75 Clinical Trials for Various Conditions
This study will measure in children how much numbing medicine, lidocaine, is absorbed into the bloodstream after it is injected into a blood clot (hematoma) around a forearm fracture for pain control when the broken bone is moved back into place (fracture reduction). This is called a hematoma block and is commonly used in the Emergency Unit. To help with anxiety and to add additional pain control, nitrous oxide (laughing gas) is given while the lidocaine hematoma block is placed and continued during the fracture reduction. Advantages of using this technique for pain control instead of an intravenous anesthetic such as ketamine include faster recovery and discharge home, and longer pain control. Of concern, if too much lidocaine is absorbed into the bloodstream, seizures and irregular heart beating may occur. Bloodstream concentrations of lidocaine after a hematoma block have been measured in only one study of 8 adults and found to be at significant but safe levels. No study has been published in children to measure bloodstream lidocaine levels when a hematoma block is used. Because children's bones are still growing and more metabolically active than adult bones, the investigators believe it is important to determine whether lidocaine blood levels in children are also at safe levels when using a standard lidocaine hematoma block for reduction of fractures. The investigators also want to determine whether bloodstream lidocaine levels correlate with type of fracture. The investigators also aim to determine if there is a difference in absorption pattern between different types of distal radius fractures, if there is a correlation between fracture type and systemic lidocaine absorption, and if there is a correlation between fracture type and ability to provide adequate pain and sedation control with lidocaine hematoma block/inhaled nitrous combination. The investigators believe blood lidocaine levels after hematoma block in children will peak at safe levels, but will be higher than those observed in adults.
Our long-term objective is to evaluate the efficacy of curcumin (CC) in preventing a recurrence of chronic subdural hematoma (cSDH) following surgical evacuation. Recurrence is defined as an increase in total hematoma volume on the operated side compared to a post-operative day one CT scan with persistent or recurrent neurological symptoms. The investigators propose this pilot study to assess feasibility and obtain preliminary benefit assessment of the proposed therapeutic approach. Objective 1: To determine if the use of CC treatment reduces the total hematoma cavity volume over a 6-month interval, compared to a post-subdural drain removal CT scan. This evaluation is expected to offer sufficient evidence for a larger definitive trial. Objective 2: Study the effect of CC on interleukin-8 (IL-8)-induced disruption of endothelial permeability in vitro using human vascular endothelial cells. Central hypothesis: CC treatment prevents the re-accumulation of cSDH, which may occur by inhibition of IL-8 and allowing resolution of the total hematoma cavity volume over six months.
Traumatic and non-traumatic soft tissue hematomas are frequently encountered in the acute care setting. The incidence of these hematomas appears to be on the rise secondary to the increased use of anticoagulants among older patients for a variety of medical conditions. The management of soft tissue hematomas depends on the accurate diagnosis of any ongoing bleeding as well as of identification of the injured vessel type. While the majority of cases can be managed conservatively, expanding hematomas leading to hemodynamic instability or ongoing blood loss might require embolization or surgical intervention. The mainstay diagnostic imaging modality is multidetector computed tomography (MDCT) with intravenous contrast that allows accurate assessment of hematoma size, location as well as evaluation for active extravasation. However, many patients cannot undergo CT imaging due to underlying kidney disease, allergy to contrast, or due to concerns for radiation exposure, especially in young age. Currently there are no alternative tests for these patients with a similarly high diagnostic accuracy available. This study intends to establish an imaging protocol and investigate the utility of contrast-enhanced ultrasound (CEUS) in the diagnostic work-up of soft tissue hematoma as an ionizing radiation-free alternative to computed tomography (CT) that can be used independent from the kidney function of the patient.
The purposes of this study are: 1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma. 2. To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements with different operators and at different centers
The goal of this clinical trial is to test whether infusing bevacizumab into the middle meningeal arteries can be used to treat chronic subdural hematomas (cSDH). The main questions it aims to answer are: * Is bevacizumab infusion safe in cSDH patients? * Is bevacizumab infusion effective in treating cSDH?
The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are: * Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths? * What is the safety of MMAE and conventional open surgery in these patients? Participants will be asked to: * Share their medical history and undergo physical examinations * Have blood drawn * Have CT scans of the head * Answer questionnaires * Undergo MMAE or conventional open surgery * Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety.
This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.
The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD). Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
The investigators objective of this study is to evaluate the effectiveness of hematoma block versus intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures.
Chronic Subdural Hematoma (cSDH) is an extremely common problem, particularly in the aging population, where fluid like collections compress the brain, frequently requiring surgical drainage. After drainage, 25-50% of patients experience post operative neurologic deficits such as weakness or confusion that are often not explained by problems such as seizure, stroke, or mass effect from the fluid and blood. Recent subdural recordings have demonstrated that some of these neurological deficits may be related to waves of spreading depolarization (SD), which cause temporary neurological dysfunction. Our overall objective is to examine the relationship between neurological deficits and SD and to assess feasibility of a pilot trial to determine if a strategy of NMDA-R antagonism can effectively reduce SD and improve clinical recovery.
