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Tranexamic Acid, an Antifibrinolytic Drug with a Wide Range of Indications

There are two FDA-approved uses for tranexamic acid - to treat the symptoms of heavy menstrual bleeding (menorrhagia) and for short-term use in patients with hemophilia following tooth extraction. This article will also discuss the many other non-FDA approved, off-label uses of this drug.

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by Stuart M. Caplen, MD


Tranexamic acid (TXA) is a useful antifibrinolytic drug synthetic which is a chemical derivative of lysine. It works by blocking lysine binding sites on plasminogen molecules, inhibiting the conversion of plasminogen to plasmin. This prevents the breakdown of fibrin and stabilizes the fibrin meshwork produced in secondary hemostasis, reducing bleeding.


Tranexamic acid is available both in intravenous and oral formulations. Intravenous TXA has a reported half-life of two hours. Renal clearance is the major mechanism of excretion. TXA may reduce serum D-dimer levels but does not affect results of other coagulopathy tests. Heparin does not affect the activity of TXA, which may make it useful in heparinized patients.[1]


Uses of Tranexamic Acid

The only two FDA-approved uses for tranexamic acid are to treat the symptoms of heavy menstrual bleeding (menorrhagia) and in patients with hemophilia, for short-term use following tooth extraction. All other uses are considered off-label.


(All doses referenced are for adult patients except for post-tonsillectomy bleeding.)


Post-partum Hemorrhage

In the WOMAN trial, a randomized controlled trial (RCT) of over 20,000 subjects, the risk of death from bleeding in women with post-partum hemorrhage was significantly reduced with TXA when administered within 3 hours after delivery.[2]


A Cochrane Database review concluded that “TXA when administered intravenously reduces mortality due to bleeding in women with primary post-partum hemorrhage, irrespective of mode of birth, and without increasing the risk of thromboembolic events.”[3]


Typical post-partum hemorrhage TXA dose: 1 g of tranexamic acid intravenously as soon as possible after giving birth at a rate of 1ml/min followed by a second dose if bleeding continues after 30 minutes or restarts again within 24 hours after the first dose.[1]


Abnormal Uterine Bleeding

In one study of women with menorrhagia there was a significant decrease in menstrual blood loss with use of TXA versus no treatment or placebo.[4] In another study of subjects with heavy menstrual bleeding, TXA use resulted in a significant drop in blood loss.[5] A systematic review of the topic concluded that TXA was effective and safe for patients presenting with heavy menstrual bleeding and resulted in a decrease in menstrual blood loss of 34% to 54%. For intrauterine device-induced menorrhagia, short term TXA use reduced blood loss by up to 70% compared to placebo. [6]


Typical menorrhagia TXA dose: 1300 mg orally 3 times daily for up to 5 days during menses.[1]


Caesarian Delivery

A number of studies have found decreased blood loss with the use of TXA compared to placebo during caesarian section surgery.[7,8,9,10]


Typical caesarian delivery TXA dose: 1 g IV before surgery.[7,9]


Trauma

TXA has been tested extensively in trauma with acute blood loss. The CRASH-2 trial of over 20,000 trauma patients compared TXA with placebo and found a significant decrease in the mortality rate with TXA (4.9% died in the TXA group vs 5.7% in the placebo group). The results were time-dependent with TXA treatment between zero- and three-hours reducing mortality from traumatic injury, but treatment after three hours from injury actually increased mortality.[1,11]


The CRASH-3 study included over 12,000 trauma patients with traumatic brain injury (TBI) and no other source of extracranial bleeding, who were assigned to receive either placebo or TXA within three hours of injury. They found a substantial reduction in head injury-related deaths with TXA in patients with mild and moderate head injuries but no reduction in those with severe head injury. The risk of vascular occlusive event, stroke, and seizures was similar in both groups. The Glasgow coma scale (GCS) was used to define severity of injury, with mild to moderate TBI being a GCS of 9 to15 and severe TBI being a GCS of 3 to 8. Pupillary reactivity was also used to help assess severity.[11]


Another study of polytrauma patients with associated severe brain injury compared TXA to no treatment found no difference in mortality, which was a similar finding to the CRASH-3 study.[12]


Typical trauma TXA dose: 1 g intravenously as a loading dose within three hours of injury, with administration of an additional 1 g for continued bleeding.[1]


