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Transmine 1. Tranexamic acid (Tansamine) (antifibrinolytic agent) Transamine Transamine 2. Transmine 0.5 1g( 10 15mg/kg 2-3 ) 1-1.5g 3-4 LD50(50% ) 18 transmine dose 1-2 loading 2g Transmine 3. Transamine Transamine 4. Transamine Transamine Transmine Tranexamic acid Med-line Tranexamic acid, hemorrhage, thrombosis key word 1. Acta-Orthop-Scand. 2000 Jun; 71(3): 250-4 Tranexamic acid, given at the end of the operation, does not reduce postoperative blood loss in hip arthroplasty. Benoni,-G; Lethagen,-S; Nilsson,-P; Fredin,-H --- We performed a randomized double-blind study on the effect of tranexamic acid on postoperative blood loss and blood transfusions in 39 primary THR operations. Tranexamic acid was given at the end of the operation and 3 hours later. Ultrasound examination 1 week later was performed to measure the occurrence of deep hematomas. In contrast to previous findings in knee arthroplasty, the administration of tranexamic acid failed to give a significant reduction in the postoperative blood loss. This lack of effect was possibly related to the fact that the drug was administered too late. In 11 of the 20 patients receiving tranexamic acid, blood transfusion was not necessary, this being the case in 4/19 in the placebo group (p = 0.05). The occurrence of postoperative deep venous thromboses was similar in the tranexamic acid and placebo groups. 2. Anesth.Analg.2000 Nov;91(5):1124-30 Tranexamic acid reduces blood loss in total hip replacement surgery Ekback,G.; Axelsson,K.; Ryttberg,L.; Edlund,B.; Kjellberg,J.; Weckstrom,J.; Carlsson,O.; Schott,U. --- Intraoperatively administered, tranexamic acid (TA) does not reduce bleeding in total hip replacement (THR). Therefore, its prophylactic use was attempted in the present study because this has been shown to be more effective in cardiac surgery. We investigated 40 patients undergoing THR in a prospective, randomized, double-blinded study. Twenty patients received TA given in two bolus doses of 10 mg/kg each, the first just before surgical incision and the second 3 h later. In addition, a continuous infusion of TA, 1.0 mg. kg(-1). h(-1) for 10 h, was given after the first bolus dose. The remaining 20 patients formed a control group. Both groups used preoperative autologous blood donation and intraoperative autotransfusion. Intraoperative bleeding was significantly less (P: = 0.001) in the TA group compared with the control group (630 +/- 220 mL vs 850 +/- 260 mL). Postoperative drainage bleeding was correspondingly less (P: = 0.001) (520 +/- 280 vs 920 +/- 410 mL). Up to 10 h postoperatively, plasma D-dimer concentration was halved in the TA group compared with the control group. One patient in each group had an ultrasound-verified late deep vein thrombosis. In conclusion, we found TA, administrated before surgical incision, to be efficient in reducing bleeding during THR. Implications: In a prospective, double-blinded study of 40 patients undergoing total hip replacement, the preoperative administration of tranexamic acid reduced bleeding by 35%, probably by decreasing induced fibrinolysis. Whether tranexamic acid therapy can replace predonation of autologous blood or intraoperative autotransfusion requires further study 3. Anesth.Analg.2000;92:29-34. Tranexamic acid reduces red cell transfusion better than epsilon-aminocaproic acid or placebo in liver transplantation Dalmau,A.; Sabate,A.; Acosta,F.; Garcia-Huete,L.; Koo,M.; Sansano,T.; Rafecas,A.; Figueras,J.; Jaurrieta,E.; Parrilla,P. --- We evaluated the efficacy of the prophylactic administration of epsilon-aminocaproic acid and tranexamic acid for reducing blood product requirements in orthotopic liver transplantation (OLT) in a prospective, double-blinded study performed in 132 consecutive patients. Patients were randomized to three groups and given one of three drugs prophylactically: tranexamic acid, 10 mg. kg(-1). h(-1); epsilon-aminocaproic acid, 16 mg. kg(-1). h(-1), and placebo (isotonic saline). Perioperative management was standardized. Coagulation tests, thromboelastogram, and blood requirements