1,263 Clinical Trials for Various Conditions
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.
Abortion, Dilation and Evacuation, Hemorrhage, Prophylactic Tranexamic Acid Use, Blood Loss
This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.
Intracerebral Hemorrhage
The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are: * Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days) * Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding) * Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism) Researchers will compare preoperative TXA to no TXA to answer the above questions. Participants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.
Bleeding, Colorectal Disorders, Thromboembolism, Tranexamic Acid
Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.
Hemorrhage Lung, Endobronchial Mass
Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate GATT concurrently with a progestin. Clinicians who prescribe GATT do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. This study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating GATT with or without concurrent initiation of a progestin contraceptive. The results from this study will enable clinicians to more accurately counsel patients using GATT on how the use of a progestin might affect their bleeding and whether this differs by progestin method.
Gender, Contraception
The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D\&E) in the clinic setting.
Hemorrhage
This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.
Internal Hemorrhoid
Dual antiplatelet therapy (DAPT) is indicated in all patients undergoing coronary stent implantation to prevent ischemic recurrencies despite an increased risk of bleeding. Accordingly, clinical practice guidelines advocate tailoring DAPT duration according to the patient's individual ischemic and bleeding risk profile. Data from 11 clinical trials involving patients who underwent percutaneous coronary intervention (PCI) with an everolimus-eluting stent will be pooled and analyzed to develop a machine learning-based algorithm to predict the probability of an ischemic or bleeding event up to 1 year. These predictive risk models aim to support clinical decision-making on DAPT management after PCI.
Coronary Artery Disease, Percutaneous Coronary Intervention
This randomized double blinded trial seeks to determine whether tranexamic acid (TXA) is an efficacious treatment for contraceptive induced menstrual changes (CIMC) including irregular, bothersome bleeding caused by the etonogestrel subdermal contraceptive implant (ENG implant). Participants will be randomized into the TXA treatment arm or a placebo. They will begin taking the medication after three consecutive days of bleeding. Participants will track their bleeding using an automated text message service
Bleeding, Contraceptive Device; Complications
It is unknown if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for bleeding control. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design.
Hemorrhage, Laceration
The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided. Participants will be given one of the two FDA-approved blood products.
Hypofibrinogenemia, Bleeding
Two strategies have both proven to be effective in reducing bleeding complications while preserving efficacy compared with maintaining long-term DAPT with aspirin and a potent P2Y12 inhibitor: a) DAPT de-escalation (i.e., switching from prasugrel or ticagrelor to clopidogrel while maintaining aspirin) and b) potent P2Y12 inhibitor monotherapy (i.e., maintaining prasugrel or ticagrelor and dropping aspirin). These strategies have been tested in a number of trials and have led to changes in practice guidelines to consider either one of these strategies as bleeding reduction approaches among ACS patients undergoing PCI. However, comparative assessments between DAPT de-escalation and potent P2Y12 inhibitor monotherapy are lacking.
Coronary Artery Disease
The investigators propose to perform serial detailed cognitive, motor, behavioral, and blood collection follow-up using longitudinal structured telephone interviews of an anticipated 350 ICH survivors enrolled in Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation (MISTIE) III and ENRICH trials to identify specific cognitive and motor impairment and to perform RNA sequencing to evaluate for evidence of chronic inflammation. The investigators' expected sample size in 2022 accounts for mortality attrition of 10%/year.
Intra Cerebral Hemorrhage, ICH - Intracerebral Hemorrhage, ICH, Hemorrhage, Stroke, Clot (Blood); Brain, Clot Blood, Cognitive Decline, Cognitive Impairment, Survivorship, Memory Impairment, Motor Activity
The investigators propose prospectively evaluating if adding separate sutures to the angles of the vaginal cuff before running barbed suture reduces the incidence of patient's perception of bleeding after surgery.
Postoperative Bleeding, Patient Satisfaction, Complications, Operative Time
This is a single-site, single-arm, open-label pilot study assessing the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for the acute treatment of aneurysmal subarachnoid hemorrhage (SAH) subjects in a neurocritical care setting. 25 patients will be enrolled, all treated with an active device. The primary efficacy outcomes are reduced aneurysm rupture rate, reduced seizure and seizure-spectrum activity, minimized hemorrhage grades, and increased survival.
Subarachnoid Hemorrhage, Aneurysmal
Early detection of ongoing hemorrhage (OH) before onset of hemorrhagic shock is a universally acknowledged great unmet need, and particularly important after traumatic injury. Delays in the detection of OH are associated with a "failure to rescue" and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. An early alert to the presence of OH would save countless lives. This is a single site study, enrolling 48 patients undergoing liver resection in a "no significant risk" prospective clinical trial to: 1) further identify a minimal subset of noninvasive measurement technologies necessary for the desired diagnostic performance, 2) validate the performance of our Phase I algorithm, and 3) re-train the algorithm to a Phase II human iteration. The main outcome variables are non-invasive measurements that will be used for machine learning, not real-time patient management. The data generated will be used later for discovery and validation in traditional and innovative machine learning.
Occult Bleeding, Hemorrhage, Hemorrhagic Shock
Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D\&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D\&E at 16 to 24 weeks gestation.
