXA on same-day HoLEP outcomes. METHODS From September 2021 to January 2022, we prospectively randomized 110 patients undergoing HoLEP to either 1 gram of TXA after induction or no treatment. IRB approval (STU00215134) and registry with ClinicalTrials.gov (NCT05082142) was obtained prior to enrollment. Primary outcome was rate of successful same day discharge (SDD). Secondary outcomes included transfusion rate, same day catheter removal, length of stay (LOS), and 90-day complications. Power analysis determined 110 patients should be enrolled to detect a 25% difference in SDD rate. RESULTS There was no difference in patient demographic and prostate features between control (n=55) and TXA groups (n=55) (all p>0.05). The overall rate of successful SDD was not different between control and TXA groups (49/55 (89%) vs. 51/55 (93%), p=0.74). Median LOS (hh:mm) was not different between groups (03:07 vs. 02:50, p=0.23) with only 3/110 (2.7%) having a LOS >24hours. Successful same day catheter removal occurred in 99/110 (90%) patients with no difference between groups (49/55 vs. 50/55, p=0.99). There was no difference in operative parameters (time, energy, specimen weight) and postoperative complications between groups (all p>0.05). No patients required transfusions and there were no major 90-day complications related to surgery (Clavien-dindo ≥IIIb). CONCLUSION TXA administration is safe but did not impact same day discharge after HoLEP.
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Can tranexamic acid in irrigation fluid reduce blood loss during monopolar transurethral resection of the prostate? A randomised controlled trial
Tawfick A, Mousa W, El-Zhary AF, Saafan AM
Arab journal of urology. 2022;20(2):94-99
Abstract
OBJECTIVE To assess the efficacity and safety of using tranexamic acid (TXA) in the irrigation solution during transurethral resection of the prostate (TURP). PATIENTS AND METHODS A total of 50 patients undergoing TURP for benign prostatic hyperplasia were prospectively randomised in a controlled clinical trial and distributed into two groups. Group A received 0.1% TXA 1000 mg (10 mL) in 1 L of irrigation solution of sterile wash (glycine) during surgery, while Group B received 10 mL distilled water (placebo) in 1 L of irrigation solution of sterile wash (glycine) during surgery. At the end of surgery, a three-way catheter was inserted in the bladder. Group A received local 500 mg of TXA (5 mL), which was dissolved in 100 mL of normal saline solution, while Group B received distilled water (5 mL) dissolved in 100 mL of normal saline solution after which the catheter was clamped. The serum haemoglobin (Hb) concentration, haematocrit (HCT), blood loss volume, Hb concentration in the irrigation fluid, and bladder irrigation volumes were compared between the two groups at three time-points: preoperatively and at 4- and 24-h postoperatively. Coagulation function, complications, thromboembolic events, quality of endoscopic view, surgery duration, and hospital stay were also noted. RESULTS Group A had significantly lower blood loss intraoperatively, and at 4- and 24-h postoperatively compared to the control group (P < 0.05). The serum Hb concentration, HCT, Hb concentration in the irrigation fluid, and bladder irrigation volumes were significantly lower in the TXA group vs the control group (P < 0.001). The shortening of the surgery duration and improvement in the quality of the endoscopic view were significantly noted in the TXA group (P = 0.001). However, no thromboembolic events occurred in either group. CONCLUSION The use of TXA in the irrigation fluid during TURP and injection into the bladder postoperatively can reduce blood loss and the need for blood transfusion without increasing the risk of thrombosis.