were recorded during OLT and in the first 24 h. There were no differences in diagnosis, Child score, or preoperative coagulation tests among groups. Administration of packed red blood cells was significantly reduced (P = 0.023) during OLT in the tranexamic acid group, but not in the epsilon-aminocaproic acid group. There were no differences in transfusion requirements after OLT. Thromboembolic events, reoperations, and mortality were similar in the three groups. Prophylactic administration of tranexamic acid, but not epsilon-aminocaproic acid, significantly reduces total packed red blood cell usage during OLT. IMPLICATIONS: In a randomized study of 132 consecutive patients undergoing liver transplantation, we found that tranexamic acid, but not epsilon-aminocaproic acid, reduced intraoperative total packed red blood cell transfusion 4. Anesthesiology 2000;92:674-82. Comparison of blood-conservation strategies in cardiac surgery patients at high risk for bleeding Nuttall,G.A.; Oliver,W.C.; Ereth,M.H.; Santrach,P.J.; Bryant,S.C.; Orszulak,T.A.; Schaff,H.V. --- BACKGROUND: Aprotinin and tranexamic acid are routinely used to reduce bleeding in cardiac surgery. There is a large difference in agent price and perhaps in efficacy. METHODS: In a prospective, randomized, partially blinded study, 168 cardiac surgery patients at high risk for bleeding received either a full-dose aprotinin infusion, tranexamic acid (10-mg/kg load, 1-mg x kg(-1) x h(-1) infusion), tranexamic acid with pre-cardiopulmonary bypass autologous whole-blood collection (12.5% blood volume) and reinfusion after cardiopulmonary bypass (combined therapy), or saline infusion (placebo group). RESULTS: There were complete data in 160 patients. The aprotinin (n = 40) and combined therapy (n = 32) groups (data are median [range]) had similar reductions in blood loss in the first 4 h in the intensive care unit (225 [40-761] and 163 [25-760] ml, respectively; P = 0.014), erythrocyte transfusion requirements in the first 24 h in the intensive care unit (0 [0-3] and 0 [0-3] U, respectively; P = 0.004), and durations of time from end of cardiopulmonary bypass to discharge from the operating room (92 [57-215] and 94 [37, 186] min, respectively; P = 0.01) compared with the placebo group (n = 43). Ten patients in the combined therapy group (30.3%) required transfusion of the autologous blood during cardiopulmonary bypass for anemia. CONCLUSIONS: The combination therapy of tranexamic acid and intraoperative autologous blood collection provided similar reduction in blood loss and transfusion requirements as aprotinin. Cost analyses revealed that combined therapy and tranexamic acid therapy were the least costly therapies 5. J.Thorac.Cardiovasc.Surg. 2000;119:575-80. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study De Bonis,M.; Cavaliere,F.; Alessandrini,F.; Lapenna,E.; Santarelli,F.; Moscato,U.; Schiavello,R.; Possati,G.F. --- OBJECTIVES: We sought to investigate the effect of topical application of tranexamic acid into the pericardial cavity in reducing postoperative blood loss in coronary artery surgery. METHODS: A prospective, randomized, double-blind investigation with parallel groups was performed. Forty consecutive patients undergoing primary coronary surgery were randomly assigned to group 1 (tranexamic acid group) or group 2 (placebo group). Tranexamic acid (1 g in 100 mL of saline solution) or placebo was poured into the pericardial cavity and over the mediastinal tissues before sternal closure. The drainage of mediastinal blood was measured hourly. RESULTS: Chest tube drainage in the first 24 hours was 485 +/- 166 mL in the tranexamic acid group and 641 +/- 184 mL in the placebo group (P =.01). Total postoperative blood loss was 573 +/- 164 mL and 739 +/- 228 mL, respectively (P =.01). The use of banked donor blood products was not significantly different between the two groups. Tranexamic acid could not be detected in any of the blood samples blindly collected from 24 patients to verify whether any systemic absorption of the drug occurred. There were no deaths in either group. None of the patients required