Abortion, Dilation and Evacuation, Hemorrhage, Blood Loss
Obstetric hemorrhage is one of the leading causes of maternal death worldwide. One of the challenges in management of hemorrhage is that young, healthy women compensate for blood loss via peripheral vasoconstriction, so they maintain their blood pressure and heart rate at normal levels even after experiencing significant blood loss. By the time vital sign abnormalities appear, interventions must be performed extremely rapidly to avoid organ damage and maternal death. Clinical methods of estimating blood loss in real time, such as visual estimation, are notoriously unreliable, and changes in laboratory testing such as hemoglobin levels lag hours behind actual blood loss. A tool which can detect and quantify blood loss in real time, before vital sign changes occur, has the potential to allow for earlier mobilization of resources and intervention in these cases, thus saving lives. This device is meant to detect changes in skin blood flow which reflect vasoconstriction. The investigators believe that this device, therefore, has the potential to be able to detect and quantify blood loss in real-time. However, as this novel device has never been used for this purpose, before undertaking a large clinical trial, the investigators feel it is necessary to perform a pilot study to assess the feasibility and tolerability of this device. The investigators plan to test this by asking 50 patients undergoing planned cesarean section to wear the device during their surgery. The device will collect skin perfusion measurements during the surgery, which will not be available to the operating team. The patients will also be asked to complete a survey regarding their experience wearing the device. The investigators will use this information to ensure that the device is transmitting interpretable data, that patients feel the device is tolerable during surgery, and to ensure that the device can be used in the operating room without any unforeseen logistical challenges which would need to be addressed in planning a larger trial. The investigators will perform a preliminary comparison of sensor readings to laboratory findings, to assist in planning a larger trial.
Hemorrhage, Postpartum, Hemorrhage, Vasoconstriction
This is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure. At least 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. These populations will be enrolled based on separate inclusion criteria.
Hemorrhage, Urgent Surgery, Invasive Procedure
Primary Objective: To identify the optimal interval to restart oral anticoagulation after traumatic intracranial hemorrhage that will minimize thrombotic events and major bleeding by performing a response adaptive randomized (RAR) PROBE clinical trial of restarting in anticoagulant-associated traumatic intracranial hemorrhage patients, comparing restart at 1 week to restart at 2 weeks or at 4 weeks, with a primary composite outcome of major thrombotic events and bleeding. Primary Outcome: 60-day composite of thromboembolic events, defined as DVT, pulmonary emboli, myocardial infarctions, ischemic strokes and systemic emboli, and bleeding events defined as non-CNS major bleeding events (modified BARC3 or above) and worsening index tICrH or new intracranial hemorrhage (ICrH). Secondary objectives of this trial include: 1. To use the Trauma Quality Improvement Program (TQIP) of the American College of Surgeons - Committee on Trauma (ACS-COT), a well-established and highly respected trauma center oversight mechanism, to translate findings of the trial into practice in a closed loop. 2. To establish a relationship between time of restarting and overall secondary events, i.e. a dose response, that favors early restarting (1 week is better than 2 weeks and 2 weeks is better than 4 weeks. 3. To explore patient centered utility weighting of thrombotic versus bleeding composite endpoint components by: A) 60-day Disability Rating Scale (DRS) 24,25 and modified Rankin Scale (mRS)26; B) Trial patient-reported standard gamble utilities including by race, gender and ethnicity. 4. To explore the composite without DVT in the thrombotic component
Hemorrhage, Intracranial Hemorrhages, Bleeding, Trauma
The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant.
Bleeding, Implants, Breakthrough Bleeding
Background: While the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support. This can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies. Purpose: Examine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well. This effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU. In addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty.
Intra Cerebral Hemorrhage, Subarachnoid Hemorrhage, Intraventricular Hemorrhage, Nontraumatic Haemorrhage
"Bleeding in Critically Ill Children with Underlying Oncologic Diagnoses ," will be a prospective observational cohort study looking at the epidemiology of bleeding in the pediatric ICU population at MSK.
Cancer, Bleeding
Patients with cirrhosis are frequently hospitalized and often undergo procedures. Knowledge surrounding bleeding risk is sparse and practice patterns vary across centers in regards to bleeding prophylaxis. The goal of this study to is to obtain more knowledge regarding risk factors for procedural related bleeding in patients with cirrhosis and to develop a predictive model to risk stratify patients before undergoing procedures. Through collaboration from centers across the world this study should provide information on prevalence of bleeding and variation in practice patterns for prophylaxis.
Bleeding, Procedural Complication, Cirrhosis, Liver, Coagulation Disorder, Blood
In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO) surgery. TXA is approved by the Food and Drug Administration (FDA) for the reduction of bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries. As PAO surgery has been associated with significant blood loss when compared to other types of joint surgeries. In order to try and avoid bleeding that may lead to complications, different strategies can be used. In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.
Bleeding
Prospective, observational study of students 6 months after completing a Stop the Bleed course to determine overall ability to effectively use a tourniquet to stop external extremity hemorrhage. Following the release of the Hartford Consensus in October 2015, the American College of Surgeons Committee on Trauma initiated the National Stop the Bleed campaign (2) that among several proactive recommendations was to encourage first responders and the lay public to become trained, equipped and empowered to step forward and intervene in a bleeding emergency. The Stop the Bleed initiative provides baseline education and training in the use of tourniquets to stop extremity hemorrhage when pressure alone does not work. While the program has progressively provided education and training to over 130,000 individuals worldwide there are no recommendations regarding time intervals for refresher training to maintain confidence and competence in the use of tourniquets. The rationale for this study is to ascertain if tourniquet application skills are sufficiently maintained 6 months after participation in a Stop the Bleed course and to provide recommendations for refresher training based on the results.
Hemorrhage
The purpose of this project is to test how ketamine, an analgesics currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.
Hemorrhage, Healthy
The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients
Thrombocytopenia, Hematologic Diseases, Bone Marrow Aplasia
A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
Obstetrical Complications, Hemorrhage, Labor and Delivery
The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).
Cerebral Hemorrhage, Brain Hemorrhage, Cerebral Parenchymal Hemorrhage, Intracerebral Hemorrhage