20 Clinical Trials for Various Conditions
Tranexamic acid (TxA) is a drug that was approved by the FDA in 1986. It is an antifibrinolytic drug - this means that it is used to promote blood clotting by preventing the breakdown of blood clots that the participant's body naturally forms. TxA is very commonly used to control bleeding in a variety of surgeries, such as orthopedic and gynecologic procedures, and is available in both the injectable (delivering the drug through the veins) and oral forms. However, its use is still not commonplace in the setting of elective breast surgery, because it hasn't been extensively studied in this field. Because it is not currently FDA-approved for use in elective breast surgery, this would make the drug "investigational" for this study. Because of its current use in other fields, TxA seems to have a great deal of potential in reducing the amount of post-operative time that breast drains need to be kept in place, the frequency of adverse events during wound healing such as bleeding and fluid accumulation, and overall fluid drainage amount. This would serve to improve the overall process of post-operative healing following a mastectomy procedure. Currently, the use of TxA is approved through the injectable route at Northwestern, but it is not approved for administration by the topical route. Previous studies have shown that TxA given through the topical route of administration in breast reduction surgery reduced post-surgical drainage and fluid accumulation. In this study, the use of 3% (3 grams of TxA in 100 ml of saline) TxA through the topical route by applying it to the breast wound of one breast as a direct fluid irrigation will be investigated. This will be done as a fluid wash, where the TxA will be in a syringe, and just before wound closure the TxA will be sprayed onto the wound site. The other breast will undergo the same procedure, but will receive normal saline solution instead of TxA. The procedure of interest here is a prophylactic bilateral mastectomy, which is a mastectomy that is performed to prevent the occurrence of breast cancer. The purpose of this study is to test whether applying TxA topically during wound closure in mastectomy procedures will affect the quantity of fluid accumulation and bleeding, and the amount of time that post-operative drains need to be kept in place.
Bleeding after Mohs micrographic surgery for skin cancer is a low risk complication that can occur. This study aims to determine the effect of a drug, often used to reduce bleeding, called tranexamic acid when applied topically to the skin wound after surgery.
This is a randomized double-blind control trial evaluating the use Tranexamic acid (TXA) to decrease blood loss and transfusion requirements in pediatric and young adult cancer patients undergoing a limb salvage procedure that frequently requires perioperative or post-operative transfusions of blood products. Primary Objective * To evaluate the difference in intra-or post-operatively transfused blood volume (mL/kg) for patients undergoing limb salvage procedures of the distal femur or proximal tibia who are randomized to receive perioperative tranexamic acid (TXA) versus placebo. Secondary Objectives * To evaluate changes in platelets and in hemoglobin from pre-op to post-op level for patients randomized to receive perioperative TXA versus placebo. * To evaluate differences in post-operative daily surgical drain output for patients randomized to receive perioperative TXA versus placebo. * To evaluate changes in estimated blood loss (EBL) for patients randomized to receive perioperative TXA versus placebo. * To evaluate the association between the intra-or post-operatively transfused blood volume and estimated blood loss (EBL) for patients randomized to receive perioperative TXA and placebo, respectively. Exploratory Objectives * To evaluate differences in functional outcomes post-operatively for patients randomized to receive perioperative TXA versus placebo. * To explore if significant correlations are observed between parameters reported with rotational thromboelastometry (ROTEM®) and EBL and transfusion requirements in pediatric and young adult patients undergoing limb salvage procedure who are randomized to perioperative TXA versus placebo. * To evaluate differences in the prevalence and management of wound complications such as superficial or periprosthetic infections, wound dehiscence, contact dermatitis, post- operative hematomas, or any other clinically significant wound complication between patients randomized to receive perioperative TXA versus placebo.
The purpose of this study is to determine the need for a blood transfusion during surgery and to evaluate the levels of certain proteins in the blood when given tranexamic acid.
BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative blood loss for various orthopaedic procedures including but not limited to total hip arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in 2013 showed that patients who received TXA showed a significant reduction in post-operative transfusion (20.1% to 7.7%). The procedures the investigators will be evaluating are the intramedullary nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures are similar to the total hip or knee replacement in that they can result in significant blood loss that requires a post operative transfusion. STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative transfusion for acute hip fractures repaired with the following two methods, intramedullary nailing for intertrochanteric fracture and hemiarthroplasty. METHODS: The model for the study is a prospective randomized control trial. Patients will be placed in one of two arms of the study after passing our inclusion criteria. The arms will be for either the intramedullary nailing for intertrochanteric fracture or for hemiarthroplasty. These two categories will be subdivided into those receiving TXA and those not receiving TXA. The patients in each category will have standard post-operative care and laboratory testing. The investigators will record the patients in either arm of the study, whether it be no TXA or TXA, who require post-operative transfusion within 1 week of the operation.
Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12). Primary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to severe TBI will not change the proportion of patients with a favorable long-term neurologic outcome compared to random assignment to placebo, based on the GOS-E at 6 months. Secondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing regimens of TXA: * Clinical outcomes: ICH progression, Marshall and Rotterdam CT classification scores, DRS at discharge and 6 months, GOS-E at discharge, 28-day survival, frequency of neurosurgical interventions, and ventilator-free, ICU-free, and hospital-free days. * Safety outcomes: Development of seizures, cerebral ischemic events, myocardial infarction, deep venous thrombosis, and pulmonary thromboembolism. * Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on TEG. Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg, prehospital intravenous (IV) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown), EMS transport destination based on standard local practices determined to be a participating trauma center. Exclusion: Prehospital GCS=3 with no reactive pupil, estimated time from injury to start of study drug bolus dose \>2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity, acute MI or stroke or known history, to the extent possible, of seizures, thromboembolic disorders or renal dialysis, CPR by EMS prior to randomization, burns \> 20% TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA or other pro-coagulant drug given prior to randomization, subjects who have activated the "opt-out" process when required by the local regulatory board. A multi-center double-blind randomized controlled trial with 3 treatment arms: * Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours. * Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours. * Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
Although procedural abortion in the second trimester is extremely safe, hemorrhage is one of the leading causes of morbidity and mortality. Tranexamic acid (TXA) is used commonly in obstetrics to prevent or manage intrapartum or postpartum hemorrhage and has been associated with decreased mortality and decreased blood loss at the time of birth. Some guidelines are recommending the use of TXA for both the prevention and management of bleeding for abortion care. However, there are currently no published studies assessing the association between TXA and bleeding outcomes for abortion procedures. This study will involve a randomized, placebo-controlled trial of pregnant patients aged 18 and older desiring dilation and evacuation (D\&E) for abortion or fetal demise at 18-24 weeks gestation. The primary aim is to determine whether prophylactic TXA has an effect on the need for additional interventions to control bleeding at the time of D\&E. The secondary aim is to determine whether prophylactic TXA has an effect on the mean quantitative procedural blood loss.
Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic surgery. However, postoperative hematoma is one of the most common complications following BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion, wound healing issues, and unfavorable surgical outcomes. Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. However, despite its consistently reported efficacy, low cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery. The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction mammoplasty. The investigators hope to contribute to the growing body of literature supporting tranexamic acid to reduce unwanted surgical bleeding.
The goal of this investigation is to assess whether or not there is a significant difference in the presence and/or degree of post-operative ecchymosis, pain, and edema between groups of patients undergoing upper lid blepharoplasty with traditional local anesthetic (LA) and those who receive tranexamic acid (TXA) in addition to traditional LA.
The purpose of this study is to evaluate the use of locally injected tranexamic acid (TXA) under the skin during Mohs micrographic surgery for removal of skin cancers in patients on anticoagulation. TXA may be helpful in reducing bleeding and pain during surgery, and may also lead to fewer post-operative complications following surgery such as graft loss, specifically in patients on blood-thinners.
The overall purpose of this study is to evaluate the safety and efficacy of co-administration of tranexamic acid (TXA) with hyaluronic acid (HA) in reducing swelling, bruising and pain after facial injection. This will be done by comparing HA to HA+TXA in participants undergoing facial filler injections. Patients undergoing facial filler injections almost always have the same type of injection performed bilaterally in order to maintain symmetry. This provides a unique opportunity where participants can serve as their own controls. Participants will be injected with HA on half of their face and the other half of the face will be injected with HA+TXA. Swelling, bruising, pain, and overall satisfaction will be assessed using participant self-reported surveys, physician surveys, and review of medical records.
This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).
The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.
Gender affirming surgeries (GAS) have been steadily increasing in the US, with the gender affirming mastectomy (GAM) being the most common surgery performed. Complications associated with these surgeries include hematoma and seroma. Prior studies in orthopedics, plastic surgery, and trauma have shown significant reduction of bleeding and ecchymosis with the use of tranexamic acid (TXA). TXA is a synthetic amino acid that blocks plasminogen conversion to plasmin, to stabilize clot formation. The intravenous (IV) efficacy in reducing hematoma rates has been established in implant-based breast reconstruction, as well as in reduction mammaplasty. However, there are currently no studies investigating the use of IV TXA in patients undergoing GAM. The investigators propose a single-center, prospective randomized control trial to evaluate the efficacy and safety of intravenous tranexamic acid in decreasing hematoma and seroma rates for top surgery patients at UCSF. Patients will be randomized into two groups, an experimental group receiving IV TXA and a control group that will not receive IV TXA. Patients in the experimental group will receive a loading dose of tranexamic acid (TXA) at a concentration of 1g/10ml over a period of 10 minutes, administered immediately following anesthesia induction. Patients will be excluded if they have a history of coagulopathy, bleeding disorders or prior chest surgery. Demographic data, surgical characteristics, and postoperative outcomes will also be recorded and analyzed. The investigators hypothesize that the use of IV TXA will significantly reduce hematoma, seroma, postoperative drain output, and time to drain removal in patients undergoing GAM. Aim 1: To evaluate the effectiveness of IV TXA in reducing intraoperative bleeding, post-operative hematoma and seroma formation, drain output, and time to drain removal in patients undergoing GAM. Aim 2: To compare the incidence of thromboembolic events and wound complications between patients receiving IV TXA and those who do not after GAM.
The purpose of this study is to determine the effect of the early administration of intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb), and frequency of blood transfusions) in women undergoing a myomectomy.
This study will investigate how the use of Tranexamic acid and Bacitracin applied to the bleeding site after the hemodialysis fistula needle is removed will affect Time to Clot and Infection Rate
To our knowledge, no studies examining the use of TXA after shoulder arthroscopy in an outpatient setting have been published. This study will evaluate whether TXA reduces pain as measured by opioid consumption and a visual analog scale for pain (VAS) for the first 72 hours after surgery. Secondary outcomes will examine whether patients were satisfied overall with their postoperative pain control, whether the time to first opioid use is increased, and whether the surgeon perceives improved surgical visualization in patients who received TXA. We will also examine the number of times pump pressure was increased during the procedure to improve visualization.
To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.
Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and EACA provide similar blood decreasing effects following TKA or whether one drug provides a superior effect over the other in reducing patients' blood loss.