reoperation for bleeding. CONCLUSIONS: Topical application of tranexamic acid into the pericardial cavity after cardiopulmonary bypass in patients undergoing primary coronary bypass operations significantly reduces postoperative bleeding. Further studies must be carried out to clarify whether a more pronounced effect on both bleeding and blood products requirement might be seen in procedures with a higher risk of bleeding 6. J.Thorac.Cardiovasc.Surg. 2002; 123(6):1084-91 Hemostatic effects of tranexamic acid in elective thoracic aortic surgery: a prospective, randomized, double-blind, placebo-controlled study Casati,V.; Sandrelli,L.; Speziali,G.; Calori,G.; Grasso,M.A.; Spagnolo,S. --- OBJECTIVE: We studied the hemostatic effects of tranexamic acid in patients undergoing elective surgery involving the thoracic aorta. METHODS: In a double-blind, randomized fashion, 60 consecutive patients were assigned to two treatment groups: 30 patients (placebo group) received infusion of saline solution, and 30 (treatment group) received tranexamic acid (1 g before skin incision, an infusion of 400 mg/h during the operation, and 500 mg in the pump priming). Perioperative bleeding was considered as a primary outcome. Perioperative allogeneic transfusions, major thrombotic complications (myocardial infarction, pulmonary embolism, renal insufficiency), and surgical outcomes were also considered. RESULTS: Patients treated with tranexamic acid showed significant reductions in postoperative bleeding, both in terms of the amount collected during the first 4 postoperative hours (median 307 mL, interquartile range 253-361 mL in the placebo group vs median 211 mL, interquartile range 108-252 mL in the treatment group, P =.002) and in terms of total bleeding (median 722 mL, interquartile range 574-952 mL in the placebo group vs median 411 mL, interquartile range 313-804 mL in the treatment group, P =.04). Consequently, the number of patients transfused differed significantly between groups (21 patients [72.4%] in the placebo group vs 13 [44.8%] in the treatment group, P =.033). Patients in the treatment group showed significant reductions in the total amount for the entire group of packed red cells transfused (13,500 mL in the treatment group vs 28,000 mL in the placebo group, P =.012) and in the total amount of allogeneic transfusions (23,400 mL in the treatment group vs 53,000 mL in the placebo group, P =.024). No differences in perioperative thrombotic complications were found. CONCLUSIONS: In this initial series of patients undergoing thoracic aortic surgery, tranexamic acid appeared effective in reducing perioperative bleeding, with a significant reduction in the need for allogeneic transfusions and without any increased risk of thrombotic complications 7. Ann.Thorac.Surg. 2001; 71:1508-1511 Is tranexamic acid safe in patients undergoing coronary endarterectomy? Ruel,M.A.; Wang,F.; Bourke,M.E.; Dupuis,J.Y.; Robblee,J.A.; Keon,W.J.; Rubens,F.D. --- BACKGROUND: Patients undergoing coronary endarterectomy during coronary artery bypass grafting (CABG) are at increased risk of perioperative myocardial infarction due to coronary intimal disruption. Data assessing the safety of the antifibrinolytic drug tranexamic acid (TA) in patients undergoing this procedure are lacking. METHODS: From September 1997 to December 1999, 221 patients underwent nonemergency primary CABG with endarterectomy of the right coronary artery alone in 149, the left anterior descending in 35, or both right and left anterior descending in 27. TA was administered intraoperatively to 87 patients (TA group: average total dose 62 +/- 4.4 mg/kg; range 20 to 109 mg/kg), and was not administered to 134 patients (No TA group). RESULTS: The patient characteristics of the 2 groups were similar. In-hospital mortality consisted of 2 patients in the TA group and 4 patients in the No TA group. Perioperative myocardial infarction rates were 2% and 5% in the TA and No TA groups, respectively (p = 0.49). The relative risk for any type of perioperative cardiac ischemic event in the TA group versus the No TA group was 0.77 (95% CI; 0.4, 