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Hemorrhage clinical trials

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NCT ID: NCT05893407 Recruiting - Ischemic Stroke Clinical Trials

Brain PERfusion Evaluation by Contrast-Enhanced UltraSound

PerCEUS
Start date: July 21, 2023
Phase:
Study type: Observational

The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims : - to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound. - to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.

NCT ID: NCT05891509 Recruiting - Stroke Hemorrhagic Clinical Trials

DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage

GLAMOR
Start date: August 3, 2023
Phase: N/A
Study type: Interventional

Intracerebral hemorrhage (ICH) is a devastating disease with high early mortality, unfavorable neurological outcomes, and high cost of care. To date, the role of DTI-guided minimally invasive hematoma evacuation in ICH is still uncertain. The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.

NCT ID: NCT05889494 Recruiting - Clinical trials for Postoperative Hemorrhage

Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients

Start date: June 5, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot trial is to test a protocol for a planned Canada-wide clinical trial looking at whether or not the use of a patients own blood works as good as the current standard of care using donated blood products to reduce blood loss in adult patients having heart surgery. The main questions this study aims to answer are: - Is the protocol practical, effective, and efficient. - Does the use of a patients own blood lower the following: bleeding, the amount donated blood products given, and complications. Participants will be separated into two groups by a process that is like flipping a coin. One group will donate blood to themselves in the operating room and get their own blood back after surgery. The other group will be given blood products donated by other humans to treat the bleeding after heart surgery. Researchers will compare both groups to see if patients that get their own blood have fewer donated blood products given at time of heart surgery and have less complications after surgery.

NCT ID: NCT05886127 Recruiting - Biliary Obstruction Clinical Trials

Treatment of Postsphincterotomy Bleeding With a Novel Self-assembling Peptide Hemostatic Gel.

ERCPURA
Start date: August 1, 2022
Phase:
Study type: Observational

The aim of this observational study is to evaluate safety and efficacy of a novel self-assembling peptide hemostatic gel in reduction of bleeding after endoscopic sphincterotomy during ERCP (endoscopic retrograde cholangiopancreatography )

NCT ID: NCT05876741 Recruiting - Upper GI Bleeding Clinical Trials

Validation of Prognostic Accuracy of ABC ( Age, Blood Urea Nitrogen , Co-morbidities ) and Horibe Pre-endoscopy Scoring Systems in Patients With Upper Gastrointestinal Bleeding in Sohag University Hospital .

Start date: February 15, 2023
Phase:
Study type: Observational [Patient Registry]

Upper gastrointestinal bleeding (UGIB) is a common medical emergency with significant morbidity and mortality. Treating physicians are urged to perform rapid diagnosis, careful risk assessment, and effective resuscitation to improve outcomes and limit the risk of complications . Several prognostic scoring systems have been developed to identify high- and low-risk patients presenting with UGIB and are commonly used in emergency departments to classify patients. Identifying low-risk patients who can be treated electively or on an outpatient basis can reduce the burden on physicians, patients, and the healthcare system (Rout et al., 2019). On the other hand, identifying high-risk patients who require immediate hospitalization and intervention can help avoid delays in treatment, thereby reducing morbidity and mortality. By using appropriate risk assessment tools, it is possible not only to predict which patients are at risk of adverse events such as rebleeding or death, but also to make management decisions such as the timing of endoscopy, length of hospital stay, and level of care . Several pre-endoscopy scoring systems have been developed to predict the need for hospital-based intervention (transfusion, endoscopic treatment, radiological embolization, or surgery) and 30-day mortality risk. The pre-endoscopic Rockall score (pRS), the Glasgow-Blatchford score (GBS), and the AIMS65 score are the most widely used scoring systems in clinical practice . The GBS was established as a tool for assessing the need for medical interventions (e.g., blood transfusion, therapeutic endoscopy, or surgery). The pRS and AIMS65 have been shown to predict mortality most accurately among patients with UGIB. In addition, AIMS65 is a simple risk score consisting of easily accessible parameters that was created to improve adherence to risk stratification and facilitate early triage and targeted therapy. However, there are limitations in these scoring systems. The GBS is difficult to calculate in routine clinical practice due to its complex nature . Moreover, the discriminative performance of existing scores for the prediction of mortality is relatively poor . Two new relatively simple scores were developed to predict the outcome in patients presenting with UGIB, the Horibe gastrointestinal bleeding (HARBINGER) score (Horibe et al., 2016), and the Age, Blood tests, and Comorbidities (ABC) score (Laursen et al., 2021). The Horibe score was developed primarily to triage patients presented with UGIB (need for hospital admission, endoscopic intervention), while the ABC score was developed to predict 30-day mortality in patients presenting with UGIB. Both scores demonstrated good performance in studies conducted for their validation and may be superior to the existing pre-endoscopy scores .

NCT ID: NCT05874050 Recruiting - Blood Pressure Clinical Trials

Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.

