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Hemorrhage clinical trials

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NCT ID: NCT06335186 Recruiting - Clinical trials for Upper Gastrointestinal Variceal Bleeding in Cirrhotic Patients

Predictive and Prognostic Significance of Age,Blood Tests,Comorbidities(ABC) Score,Cologne Watch(C-watch)Score and Rockall Score for Risk of Variceal Re-bleeding Among Cirrhotic Patients

Start date: February 10, 2024
Phase:
Study type: Observational

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).

NCT ID: NCT06325501 Recruiting - Myoma;Uterus Clinical Trials

Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy

Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT06320132 Recruiting - Clinical trials for Intracranial Hemorrhages

BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage)

BLANDISH
Start date: March 13, 2024
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT06297954 Recruiting - Clinical trials for Upper Gastrointestinal Bleeding

Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

Start date: March 16, 2023
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT06291415 Recruiting - Hemorrhage Clinical Trials

The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

Start date: April 2, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

NCT ID: NCT06285409 Recruiting - Clinical trials for Postpartum Hemorrhage

Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium

Start date: April 4, 2024
Phase: N/A
Study type: Interventional

This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called "uterine atony", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered. This study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further.

NCT ID: NCT06285396 Recruiting - Clinical trials for Postpartum Hemorrhage

Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study

Start date: March 18, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes. Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH. It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory.

NCT ID: NCT06284642 Recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK)

Start date: March 28, 2024
Phase: Phase 4
Study type: Interventional

The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group. Patients in the treatment group will receive standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection started within 24 hours after aneurysm treatment with 30000 IU urokinase, once a day for 3 consecutive days. Patients in the control group will receive standard treatment with the addition of lumbar drainage combined with intrathecal placebo (0.9%NaCl) injection. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 2 on the modified Rankin Scale (mRS), at 6 months after aneurysmal SAH. Primary outcome will be determined by a member of the Independent Committee on Terminal events.

NCT ID: NCT06283901 Recruiting - Stroke Clinical Trials

Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness

IMPROVE-DOC
Start date: January 2, 2023
Phase:
Study type: Observational

Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome.

NCT ID: NCT06282029 Recruiting - Stroke Clinical Trials

ACT-group for Stroke Survivors (Pilot Study)

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are: - Is the group therapy feasible? - Is the group therapy accepted by stroke survivors and therapists? - Are there first indications on the efficacy of the group therapy to improve mental health? Participants will take part in 8 weekly group therapy sessions of 90 minutes each.