1.2). Patients in the TA group had a significant reduction in postoperative chest tube drainage (685 versus 894 mL in the TA versus No TA groups, respectively) and in the use of fresh-frozen plasma (p = 0.03). CONCLUSIONS: These results suggest that the clinical effectiveness of tranexamic acid in reducing postoperative blood loss in patients undergoing coronary endarterectomy is not associated with a higher incidence of myocardial ischemia-related complications 8. Arch-Orthop-Trauma-Surg. 2000; 120(9): 518-20 Reduction of blood loss using tranexamic acid in total knee and hip arthroplasties. Ido,-K; Neo,-M; Asada,-Y; Kondo,-K; Morita,-T; Sakamoto,-T; Hayashi,-R; Kuriyama,-S --- There have been several attempts to reduce postoperative blood loss in patients undergoing total arthroplasty. Benoni et al. reported the usefulness of tranexamic acid in total knee arthroplasty (TKA). We investigated its effect in TKA and total hip arthroplasty (THA). Blood loss was significantly reduced in patients given tranexamic acid in both the TKA and THA groups, and no severe complications, such as venous or pulmonary thrombosis, were noted in any of the patients who received the agent. Administration of tranexamic acid seems to be useful for reducing postoperative blood loss in TKA and THA. 9. Anesthesiology. 2001 Jan; 94(1): 8-14 Tranexamic acid administration after cardiac surgery: a prospective, randomized, double-blind, placebo-controlled study. Casati,-V; Bellotti,-F; Gerli,-C; Franco,-A; Oppizzi,-M; Cossolini,-M; Calori,-G; Benussi,-S; Alfieri,-O; Torri,-G --- BACKGROUND: Many different doses and administration schemes have been proposed for the use of the antifibrinolytic drug tranexamic acid during cardiac surgery. This study evaluated the effects of the treatment using tranexamic acid during the intraoperative period only and compared the results with the effects of the treatment continued into the postoperative period. METHODS: Patients undergoing elective cardiac surgery with use of cardiopulmonary bypass (N = 510) were treated intraoperatively with tranexamic acid and then were randomized in a double-blind fashion to one of three postoperative treatment groups: group A: 169 patients, infusion of saline for 12 h; group B: 171 patients, infusion of tranexamic acid, 1 mg x kg(-1) x h(-1) for 12 h; group C: 170 patients, infusion of tranexamic acid, 2 mg x kg(-1) x h(-1) for 12 h. Bleeding was considered to be a primary outcome variable. Hematologic data, allogeneic transfusions, thrombotic complications, intubation time, and intensive care unit and hospital stay duration also were evaluated. RESULTS: No differences were found among groups regarding postoperative bleeding and outcomes; however, the group treated with 1 mg x kg(-1) x h(-1) tranexamic acid required more units of packed red blood cells because of a significantly lower basal value of hematocrit, as shown by multivariate analysis. CONCLUSIONS: Prolongation of treatment with tranexamic acid after cardiac surgery is not advantageous with respect to intraoperative administration alone in reducing bleeding and number of allogeneic transfusions. Although the prevalence of postoperative complications was similar among groups, there is an increased risk of procoagulant response because of antifibrinolytic treatment. Therefore, the use of tranexamic acid during the postoperative period should be limited to patients with excessive bleeding as a result of primary fibrinolysis. 10. Int-J-Cardiol. 2002 Jun; 83(3): 267-8 Acute myocardial infarction after oral tranexamic acid treatment initiation. Mekontso-Dessap,-A; Collet,-J-P; Lebrun-Vignes,-B; Soubrie,-C; Thomas,-D; Montalescot,-G --11. Eur-J-Haematol. 2002 May; 68(5): 307-9 Pulmonary embolism associated with tranexamic acid in severe acquired haemophilia. Taparia,-M; Cordingley,-F-T; Leahy,-M-F --- Tranexamic acid (an antifibrinolytic agent) is of proven benefit in the treatment of bleeding in patients with congenital and acquired coagulation disorders. We report the case of a patient with an acquired Factor VIII inhibitor, who was on a prophylactic dose of tranexamic acid because of recurrent bleeding episodes and developed a pulmonary embolism. Although studies using tranexamic acid have not shown a definite increased risk for the development of venous thrombosis, this is the likely cause of the pulmonary embolism in this patient. 