HemoStopArt
Start date: November 11, 2022
Phase:
Study type: Observational

The objective of this observational study is to examine the impact of augmented arterial pressure during the hemostatic phase of elective supratentorial neurosurgery. The primary inquiries it seeks to address are as follows: 1. Does an increase in systolic arterial pressure prompt a hemostatic maneuver by the neurosurgeon, and does the concomitant mean arterial pressure value influence the frequency of such interventions? 2. How often do postoperative intracranial hemorrhages occur, and how severe are they in relation to the achieved mean arterial pressure value? Participants will be enrolled during the preoperative evaluation, where their arterial pressure values, medical histories, and medication statuses will be recorded. Throughout the induction and maintenance of anesthesia, we will monitor their blood pressure values and document any instances of hypotension or hypertension. During the hemostatic phase, we will elevate the arterial pressure using noradrenaline by up to 10 mmHg above the recorded pressure measured at the inpatient clinic. Subsequently, we will inquire whether the neurosurgeon had to employ any additional hemostatic maneuvers following the increase in arterial pressure. The arterial pressure values will be recorded at the end of the surgery, and the first postoperative CT scan will be examined to identify any cases of intracranial hemorrhage.

NCT ID: NCT05872698 Recruiting - Portal Hypertension Clinical Trials

Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.

BOPPP
Start date: June 1, 2019
Phase: Phase 4
Study type: Interventional

Research has proven that large varices can be treated with beta-blockers (a type of anti-hypertensive medication) to reduce the pressure in the veins. The management of small varices is still uncertain. This study aims to discover if beta blockers can be used in this setting. We hypothesize that beta blockers will reduce the risk of bleeding from small varices from 20% to 10% over a period of 3 years, resulting in significant cost savings to the NHS from better patient outcomes.

NCT ID: NCT05871528 Recruiting - Ischemic Stroke Clinical Trials

Registry of Patients With Remote Posterior cErebral Hemorrhage Following Reperfusion Treatment in Ischemic Stroke

HEROES-CAT
Start date: May 1, 2021
Phase:
Study type: Observational

Introduction Remote cerebral hemorrhage following reperfusion treatment in ischemic stroke is rare (1.3-3.7% of all treated strokes) and is associated with worse functional and vital prognosis. Multicenter observational studies suggest that amyloid angiopathy may be one of the main risk factors for remote hemorrhage. Currently, it is unknown what happens to those patients with remote hemorrhage beyond 3 months of follow-up in terms of risk/benefit balance when receiving antiplatelet or anticoagulant therapy, as well as from a cognitive point of view. Considering an analogy with amyloid angiopathy, the hypothesis is that those patients with remote hemorrhage have a higher risk of intracranial hemorrhage during follow-up when receiving stroke secondary prevention, and will also present greater cognitive deterioration during long-term follow-up. Main Objectives - To explore the frequency and risk factors for intracranial hemorrhage during follow-up of patients with remote cerebral hemorrhage. - To explore the frequency and progression of cognitive deterioration during follow-up in patients with remote cerebral hemorrhage. Methodology Observational, prospective, multicenter registry with a population-based case-control design of consecutive patients with remote hemorrhage following reperfusion therapy in acute ischemic stroke. Inclusion criteria: Diagnosis of ischemic stroke with age greater than or equal to 18 years who has remote cerebral hemorrhage after receiving reperfusion therapy in the acute phase. Exclusion criteria: Lack of basic data (age, sex, neuroimaging data) or telephone for follow-up. The cases will be those patients with remote hemorrhage. For each case included, 4 consecutive controls will be included (2 with local parenchymal hemorrhagic transformation and 2 without hemorrhagic transformation). The data will be filled out within the (Codi Ictus de CATalunya) CICAT registry form (currently mandatory in all stroke centers in Catalonia) to which additional variables will be added. Telephone follow-up will be conducted at 3, 12, and 24 months. Main study variable: - Any type of spontaneous or traumatic intracranial hemorrhage during a 24-month follow-up. - Score on the "Short Informant Questionnaire" scale (a validated 17-question questionnaire to be conducted over the phone, where a score higher than 57 points indicates cognitive impairment). Expected sample size during a 2-year recruitment period: 105-300 patients (considering the participating centers to date). Additional information. This study is endorsed by the "Pla Director de la Malaltia Vascular Cerebral" in Catalonia. Participating Centers. Participation offers have been sent to the 28 hospitals in the hospital network of Catalonia with the capacity to administer intravenous fibrinolysis. Positive responses have been received from 13 of them so far. In case the project is accepted by the (Comité Ético de Investigación Clínica) CEIC Sant Pau, the centers that have not responded will be contacted again to obtain their participation.

NCT ID: NCT05858060 Recruiting - Clinical trials for Subarachnoid Hemorrhage, Traumatic

Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage

OSMO-SAH
Start date: July 10, 2023
Phase:
Study type: Observational

The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question[s] it aims to answer are: • whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients? Participants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.

NCT ID: NCT05856838 Recruiting - Clinical trials for Menstrual Bleeding, Heavy

NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding

RAMBOS
Start date: November 24, 2023
Phase: N/A
Study type: Interventional

Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life. In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified. The National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications. An EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia. The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours) This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout). The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.