View clinical trials related to Hemorrhage.
Filter by:In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following: - The robotic stabilizer (prototype - FAMHP approval received) - 41G subretinal needle (CE marked - used within label) - Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes. As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review.
The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization.
Introduction Portal hypertension is a common complication of liver cirrhosis and is often underestimated in clinical diagnosis. The incidence of portal hypertension is approximately 20% to 98% in patients with cirrhosis (Wu et al., 2022). It is the major driver in the transition from the compensated to the 'decompensated' stage of cirrhosis, defined by the presence of clinical complications, including ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, and hepatic encephalopathy (Berzigotti., 2017). Acute variceal bleeding is one of the most lifethreatening complications of liver cirrhosis. Twenty two percent to sixty one percent of cirrhotic patients receiving primary prophylaxis will develop first variceal bleeding during the first two years of follow up. Furthermore, variceal bleeding is associated with high risk of rebleeding and mortality (Tantai et al., 2019). Patients with cirrhosis, although much progress has been made in diagnosis and treatment using vasoactive drugs, preventive antibiotics, early endoscopy and interventional radiology, the 6-week mortality rate remains high, ranging from 10 to 20%, mainly due to failure to control bleeding in the first days. Therefore, the prognostic method of patients with acute variceal bleeding is to determine the risk of rebleeding and resistance to standard treatment (accounting for 20-30%) and mortality rate in order to be able to adopt more aggressive treatment measures. The prognosis is very important but also difficult, not only because of the bleeding status but also depending on the severity of the underlying cirrhosis (Huy et al., 2023). Many risk factors are known to influence the outcome in Upper Gastrointestinal Bleeding (UGIB) setting: Age, comorbidities, presence of shock, endoscopic diagnosis, haemoglobin values at the time of bleeding, stigmata of recent haemorhage and need for blood transfusion have all been described as significant risk factors for rebleeding and death (Monteiro S et al., 2016). Many risk assessment score systems, including pre-endoscopy and post-endoscopy evaluations, have been developed to predict outcomes such as the need for hospital-based intervention, endoscopic therapy, and admission to an intensive care unit (ICU), rebleeding, and mortality. Some studies showed that these scoring systems distinguish low-risk patients who can potentially be managed as outpatients, allowing more efficient use of resources. Other studies suggested that these score systems distinguish higher-risk patients who might require emergency endoscopy or management in an intensive care unit (Li et al., 2022). In 1993, the Rockall Scoring system was introduced to predict the mortality after UGIB and was validated for its use to identify the patients at high risk for re-bleed and mortality. Complete Rockall scoring system is based on an initial clinical score at the time of admission which consist of age (score 0-2), presence of shock (0-2), co-morbidities (score 0-3) and post endoscopic diagnosis (score 0-2) with stigmata of recent hemorrhages (score 0-2). Both clinical and post endoscopic scores added together gives a complete Rockall score with maximum score being 11 (Dewan et al., 2018). In 2020, Laursen S.B. and colleagues conducted a multicenter international study and developed a new prognostic scoring system for UGIB called the ABC score. This scoring system is based on three criteria: age, blood test results, and comorbidities. The score ranges from 0 to 18 points, categorizing the risk into low (≤3 points), moderate (4-7 points), and high (≥8 points) levels. The 30-day mortality rates for high-risk UGIB patients in these three risk groups were 1%, 7%, and 25%, respectively ( Ky et al., 2023) The new Cologne Watch (C-Watch) score was designed as a pre-endoscopic score for acute variceal and non-variceal UGIB and incorporates laboratory values only (c-reactive protein, white blood cell count, alanine-aminotransferase, thrombocytes, creatinine, and hemoglobin) with a minimum point value of 0 and a maximum point value of 8. Within the validation set, it predicted a composite endpoint consisting of recurrent bleeding, need for intervention (interventional radiology, surgery), or death within 30 days with an area under the receiver-operating characteristics curve (AUROC) of 0. About 38.7% of patients were within the high-risk group, i.e., ≥2 points, reached the composite endpoint, whereas no patient classified as low risk (≤1 point) (Allo et al., 2022).
To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.
Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion. Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps. Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia. Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.
The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis. Participants will be treated as per standard clinical practice.
This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs.
The objective is to create a dynamic clinical prediction model that includes routinely measured care and biological biomarkers to predict cerebral vasospasm within 14 days of bleeding in patients treated in the neurosurgical intensive care unit for subarachnoid hemorrhage. Patients admitted to intensive care will be followed for up to 14 days (D14 time horizon of interest), or until discharge from intensive care if earlier. Blood samples will be taken from D1 to D10 to isolate the blood biomarkers of interest for each patient. The measurement of biomarkers and cerebral vasospasm will be blinded to each other.
A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 12 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale.
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.