12. Gut. 2001 Sep; 49(3): 372-9 Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points. Hawkey,-G-M; Cole,-A-T; McIntyre,-A-S; Long,-R-G; Hawkey,-C-J --- INTRODUCTION: Pharmacotherapy for upper gastrointestinal bleeding has been difficult to evaluate because clinical end points are infrequent and affected by other factors. AIMS: To evaluate whether blood in the stomach at endoscopy reflected severity of bleeding, predicted clinical outcomes, and could be altered by therapeutic agents. METHODS: We studied 414 consecutive admissions with suspected upper gastrointestinal bleeding. Patients were randomised to receive lansoprazole 60 mg followed by 30 mg four times daily, tranexamic acid 2 g followed by 1 g four times daily, both drugs, or placebo for four days, until discharge or a clinical end point occurred. Logistic regression analysis was used to determine predictors of endoscopic changes and clinical outcomes, and to investigate the effects of drug treatments on blood in the stomach. RESULTS: Of 414 patients with suspected upper gastrointestinal bleeding, 379 were endoscoped. Upper gastrointestinal bleeding was confirmed in 316. Sixteen required surgery within 30 days and 16 died on the index admission. Trial treatments were evaluable on a per protocol basis in 228 patients. The amount of blood in the stomach was found to reflect initial risk, with significant associations with high risk categorisation (odds ratio 3.7 (95% confidence interval 1.5-9.4) for more than a trace v none/trace), age (1.5 (1.1-1.9) per decade), and initial pulse (1.02 (1.00-1.04) per beat), and to predict rebleeding (9.2 (4.6-18.7)) and surgery (8.2 (2.9-22.9)). Other stigmata were less significant in these respects. The amount of blood in the stomach at endoscopy was reduced significantly by both lansoprazole (0.22 (0.07-0.63)) and tranexamic acid (0.27 (0.09-0.81)), although there was no evidence of synergy. CONCLUSIONS: Blood in the stomach reflects clinical features in patients with acute upper gastrointestinal bleeding and is reduced by treatment with lansoprazole and tranexamic acid. 13. Transfusion. 1991 May; 31(4): 345-8 Lack of efficacy of tranexamic acid in thrombocytopenic bleeding. Fricke,-W; Alling,-D; Kimball,-J; Griffith,-P; Klein,-H --- A controlled, randomized, double-blind study was performed to assess the effect of the oral antifibrinolytic agent tranexamic acid in patients with amegakaryocytic thrombocytopenia as regards their need for platelet transfusions and the number of bleeding episodes experienced. Each patient served as his or her own control and received sequential, randomized courses of either tranexamic acid or an identical placebo. The need for platelet transfusions due to bleeding and the total number of bleeding episodes were compared for tranexamic acid and placebo courses. Patients received platelet transfusions at the discretion of their personal physician and kept detailed records of bleeding episodes. Of three patients who completed the full study, none had a reduction in the need for platelet transfusions. Moreover, in the eight patients who participated in the study, there was no reduction in number of bleeding episodes during tranexamic acid treatment as compared to the number with placebo. Our data indicate that the prophylactic administration of tranexamic acid does not decrease dependence on platelet transfusions or decrease bleeding episodes in patients with bleeding due to amegakaryocytic thrombocytopenia. Transamine Therapeutic use i.v. p.o. 2 1 3 1.5g ( 3 4 ) Indicaitons: 1. Prevention of bleeding after surgery or trauma a. tooth extraction in patients with hemophilia trasamine 1 g tid x 5 days + factor VIII and IX (Forbes CD et al. BMJ 1972; ii:311-3) Hemophilia after extraction Transamine 25mg/Kg B.W. p.o. qid x 5 days + Factor VIII or IX (Sindet-Pedasen S et al. J oral Maxillofas