Vascular Complications

One of the concerns with use of TXA is it will increase the incidence of deep vein thrombosis or pulmonary embolism. In the very large CRASH -2 and CRASH-3 studies, no increase in these events from the use of TXA was found.[10,11]


Cardiac Surgery

TXA was trialed and used during cardiac surgery to try to reduce the amount of bleeding. In a number of studies patients treated with TXA were found to have a lower risk of bleeding than placebo, without a higher risk of death or thrombotic complications.[1] However, TXA was associated with a higher risk of postoperative seizures.[1,13] A meta-analysis concluded that seizures were found to be more likely with prolonged or open chamber cardiac procedures, and using lower doses of TXA could reduce bleeding episodes with less chance of seizures.[14] However, the optimal dose needed to reduce bleeding without increasing the risk of seizures, is still not established and requires further study.[15]


Typical TXA dose for cardiac surgery: Optimal dose is not established. A preoperative IV dose of 20 mg/kg or alternatively 10mg/kg followed by 1mg/kg/hour continuous IV infusion has been suggested to decrease both bleeding complications and the chance of seizures.[14,15]


Non-traumatic Brain Hemorrhage

A systematic review and meta-analysis of the use of TXA in non-traumatic brain hemorrhage found use of TXA reduced mortality 22% overall over placebo or standard treatment. The difference between the two groups was only significant for subarachnoid hemorrhage (SAH) and not intracerebral hemorrhage (ICH), suggesting it might be effective in SAH but not in ICH.[16]


In contrast, the ULTRA study (Ultra-early tranexamic acid after subarachnoid hemorrhage) found TXA treatment did not improve SAH clinical outcomes at six months and had no effect on mortality.[17]


A Cochrane database review found that antifibrinolytic treatment did not improve clinical outcomes in patients after SAH, although it did reduce the risk of rebleeding by 35%. The authors concluded that based on the current data, treatment with antifibrinolytic drugs cannot be recommended for use in subarachnoid hemorrhage from an aneurysmal origin.[19]


Another meta-analysis found that use of TXA significantly reduced the amount of hematoma expansion (HE) in ICH but had no effect on 90-day mortality.[18] A third meta-analysis had a similar result, that use of TXA reduced HE but had no effect on mortality, outcomes, need for neurosurgery, rebleeding, or the duration of the hospital stay.[20]


The FDA prescribing information for IV TXA specifically states that it is contraindicated in patients with subarachnoid hemorrhage due to anecdotal experience indicating that cerebral edema and cerebral infarction may be caused by the drug in such patients.[21]


Hip and Knee Surgery

A meta-analysis of the use of TXA in hip fracture surgery found blood loss and transfusion requirements were reduced by 46% without increasing thromboembolic events.[22,23] Another meta-analysis found a decrease in total blood loss with the use of TXA in hip fracture surgery. However, the authors felt that more robust data was needed from high-quality RCTs.[24]


A systematic review and meta-analysis on the use of TXA in knee and hip arthroplasties found oral, topical, intraarticular, or combinations of them all worked to reduce transfusion requirements but the combination of IV and topical was the most effective. In patients with a higher risk of thrombosis, topical TXA alone was suggested. Topical treatment refers to TXA that was applied topically to the exposed joint surface before closure of joint capsule. There was no increase in deep vein thrombosis (DVT) rates in the TXA treated groups compared to placebo or routine care.[25]


Typical TXA dose in orthopedic surgery: 10 mg/kg IV loading dose prior to skin incision, followed by a maintenance infusion of 1 mg/kg/hour.[1]


Spinal Surgery

There is some data that TXA can reduce blood loss in spinal surgery. A meta-analysis found it did reduce blood loss and the need for transfusion without increasing DVT risk, but larger RCTs were recommended to confirm the findings were needed. [10,26-28]


Typical TXA dose in spinal surgery: 10 mg/kg IV loading dose prior to skin incision, followed by a maintenance infusion of 1 mg/kg/hour.[1]


Prostate surgery

A metanalysis and systematic review found that TXA administration reduced bleeding from transurethral resection of the prostate (TURP) surgery but had no effect on the level of hemoglobin post-procedure or the need for blood transfusion.[28] Another meta-analysis found that TXA did reduce blood loss both for TURPs and prostatectomies over control groups and reduced the need for blood transfusion in the prostatectomy group.[30]


Typical dose of TXA in prostate surgery: Different dosing regimens used in various studies.