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Can high-dose tranexamic acid have a role during transurethral resection of the prostate in large prostates? A randomised controlled trial
Samir M, Saafan AM, Afifi RM, Tawfick A
Arab journal of urology. 2022;20(1):24-29
Abstract
OBJECTIVES To assess the efficacy and safety of high-dose tranexamic acid (TXA) during bipolar transurethral resection of the prostate (B-TURP) in patients with large prostates compared to placebo. PATIENTS AND METHODS From February 2018 to May 2020, 204 patients with enlarged prostates of 80-130 g and in need of surgical intervention were randomised into two groups. Patients in Group A underwent B-TURP and received TXA as an intravenous loading dose of 50 mg/kg over 20 min before induction of anaesthesia followed by a maintenance infusion of 5 mg/kg/h until resection was completed. The patients in Group B (placebo) received a saline infusion of a similar volume. RESULTS There was highly significant drop in haemoglobin in the placebo group at 4- and 24-h postoperatively compared with the TXA group (P < 0.001). However, there was no significant difference in the blood transfusion rate between the two groups with five patients (5.5%) in the placebo group and four (4.2%) in the TXA group requiring a transfusion (P = 0.74). The procedural time was significantly less in the TXA group vs the control group, at a mean (SD) of 79.93 (22.18) vs 90.91 (21.4) min (P = 0.001). Also, the intraoperative irrigation fluid volume and postoperative irrigation duration were significantly less in the TXA group vs the control group, at a mean (SD) of 19.21 (3.13) vs 23.05 (3.8) L and 14.75 (5.15) vs 18.33 (5.96) h, respectively (P = 0.001). Catheterisation and hospital stay durations were comparable between both groups (P = 0.384 and P = 0.388, respectively). No complications were recorded with use of high-dose TXA. CONCLUSION High-dose TXA was effective in controlling blood loss during B-TURP in patients with large prostates, with no adverse drug reactions.
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Efficacy of tranexamic acid in decreasing primary hemorrhage in transurethral resection of the prostate: A novel combination of intravenous and topical approach
Gupta A, Priyadarshi S, Vyas N, Sharma G
Urology annals. 2021;13(3):238-242
Abstract
BACKGROUND Transurethral resection of the prostate (TURP) is the gold standard for benign prostatic enlargement; however, hemorrhage still remains one of the major complications. OBJECTIVE The primary aim of this study was to evaluate the effect of tranexamic acid (TXA) in reducing intraoperative blood loss and need for blood transfusion. Secondary parameters compared were operating time, volume of irrigation fluid used, and reduction in hemoglobin concentration. SUBJECTS AND METHODS A total of 70 eligible patients undergoing TURP were randomized based on computer generated table into two groups. The study group (1) received IV TXA 500 mg after induction of anesthesia and 500 mg in each irrigation fluid bottle (dual mode) and the control group (2) received none. RESULTS The mean age (68.20 vs. 66.5 years), prostate size (57 vs. 51 g), and preoperative hemoglobin (13.3 vs. 13.5 g/dl) were similar between the groups. Intraoperative blood loss in the TXA group was found to be significantly reduced (174.60 ± 125.38 ml vs. 232.47 ± 116.8; P = 0.04). Blood transfusion was required in 2.8% of cases as compared to 14.2% in controls. Operating time, volume of irrigation fluid, and postoperative reduction of hemoglobin were not significant between the groups. No complications were observed in both groups. CONCLUSION In this study, we observed that TXA, when used as a combination of Intravenous and topical route, effectively reduced intra-operative blood loss and the need for transfusion.
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Safety and Efficacy of Using Tranexamic Acid at the Beginning of Robotic-Assisted Radical Prostatectomy in a Double-Blind Prospective Randomized Pilot Study
Balík, M., Košina, J., Hušek, P., Broďák, M., Čečka, F.