The purpose of this study is to study the use of a drug, tranexamic acid (TXA) to decrease bleeding and fluid collections in patients undergoing excision of excess lower abdominal skin and soft tissue, otherwise known as a panniculectomy. The use of TXA in this study is experimental. TXA is a medication currently used in many surgical subspecialties to control bleeding. TXA is approved by the FDA as a medication taken by mouth for the treatment of heavy menstrual bleeding and as an injection in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. The use of TXA in this study is experimental, which means it is not approved by the FDA for topical use in decreasing bleeding during and after surgery. The results of this study will help the researchers determine if TXA is effective in decreasing blood loss following surgery. If effective, researchers hope this will result in earlier removal of post-operative drains leading to faster return to work or social activities
The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).
The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)
This study is designed to evaluate the effectiveness of endovascular embolization of middle meningeal artery following evacuation of subdural hematomas (SDHs) to assess rate of recurrence. The historical standard for treatment of subdural hematomas has been surgical evacuation through burr holes or craniotomies. Many of these patients are elderly patients who are high risk surgical candidates. A major concern is SDH recurrence. Recurrences require frequent imaging, and will lead to increased length of hospital stay, increased morbidity,and re-operations. There are increasing number of reports that suggest that a less invasive approach such as endovascular embolization of the middle meningeal artery using standard endovascular materials and techniques may reduce the risk of recurrence. The reported outcomes in the current literature have been very positive when endovascular embolization has been used without surgery or as an adjuvant to surgery. However, there have been no studies directly comparing endovascular embolization following surgical evacuation to assess if this technique can actually reduce the complications of SDHs listed above. The investigators propose to study this treatment process by randomly assigning patients who have undergone surgical evacuation of SDHs into a control and treatment group. The control group will receive standard surgical evacuation of the hematoma. The study group will receive surgical evacuation followed by endovascular embolization.
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma as an adjunct to standard treatments, which include medical management and surgical evacuation.
Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase in morbidity and cost for the elderly. This study identifies risk factors affecting readmission rates for these patients and presents strategies to reduce it.
This study aims to reduce the recurrence rate of chronic subdural hematomas (CSDH) by manipulating the post-operative intravenous fluid use. The hypothesis relies on the relationship between osmolality and volume changes related to osmolality. We will be administering dextrose 5% in 1/4 normal saline (D5 1/4NS) post-operatively to induce brain expansion which can take up the residual CSDH space, to help reduce recurrence rate.
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Duke University Hospital (DUH) who have sustained or who are suspected to have sustained head trauma and have consequently received a brain computed tomography (CT) scan(s).
Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has been attempted with the goal of eliminating the arterial supply to the vascularized membrane. The investigators have recently presented the first known case series of MMA embolization as upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five patients underwent successful embolization of the MMA with subsequent reduction in size or complete resolution of cSDH with no peri-procedural complications. The purpose of this study will be to evaluate the safety and efficacy of MMA embolization compared to traditional surgical management for symptomatic, chronic, and medically refractory SDH. MMA embolization is an established procedure used routinely for treatment of tumors or vascular malformations; this study investigates the use of an established procedure for a new disease. The investigators hypothesize that MMA embolization will afford a particularly fragile patient population an alternative to invasive and morbid neurosurgical intervention.
The primary objective of this study is to determine whether a patient with a tibial plateau fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic analgesia requirements following an intra-articular injection of local anesthetic and aspiration of the knee.
This is a single center single arm study of 50 patients to 1) determine the safety of tranexamic acid in the chronic subdural hematoma population following surgical drainage of chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be compared to historical controls. This study intends to be a prerequisite to a large nationally funded randomized control trial.
The purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal radius fracture reduction.
This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density (OD) measurement with an Infrascanner device accurately identifies the presence of an intracranial hematoma in pediatric patients ≤18 years of age after known or suspected traumatic brain injury compared with head computerized tomography (CT) scans as the gold standard.
Chronic subdural hematoma (cSDH) is condition where blood has slowly leaked out of small blood vessels surrounding the brain. Over time, the blood may cause a variety of symptoms including headache, confusion, limb weakness, and difficulty speaking. There is currently no agreement among physicians as to the best way to treat this condition. The study hypothesis to be tested was: For patients with unilateral, symptomatic chronic subdural hematoma, there is no difference in clinical outcomes, as measured by achievement of modified Rankin Score of 0-2 at 6 months, between those treated with a 2 week course of oral dexamethasone, compared with those treated with burr hole surgical drainage.