Dental Surgery

Anticoagulated patients

A meta-analysis and systemic review found that TXA, as compared to placebo, reduced the risk of bleeding when used before dental procedures in anticoagulated patients.[31] Some studies have found that use of oral mouthwashes with 5% TXA in anticoagulated patients for dental surgery reduced the amount of bleeding significantly.[1,32] Guidelines from the British Committee for Standards in Haematology are 5% tranexamic acid mouthwashes used four times a day for two days for anticoagulated patients undergoing dental surgery.[32]


Hemophilia Patients

In one study of hemophilia patients, oral TXA compared to placebo significantly reduced blood loss and transfusion requirements after tooth extraction.[33] Another study found that administering 1 gram of TXA orally starting 2 hours before dental extraction and then three times a day for 5 days resulted in a significant decrease in bleeding compared to placebo.[34] Other guidelines recommend 1 gram of oral TXA three times a day to be started the day before the procedure and continued for a total of 7 days.[35]


There are also suggested IV TXA guidelines for hemophilia patients (in addition to factor replacement therapy) before dental surgery. One manufacturer recommendation is TXA 10 mg/kg IV immediately prior to the surgery and then TXA 10 mg/kg IV 3 to 4 times daily for 2-8 days.[21]


If there is continued bleeding in the extraction site, one suggested therapy in hemophilia patients, is to have the patient use a 10% TXA solution for 1 minute as a mouthwash. In hemophilia patients getting tooth extractions it is recommended that a premade splint cover the empty tooth socket. The splint is removed during this treatment and replaced right after. This may be repeated every 2-3 hours if needed.[35]


Traumatic Hyphema

A Cochrane review found that TXA did not affect final vision outcome but did appear to reduce the risk of secondary bleeding in traumatic hyphema.[36]


Hemoptysis

A meta-analysis and systemic review found that use of TXA in hemoptysis reduced short-term mortality rate and led to shorter bleeding time, lower bleeding volume, shorter length of hospital stay, and less need for intervention compared with the control.[37]


Several small studies have tried endobronchial topical TXA for hemoptysis.[1] In one trial endobronchial TXA was found equivalent to epinephrine.[38] In another study, endobronchial TXA was found to be efficacious in about 40% of the patients with medical causes of hemoptysis and 100% of the patients with iatrogenic endobronchial bleeding after bronchoscopy, typically after a biopsy procedure.[39]


A study comparing nebulized inhaled TXA to saline for hemoptysis found a higher resolution of hemoptysis within 5 days of admission, lower hospital length of stay and fewer patients required invasive procedures with the inhaled TXA versus placebo.[40]

One systemic review and meta-analysis concluded that IV or nebulized TXA led to a shorter bleeding time, lower bleeding volume, shorter length of hospital stay, and less requirements for intervention compared with the control group. There was a significant decrease in the short-term mortality rate overall using all the trials (including observational studies), but this was not found to be a significant finding when only RCTs were used for the analysis.[41] A second systemic review and meta-analysis concluded that TXA for hemoptysis reduced bleeding volume, further need for interventions, and length of hospital stay, however, the findings were of low statistical power because of limited sample sizes.[42]


Dose of TXA in hemoptysis: In one study 500mg/5ml was nebulized three times a day in adults.[39]


Epistaxis

A trial comparing topical TXA to nasal packing, in anterior nasal epistaxis, found the TXA group had more subjects stop bleeding in ten minutes, a faster discharge time from the ED and higher patient satisfaction than with the use of nasal packing.[43] Another trial by the same group comparing topical TXA to nasal packing in patients on antiplatelet medication found faster bleeding cessation, less rebleeding at one-week, shorter emergency department length of stay, and higher patient satisfaction compared with nasal packing.[44]


However, another more recent larger trial of 496 epistaxis patients found no difference between topical TXA and placebo.[45]


Although early studies looked promising for topical TXA to treat epistaxis, a larger study found no difference between TXA use and placebo, which brings into question topical TXA’s efficacy for this condition.