Acta Medica (Hradec Kralove). 2020;63(4):176-182
Abstract
BACKGROUND The prophylactic administration of tranexamic acid has been shown to be appropriate for procedures with a high risk of perioperative bleeding in cardiac surgery and orthopaedics. In urology the ambiguous results have been reported. Our goal was to evaluate the effect of tranexamic acid administration in robotic-assisted radical prostatectomy (RARP). A pilot, prospective, double-blind, randomized study was conducted to evaluate this effect. METHODS The study included 100 patients who received RARP in the period from April 2017 to January 2018. The patients were randomly assigned to study and control groups of 50 patients each. RESULTS The median follow-up was 6 months. Lower haemoglobin level drop weighted for gram of operated prostate was observed in the study group when treating the dorsal vein complex (DVC) at the beginning of the procedure (p = 0.004 after 3 hours and p < 0.001 after 24 hours). There was no evidence of any serious side effect of tranexamic acid. CONCLUSION We demonstrated the safety of tranexamic acid at RARP. In addition, we showed that administration of tranexamic acid at the beginning of RARP significantly reduces the decrease in haemoglobin after the procedure when treating the DVC at the beginning of the procedure.
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Tranexamic acid is beneficial for reducing perioperative blood loss in transurethral resection of the prostate
Meng QQ, Pan N, Xiong JY, Liu N
Experimental and therapeutic medicine. 2019;17(1):943-947
Abstract
The aim of this randomized controlled trial was to evaluate the effect of tranexamic acid (TXA) on postoperative blood loss during transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH). A total of 60 patients with BPH and undergoing TURP were randomized into TXA and control groups. Patients were intravenously administered 1 g TXA or placebo (0.9% sodium chloride solution), respectively, after the induction of anesthesia for TURP. Intraoperative and postoperative bladder irrigation volumes and blood loss volumes were compared between the two groups. Coagulation function (measured by prothrombin, activated partial thromboplastin and thrombin time and fibrinogen levels) was measured before the operation and at 4 h post-operation. Complications from thromboembolic events, such as lower-limb and pulmonary embolisms, were also noted. The TXA group had significantly decreased blood loss intraoperatively and at 4 h postoperatively compared with the control group (P<0.05). The 24 h postoperative blood loss and coagulation function of the two groups were not significantly different. No thromboembolic events or other complications occurred in either group. In conclusion, a preoperative single dose of TXA was indicated to reduce perioperative blood loss in TURP without a notable increase in thrombosis risk.
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Safety and efficacy of intravenous tranexamic acid in endoscopic transurethral resections in urology: Prospective randomized trial
Jendoubi A, Malouch A, Bouzouita A, Riahi Y, Necib H, Ghedira S, Houissa M
Progres En Urologie : Journal De L'association Francaise D'urologie Et De La Societe Francaise D'urologie. 2017;27((16):):1036-1042
Abstract
BACKGROUND Endoscopic urological procedures (transurethral resection of the prostate TURP/transurethral resection of bladder tumor TURBT) are not without risk of significant bleeding. This risk is due to the vascular nature of the tissues and their high levels of fibrinolytic enzymes in the tissues and urine. This study was conducted to evaluate the safety and efficacy of the antifibrinolytic agent tranexamic acid (TXA) in reducing blood loss in patients undergoing TURP/TURBT and transfusion requirement. METHODS This study was a prospective, randomized, double-blind, placebo controlled clinical trial. One hundred and thirty-one patients of ASA physical status I or II, undergoing TURP (60 patients) or TURBT (71 patients) were randomly allocated to receive IV TXA bolus of 10mg/kg at the induction of anesthesia followed by infusion of 1mg/kg/h intraoperatively and for 24h postoperatively or an equal volume of saline (control group). Blood loss was evaluated in terms of reduction in the serum hemoglobin level (delta Hb=Hb H24-Hb H0). RESULTS There was no difference between two groups in terms of transfusion requirements and episodes of retention. TXA did not significantly reduce mean blood loss compared with placebo during TURP (1.37+/-0.69 vs. 1.72+/-1.23g/dL respectively, P=0.256) or TURBT (1.15+/-0.95 vs. 1.07+/-0.88g/dL; P=0.532). No thrombotic complications were noted in any patient. CONCLUSION Tranexamic acid did not reduce transfusion requirements or perioperative blood loss in transurethral resection of the prostate or bladder tumor. LEVEL OF EVIDENCE 4.