NEWS HIGHLIGHTSMedia Articles Related to Cyklokapron (Tranexamic Acid)
Xanodyne Announces FDA Approval Of Lysteda(TM) (Tranexamic Acid) For Treatment Of Women With Heavy Menstrual Bleeding
Source: Pharma Industry / Biotech Industry News From Medical News Today [2009.11.17]
Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.
FDA Says Yes to Nonhormonal Menorrhagia Drug
Source: MedPage Today OB/Gyn [2009.11.16]
The FDA has okayed tranexamic acid tablets (Lysteda) for the treatment of menorrhagia, the agency announced.
FDA Approves Lysteda To Treat Heavy Menstrual Bleeding
Source: Endocrinology News From Medical News Today [2009.11.14]
The U.S. Food and Drug Administration approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot. Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods.
Published Studies Related to Cyklokapron (Tranexamic Acid)
Tranexamic acid and aprotinin in low- and intermediate-risk cardiac surgery: a non-sponsored, double-blind, randomised, placebo-controlled trial. [2009.08]
OBJECTIVE: Tranexamic acid has been suggested to be as effective as aprotinin in reducing blood loss and transfusion requirements after cardiac surgery. Previous studies directly comparing both antifibrinolytics focus on high-risk cardiac surgery patients only or suffer from methodological problems. We wanted to compare the effectiveness of tranexamic acid versus aprotinin in reducing postoperative blood loss and transfusion requirements in the patient group representing the majority of cardiac surgery patients: low- and intermediate-risk patients... CONCLUSION: Aprotinin has clinically significant advantages over tranexamic acid in patients with normal renal function scheduled for low- or intermediate-risk cardiac surgery.
Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial. [2009.06.18]
BACKGROUND: Diffuse microvascular bleeding remains a common problem after cardiac procedures. Systemic use of antifibrinolytic reduces the postoperative blood loss. The purpose of this study was to examine the effectiveness of local application of tranexamic acid to reduce blood loss after coronary artery bypass grafting (CABG)... CONCLUSION: Topical application of tranexamic acid in patients undergoing primary coronary artery bypass grafting led to a significant reduction in postoperative blood loss without adding extra risk to the patient.
The effect of an intravenous bolus of tranexamic acid on blood loss in total hip replacement. [2009.06]
Tranexamic acid is a fibrinolytic inhibitor which reduces blood loss in total knee replacement... Our study showed that the administration of a standardised pre-operative bolus of 1 g of tranexamic acid was cost-effective in reducing the blood loss and transfusion requirements after total hip replacement, especially in women.
The effect of tranexamic acid for treatment irregular uterine bleeding secondary to DMPA use. [2009.04]
CONCLUSION: Tranexamic acid was more effective than placebo in short-term treatment of irregular uterine bleeding/spotting associated with DMPA use.
Multisite management study of menorrhagia with abnormal laboratory haemostasis: a prospective crossover study of intranasal desmopressin and oral tranexamic acid. [2009.04]
The optimal management of menorrhagia among women with abnormal laboratory haemostasis is uncertain. In a crossover study, 116 women with menorrhagia [pictorial blood assessment chart (PBAC) score >100], negative gynaecological evaluation and abnormal laboratory haemostasis were randomly assigned to either intranasal desmopressin (IN-DDAVP) or tranexamic acid (TA) therapy for two menstrual cycles...
Clinical Trials Related to Cyklokapron (Tranexamic Acid)
A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery [Completed]
Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac
surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have
developed an alternative dosing schedule for tranexamic acid. The objective of this
preliminary study is to determine if this new dosing schedule can achieve the desired plasma
concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic
acid plasma concentrations relative to the current dosing schedule.
Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery [Completed]
Spinal fusion surgery can be associated with significant blood loss requiring allogeneic
blood transfusion. Tranexamic acid is a synthetic amino acid with antifibrinolytic action
that has been shown to reduce perioperative blood loss in patients undergoing cardiopulmonary
bypass for cardiac bypass surgery, knee replacement and liver transplantation surgeries. The
efficacy of antifibrinolytics for reduction of blood loss in major spine surgery has not been
well studied in adult patients. The objective of this study is to determine the efficacy of
tranexamic acid in reducing perioperative blood loss and blood transfusion in adults
undergoing elective spinal fusion in a larger, multi-centered, randomized, double-blinded,
placebo controlled trial.
Tranexamic Acid in HIp Fracture Surgery (THIF Study) [Terminated]
Tranexamic Acid in Urologic Surgery [Recruiting]
This prospective randomized double-blind placebo vs control study aims at verifying the
efficacy of tranexamic acid administration in reducing perioperative bleeding in patients
undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic
acid administration does not increase mortality, myocardial infarction, deep venous
thrombosis, pulmonary embolism, stroke and renal failure.
200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a
slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by
250 mg/h of tranexamic acid by continuous infusion.
Patients belonging to the control group will receive the same volume of saline infusions.
Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery? [Completed]
To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces
blood loss during head and neck surgery.
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