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Ann Thorac Surg 1996;61:1131-1135
© 1996 The Society of Thoracic Surgeons

Original Article: Cardiovascular

Tranexamic Acid Reduces Postbypass Blood Use: A Double-Blinded, Prospective, Randomized Study of 210 Patients

Demetrios Katsaros, MD, Mark Petricevic, PhD, Norman J. Snow, MD, Dennis D. Woodhall, MD, Robert Van Bergen, MD

Division of Cardiothoracic Surgery, Fairview Hospital, Cleveland, Ohio


   Abstract
Top
 Footnotes
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background. Pharmacologic intervention to minimize postbypass bleeding and blood product transfusions has received increasing attention for both medical and economic reasons.

Methods. Two hundred ten patients were entered into a double-blinded, prospective, randomized study to receive either 10 g of the fibrinolytic inhibitor tranexamic acid before incision (n = 104) or 250 mL of placebo saline solution (n = 106). All subjects requiring cardiopulmonary bypass were deemed suitable, including those having first-time coronary bypass grafting, valve replacement, and reoperation.

Results. There were no statistically significant differences between the groups with respect to demographic or operative characteristics. The tranexamic acid group had a 48% reduction in 24-hour blood drainage (p < 0.001) and received 69% fewer total units of packed red blood cells, 83% fewer total units of plasma, and 75% fewer platelet transfusion units than controls. Only 13 of 104 tranexamic acid patients received blood products versus 33 of 106 controls (p < 0.001). The incidences of thrombotic complications, perioperative myocardial infarction, renal failure, and neurologic complications were not significantly different between the two groups. The tranexamic acid group had 0% mortality versus 1.9% for controls (not significant).

Conclusions. Tranexamic acid is safe and effective in reducing blood loss and blood use in a wide variety of cardiac surgical patients.


   Introduction
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 Abstract
 Introduction
Material and Methods
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 References
 
See also page 1135.

Bleeding after cardiopulmonary bypass (CPB) continues to be a problem. Between 30% and 70% of open heart patients will require blood product transfusions [1]. Although small, the risk of transmitting hepatitis, human immunodeficiency virus, cytomegalovirus, or other infectious agents remains a concern.

Significant postbypass hemorrhage is reported in 6% to 25% of open heart patients postoperatively [2, 3]. Fibrinolysis can be detected in 50% of postbypass patients and has been reported to be the cause of 25% to 45% of significant postbypass bleeding [3]. Bleeding requiring reexploration occurs in 2% to 7% of postbypass patients, and 50% to 80% of these patients will not have an identifiable surgical bleeding source [2]. Autotransfusion reduces but does not eliminate the need for transfusion. The risk and cost of postbypass bleeding justifies the search for new ways of diminishing blood loss after CPB. Various pharmacologic agents have been used to diminish postbypass bleeding. These include prostacyclin [4], desmopressin [5, 6], aprotinin [1, 7], {epsilon}-aminocaproic acid [8], and most recently tranexamic acid (TXA) [6, 9–11].

Antifibrinolytics such as TXA appear to act by attaching to the lysine binding sites of plasminogen and plas-min [12]. Saturation of the lysine binding sites displaces plasminogen from its fibrin surface, thus inhibiting fibrinolysis. As an antifibrinolytic, TXA has the same low toxicity as {epsilon}-aminocaproic acid, but is 6 to 10 times more potent on a molar basis and has a longer half-life and a higher and more sustained antifibrinolytic activity in tissue [12].

There are contradictory reports regarding the effectiveness of TXA [6, 13, 14]. Studies that have shown no reduction in blood loss with TXA have been criticized for using an ineffective dose or for improper administration of the drug [7, 13, 14].

We report the results of a prospective, double-blinded, randomized study of 210 patients in which TXA was administered to test the hypothesis that prophylactic TXA would diminish postbypass bleeding and, therefore, blood product use.


   Material and Methods
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 Abstract
 Introduction
 Material and Methods
Results
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 Acknowledgments
 References
 
After institutional approval was obtained on September 9, 1992, all patients scheduled for open heart operations between February 1993 and September 1993 were eligible for enrollment. Contraindications for enrollment included previous pulmonary embolism, Takayasu's arteritis, and known allergy to TXA.

After we obtained written informed consent, 211 patients were independently randomized to receive coded infusions of either TXA or placebo. Only two cardiac surgeons (R.V.B. and D.D.W.) participated in the study. Preoperative laboratory studies included complete blood count, SMA-18, prothrombin time, partial thromboplastin time, urinalysis, chest roentgenography, and electrocardiography.

After the induction of anesthesia, the control group of 106 patients received 250 mL of normal saline solution, and the TXA group of 104 patients received 10 g of TXA diluted to 250 mL with normal saline solution intravenously over 20 minutes. No incision was made until the completion of the infusions.