Post-tonsillectomy Hemorrhage

A retrospective study of the use of three doses of nebulized TXA in pediatric patients for the treatment of post-tonsillectomy hemorrhage found TXA compared to routine care decreased the need for an operation to restore hemostasis by 44%.[46]


TXA dose: In the above study for patients between 2 and 18 years of age, 250 mg (0.25 mL) was used for those weighing less than 25 kg and 500 mg (0.5 mL) for those over 25 kg in three sequential nebulized doses delivered back-to-back. The actual dose administered was modified if needed so as not to exceed the maximum systemic dose based on age and weight of the patient. Intravenous TXA solution 1000mg/10 mL was used in the nebulizations in that study.[46]


Patients with Hematologic Malignancies

A limited number of studies have been performed with mixed results trialing TXA in patients with hematologic malignancies.[1]


A small trial of 12 patients with acute promyelocytic leukemia found decreased red cell and platelet transfusions were needed for the TXA group compared to the placebo group during chemotherapy.[47]


Another trial of three patients with amegakaryocytic thrombocytopenia receiving prophylactic TXA, each acting as their own control, found no difference in bleeding episodes or need for platelet transfusions by the use of TXA.[48]


In another small study of acute myeloid leukemia patients, TXA was found to reduce platelet transfusions.[49]


Von Willebrand’s disease

Although evidence from RCTs is lacking, TXA is used clinically by some clinicians to try to control mucocutaneous bleeding in Von Willebrand’s disease.[1,50]


Hereditary Angioedema

TXA has been found to be useful for prophylaxis of hereditary angioedema with normal C1 inhibitor levels. TXA inhibits conversion of plasminogen to plasmin, a step in kallikrein activation and bradykinin formation.[1,51] TXA’s usefulness as a treatment for hereditary angioedema is less important than in the past due to the development of newer and more efficacious medications.


A systematic review of the literature on the use of TXA for hereditary angioedema concluded that there was limited positive evidence for the use of TXA as an acute treatment but that it was inferior to other treatments such icatibant or pdC1INH (subcutaneous plasma‐derived human C1‐Inhibitor concentrate).[52]


The evidence for the use of TXA in long-term prophylaxis for hereditary angioedema was mixed with some trials showing TXA reduced attack frequency or severity and others finding that TXA was ineffective in some patients and was less effective than C1-INH (C1 esterase inhibitor).[52]


For short-term prophylaxis, TXA may be more effective than no treatment and there may be limited effectiveness of TXA in short term prophylaxis prior to dental procedures and minor surgery.[52]


Angioedema from Angiotensin-converting enzyme (ACE) inhibitors.

There are some case reports of TXA being used successfully for ACE inhibitor-related angioedema.[53,54,55]


Hereditary hemorrhagic telangiectasia

Hereditary hemorrhagic telangiectasia or Osler-Weber-Rendu disease is a multisystem disorder of abnormal angiogenesis and is the second most common hereditary bleeding disorder in the world. Most patients with this disorder will develop recurrent epistaxis. Anti-angiogenics, which prevents the growth of new blood vessels, are currently used to reverse underlying vascular defects to prevent bleeding. However, some studies have found TXA to be useful for reducing epistaxis episodes.[1,56,57]


Melasma

Melasma is an acquired condition, seen more commonly in women, where hyperpigmentation of the skin occurs due to ultraviolet radiation sun exposure. Though not a common treatment, TXA injected into the lesions, or administered either topically or orally have been studied as treatments. A meta-analysis and systematic review found that TXA reduced the size of melasma lesions, both alone or in combination with other therapies.[1,58]


Conclusions

TXA is FDA-approved as a treatment for heavy menstrual bleeding and short-term prevention of bleeding in patients with hemophilia after dental extraction. Other uses are considered off-label.[10] TXA has a wide range of indications including trauma, post-partum hemorrhage, excessive uterine bleeding, dental and tonsillar surgery, hemoptysis, angioedema, orthopedic surgery, melasma and possibly epistaxis. Some of the trials were large, such as the CRASH trauma trials, while evidence for TXA use in other conditions is not as robust, coming from case reports or smaller studies.


In some diseases, such as hereditary angioedema, TXA’s usefulness as a treatment is less important than in the past due to the development of newer medications.


In all of the larger studies there was no increased incidence of thrombotic complications with TXA use. Seizures from TXA in cardiac surgery have resulted in the use of lower doses for that indication.


Clinicians should be familiar with the indications for TXA as some of their patients may be taking it prophylactically or may be candidates for its use clinically.


Author’s note: Many treatments using tranexamic acid are considered off-label. Before administering tranexamic acid, clinicians are advised to review doses with existing institutional protocols, other reference sources, or their hospital pharmacist to ensure dosage, method of administration and timing are correct.

 

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