Surg 1986; 44:703-7) b. Cervical conization 14% rebleeding rate in open technique 1.5 g/day x 12 day, effective in double-blind studies (Rybo G et al. Acta Obstet Gynalcol Sandi 1976; 51:347-50) c. Bleeding in Tonsillectory and adenoidectomy Double-blind trial Transamine 10mg/Kg BW iv. significantly reduced rebleeding rate (Verstraete M, et al. Acta Clin Belg 1977; 32:136-41) d. Prostatic surgery Reduced 50% of rebleeding after prostatectomy in control group to 24% in treatment group (Hedlung PO, Scand J Urol Nephrol 1969; 3:177-82, Kaufmann J et al. Urologie 1969; 8:57-59) e. Bleeding in ocular trauma Precent rebleeding in the anterior chamber and vitreous body by historical control studies (Jerndal T, et al. Acta Ophthalmol 1976; 54:417-29. Varnek L, et al. Acta ophthalmol 1980; 55:787-93) f. Oral surgery in patients taking anticoagulatants Operative area rinsed with 10ml 4.8% transamine and continue for 7 days 2 min rinse 10 ml transamine qid. (sindet-Paterson S et al. New Engl J Med 1989; 320:840-3) 2. Prevention of rebleeding in subarachmoid hemorhage or ruptured aneurysms Favor: Roos Y et al Neurology 2000; 54:77-82. Chandra B. Ann Neurol 1978; 3:502-4. Fodstad H et al. Surg Neurol 1978; 10:9-15. Maurice-Williams RC. BMJ 1978; 1:945-7 Vermeulen M et al. New Engl J Med 1984; 311:432-7. Against: Fodstad H et al. Neuro Surg 1981; 8:158-65. Gelmers JH. Acta Neuro Chirug 1980; 52:45-50. Kaste M. Stroke 1969; 10:519-22. Van Rossum J et al. Ann Neurol 1977; 2:238-42. Case report in a hemodialysis patient. Nephrol Dialy Transpl 2000; 15:107-9. 3. Treatment of primary or IUD-induced menorrhagia Total 1 1.5 g p.o reduce menorrhagia (randomized trials. Callender ST et al. BMJ 1970; iv:214-6. Venmylea J et al. Thromobosis et Haemorrhagica.1968; 20:583-7. Review: Preutice A. BMJ 1999; 319:1343-5. ) 4. Treatment of gastric and intestinal bleeding double-blind studies in diffuse gastrititis or peptic ulcer Barer D et al. New Engl J Med 1983; 308:1571-5. Comack F et al. Lancet 1973; 1:1207-8. Henry DA et al. BMJ 1989; 298:1142-6 Hawkey GM et al. (for rebleeding) Gut 2001; 49:372-9. 5. Prevention of sportaneous or postoperative corneal edema. Double blind study for corneal edema after trabeculectomy or cataract operation: effective Bramsen T et al. Acta Ophthamol 1978; 56:121-6. Bramsen T. Acta Ophthelmol 1978; 56:998-1005. 6. Treatment of hereditary angioneurotic edema Antosomal dominant disease due to C-1-esterase difficiency Double-blind study reduction of edema, long life used Blomhe G. Acta Med Scand 1972; 192:293-8. Scheiffer AL et al. New Engl J Med 1972; 287:452-4. 7. Treatment of non-heriditary angioedema Caused by allergy or autoimmune disease Double-blind study long-term use effective Munch EP et al. Allergy 1985; 40:92-7. 8. Prevention of bleeding in acute promyelocytic leukemia Open study Schwartz BS et al. Ann Int Med 1986; 105:873-7. Double-blind study Arrisati G et al. Lancet 1989; 11:122-4. effective 9. Prevention of bleeding after cardio-pulmonary bypass or coronary and arterectomy Randomized trial Ruel MA et al. Ann Thorac Surg 2001; 71:1508-11. Karsi JM et al. J Thorac Cardiovasc Surg 1995; 110:835-48. DeBonis M et al. J Thorac Candivas Surg 2000; 119:575-80. Wong BI. Ann Thorac Surg 200; 69:808-16. Castati V et al. prolonged use is not effective. Anesthesial 2001; 94:8-14. 10. Reduce bleeding in thoracic aortic surgery Randomized study effective without increase thrombosis incidence Casati V et al. J Throac Cardiovasc Surg 2002; 123:134-9. 11. Reduce red cell transfusion in liver transplantation effective, not increase arterial thrombosis Dalmau A. et al. Anesth Analg 2000; 91:129-34. Dalmau A. et al. Anesth Analg 2001; 93:514. Karkouti K. Anesth Analg 2000; 91:244. Adverse reactions Taparia M et al. Pulmonary embolism (iv. Transamine) Europ J Hematol 2002; 68:307. Mekontso-Dessap A. et al. Acute MI, (p.o. transamine) Int J Cardiol 2002; 83:267-8. Markivardt F. et al. Thrombosis Res 1976; 9:143-52. This document was created with Win2PDF available at http://www.daneprairie.com. The unregistered version of Win2PDF is for evaluation or non-commercial use only.