One patient (patient 109) was eliminated from the study because of improper data collection. Before CPB was established, each patient received 300 IU/kg of bovine lung heparin. Additional heparin was administered for activated clotting times less than 400 seconds. The activated clotting time was monitored every 30 minutes. Heparin was reversed with protamine sulfate using dose-response curves.

Shed mediastinal blood was measured for the first 24 hours postoperatively. Information was stored in a bedside computer. Packed red blood cells were transfused for a hemoglobin threshold of 7 mg/dL or less. Transfusion of fresh frozen plasma was based on abnormal prothrombin time and the rate of bleeding. Platelet transfusion threshold was a platelet count of 100,000 x 103/µL or less associated with one or more of the following: increased rate of blood loss, prior use of aspirin, and heparin drip preoperatively.

Data were expressed as mean ± standard error of the mean unless otherwise noted. Comparison of parametric patient data was done using an unpaired Student's t test or the Mann-Whitney U test, where appropriate. Comparison of nonparametric patient data was done using {chi}2. A p value of less than 0.05 was considered significant.


   Results
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 Abstract
 Introduction
 Material and Methods
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Comment
 Acknowledgments
 References
 
As seen in Table 1Go, the demographic characteristics of the two groups were similar. Preoperative and postoperative hemoglobin concentrations, platelet count, prothrombin time, and partial thromboplastin time were not significantly different between the two groups (Tables 2, 3GoGo). The hemoglobin concentration at discharge was significantly greater in the TXA group (10.02 mg/dL) than in the control group (9.18 mg/dL; p < 0.003).


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  		Table 1. . Patient Demographics
 

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  		Table 2. . Preoperative Hematologic Profilea
 

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  		Table 3. . Postoperative Hematologic Profilea
 
Intraoperative demographics (Table 4Go) were similar between the two groups with respect to CPB time (85 versus 84 minutes), cross-clamp time (45 versus 46 minutes), proportion of patients in whom the internal mammary artery conduit was used (56% versus 58%), number of bypass grafts per patient (3.1 versus 2.7), proportion of redo operations (6.7% versus 4.7%), and proportion of combined carotid endarterectomies with coronary bypass procedures (4.8% versus 3.8%). There were no significant differences between the groups. The difference between numbers of valvular operations did not achieve statistical significance, which may reflect the small sample size in these groups.


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  		Table 4. . Operative Characteristics
 
Table 5Go compares blood loss between the two groups in the first 24 hours after operation. Also compared is the volume of autotransfusion. Total blood loss for 24 hours was 474 7 ± 24 mL in the TXA group versus 906 ± 51 mL in the control group. This represents a 48% decrease in blood loss and is statistically significant (p < 0.0001). The greatest amount of blood loss occurred in the first 8 hours and decreased with each subsequent 8-hour shift in both groups. As compared with the control group the TXA group had a 53% decrease from 0 to 8 hours, 43% decrease from 9 to 16 hours, and a 31% decrease from 17 to 24 hours. Autotransfusion for the two groups was 89 ± 18 mL in the TXA group versus 273 ± 34 mL in the controls (p < 0.0001).


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  		Table 5. . Postoperative Blood Loss in Milliliters
 
Transfusion requirements for the two groups are compared in Table 6Go. Eleven patients in the TXA group received packed red blood cells as compared with 27 patients in the control group. Platelets were given to 3 patients in the TXA group as opposed to 9 patients in the control group. Fresh frozen plasma was transfused to 3 patients in the TXA group as compared with 11 patients in the control group. Although 31% of controls were exposed to blood products, only 12.5% of the TXA group received blood products (p < 0.001).


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  		Table 6. . Patients Receiving Blood Products
 
There were two deaths in the control group and none in the study group. The first patient the control group who died (patient 26) had an uneventful aortic valve replacement for aortic stenosis. On the 4th postoperative day, cardiogenic shock developed and he died 14 hours later of multiple organ failure. The second patient in the control group who died (patient 167) was brought to the operating room in cardiogenic shock on inotropic support and an intraaortic balloon pump. In the immediate postoperative period, he became profoundly hypotensive and unresponsive to external cardiac massage. He was opened and during internal cardiac massage by the resident staff sustained an irreparable injury to the right ventricle and exsanguinated. Postoperative myocardial infarction was not seen in either group. One patient in the TXA group required reexploration versus 5 in the control group. A surgical site of bleeding was identified in the TXA patient at a proximal saphenous vein graft anastomosis. Of 5 patients reexplored in the control group, 4 had identifiable surgical sites of bleeding, and 1 patient had no identifiable site.

Three patients in the TXA group and 2 in the control group experienced cerebrovascular events. In the TXA group, patient 130 had an intraoperative air embolism during cannulation of the superior pulmonary vein. Patient 150 experienced a retinal artery embolus on the fourth postoperative day and was subsequently operated on after a second episode, 3 weeks later, for an ulcerated plaque in the corresponding carotid artery. In patient 97 recurrent episodes of left-sided weakness developed associated with periods of hypotension. This resolved without a residual deficit.

Two patients in the control group experienced central nervous system complications. After a combined carotid endarterectomy and coronary artery bypass grafting, a right hemiparesis and mild expressive aphasia corresponding to the operated carotid artery developed in patient 41. Patient 44 experienced transient bilateral blindness but had no permanent sequelae.

Renal failure occurred in 1 patient in the TXA group and none in the control group. One episode of deep vein thrombosis and pulmonary embolism occurred in the control group and none in the study group. Supraventricular arrhythmias were seen with equal frequency in both groups. One patient in the TXA group had development of refractory ventricular arrhythmia requiring implantable cardioverter-defibrillator placement.


   Comment
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Acknowledgments
 References
 
There are more than 250,000 open heart procedures performed in the United States every year. Anywhere from 30% to 70% of these patients will require blood products. Thus between 75,000 and 175,000 Americans will be exposed to blood products as a direct result of open heart operations. The risk of transmitting hepatitis, cytomegalovirus, human immunodeficiency virus, mononucleosis, and other infectious agents with blood products, although small, remains a concern. Often overlooked is the risk of fulminant noncardiogenic pulmonary edema [16]. Moreover, blood transfusions are immunosuppressive and as such are associated with carcinogenesis and higher postoperative infection rates [17, 18]. With these concerns in mind, the search for new methods for diminishing postbypass blood loss is justified.

Significant postbypass hemorrhage is reported in 6% to 25% of open heart patients postoperatively [2, 3]. About 70% of severe hemorrhages may be controlled medically. Kevy and associates [3] detected fibrinolysis in 50% of postbypass patients and showed it to be the cause of 25% to 45% of significant postbypass bleeding. In this study, blood loss in excess of 600 mL in the first 8 hours occurred in 31% of the controls but in only 3.8% of the study group (p < 0.001). The 33 control patients who experienced a blood loss of more than 600 mL in the first 8 hours accounted for nearly all the blood product use in that group. As compared with the control group, the TXA group received a total of 69% fewer units of packed red cells (55 versus 17 units), 83% fewer units of fresh frozen plasma (29 versus 5 units), and 75% fewer units of platelets (8 versus 2 platelet transfusion packs). Because the majority of TXA patients were undergoing first-time sternotomies (97/104), larger transfusion savings may be anticipated for longer or more complex operations.

Bleeding requiring reexploration occurs in 2% to 7% of postbypass patients, and 50% to 80% of this hemorrhage will not have a discrete bleeding source [2]. In this study 4.7% of the controls but only 0.96% of the TXA group required reexploration for excessive bleeding. However, this difference was too small for statistical comparison.

Although the antifibrinolytic effects of TXA are well known, its most important effect may well be its inhibition of plasmin-induced platelet activation by its blockade of the plasminogen thrombin receptor [19]. Platelets pretreated with TXA have adenosine diphosphate concentrations that are 3 to 4 times higher than those not treated or those that had been given TXA after CPB [19]. Tranexamic acid may preserve platelet function by reducing the effect of plasmin on glycoprotein Ib platelet receptors [12]. Some animal studies have suggested the preservation of platelet concentrations, but this did not occur in this study [20].

Studies that have not shown reduction in postbypass bleeding with TXA used the drug after CPB, long after fibrinolysis and platelet degranulation have occurred [14, 15, 19]. To be most effective, antifibrinolytic agents should be used prophylactically. However, in the face of proven fibrinolysis, antifibrinolytic agents have been shown to be hemostatic even when used in the postbypass period [3].

Scattered reports have implicated the use of TXA in various thrombotic and allergic reactions. Of particular concern is the reported association of TXA with thrombosis of the extracranial and intracranial carotid arteries [21, 22]. Davies and Howell [21] reported a case of fatal thrombosis in a patient taking chronic large doses of TXA. At autopsy the area of thrombus was found in an occult area of Takayasu's arteritis in a 38-year-old woman. Rydin and Lundberg [22] reported intracranial thrombosis in 2 young female patients, but no autopsy data were given. Case reports of retinal artery occlusion, central venous stasis retinopathy, acute tubular necrosis, and idiopathic deep venous thrombosis have all been ascribed to repeated TXA use [23, 24].

In contrast to the case reports mentioned above, large series have failed to show any thrombotic complications with TXA. Bekassy and associates [25] reported no thrombotic complications in a retrospective review of 3,014 women taking TXA. Our study failed to show any increased incidence of postoperative myocardial infarction, cerebrovascular accident, pulmonary embolism, or thrombosis related morbidity or mortality in patients treated with TXA as a single preincision dose. This is in agreement with other controlled studies using TXA [6, 9–11]. Furthermore, histopathologic studies by Astedt and associates [26] have shown that TXA does not supress fibrinolytic activity in human vessel walls.

Aprotinin is the most recently available pharmacologic agent demonstrated to decrease postoperative blood loss [1]. It has been shown to be highly effective in reducing postoperative bleeding; however, it has been associated with significant complications, which may be related to inadequate heparinization while on CPB. The risk of anaphylaxis (<1 in 1,000) is ever-present, thereby limiting its use. One dose of TXA cost our institution $130.00 as opposed to $1,000.00 a dose for aprotinin. No changes in ACT monitoring are required with TXA.

Tranexamic acid appears to be a safe, cost-effective addition to the cardiac surgeon's arsenal to reduce post-CPB bleeding. With TXA and meticulous attention to hemostasis, decreased use of blood and blood products can be achieved.


   Acknowledgments
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
References
 
We thank Glenn Koyl, CCP, Thomas Farina, CCP, Victor Carcioppolo, CCP, Robin Higley, MS, RN, Jay L. Ankeney, MD, Carolyn Ciesla, and the Fraternal Order of Eagles through the Max Baer Heart Fund.


   Footnotes
Top
 Footnotes
Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Presented at the Forty-second Annual Meeting of the Southern Thoracic Surgical Association, San Antonio, TX, Nov 9–11, 1995.

Address reprint requests to Dr Van Bergen, Division of Cardiothoracic Surgery, Fairview Hospital, 18099 Lorain Ave, Suite 408, Cleveland, OH 44111.


   References
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Cosgrove DM III, Heric B, Lytle BW, et al. Aprotinin therapy for reoperative myocardial revascularization: a placebo-controlled study. Ann Thorac Surg 1992;54:1031–8.[Abstract]
  2. Verska JJ, Lonser ER, Brewer LA. Predisposing factors and management of hemorrhage following open-heart surgery. J Cardiovasc Surg 1972;13:361–8.[Medline]
  3. Kevy SV, Glickman RM, Bernhard WF, et al. The pathogenesis and control of the hemorrhagic defect in open heart surgery. Surg Gynecol Obstet 1966;123:313–8.[Medline]
  4. Fish KJ, Sarnquist FH, van Steennis C, et al. A prospective randomized study of the effects of prostacyclin on platelets and blood loss during coronary bypass operations. J Thorac Cardiovas Surg 1986;91:436–42.[Abstract]
  5. Salzman EW, Weinstein MJ, Weintraub RM, et al. Treatment with desmopressin acetate to reduce blood loss after cardiac surgery: a double-blind randomized trial. N Engl J Med 1986;314:1402–6.[Abstract]
  6. Horrow JC, Van Riper DF, Strong MD, Brodsky I, Parmet JL. Hemostatic effects of tranexamic acid and desmopressin during cardiac surgery. Circulation 1991;84:2063–70.[Abstract/Free Full Text]
  7. Lemmer JH, Stanford W, Bonney SL, et al. Aprotinin for coronary bypass operations: efficacy, safety, and influence on early saphenous vein graft patency. J Thorac Cardiovasc Surg 1994;107:543–53.[Abstract/Free Full Text]
  8. Daily PO, Lamphere JA, Dembitsky WP, et al. Effect of prophylactic epsilon-aminocaproic acid on blood loss and transfusion requirements in patients undergoing first-time coronary artery bypass grafting. A randomized, prospective, double-blinded study. J Thorac Cardiovasc Surg 1994;108:99–105.[Abstract/Free Full Text]
  9. Nakashima A, Matsuzaki K, Fukumura F, et al. Tranexamic acid reduces blood loss after cardiopulmonary bypass. ASAIO Trans 1993;39:185–9.
  10. Horrow JC, Hlavacek J, Strong MD, et al. Prophylactic tranexamic acid decreases bleeding after cardiac operations. Thorac Cardiovasc Surg 1990;99:70–4.
  11. Horrow JC, Van Riper DF, Strong MD, Grunewald KE, Parmet JL. The dose-response relationship of tranexamic acid. Anesthesiology 1995;82:383–92.[Medline]
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  14. Ovrum E, Holen EA, Abdelnoor M, et al. Tranexamic acid (cyclocapron) is not necessary to reduce blood loss after coronary bypass operations. J Thorac Cardiovasc Surg 1993;105:78–83.[Abstract]
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  20. Plotz FB, van Oeveren W, Aloe LS, et al. Prophylactic administration of tranexamic acid preserves platelet numbers during extracorporeal circulation in rabbits. ASAIO Trans 1991;37:M416–7.[Medline]
  21. Davies D, Howell DA. Tranexamic acid and arterial thrombosis [Letter]. Lancet 1977;1:49.[Medline]
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