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Hemorrhage clinical trials

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NCT ID: NCT06170619 Not yet recruiting - Bleeding Clinical Trials

Obsidio™ Conformable Embolic Registry

OCCLUDE
Start date: May 2024
Phase:
Study type: Observational [Patient Registry]

OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio.

NCT ID: NCT06166771 Not yet recruiting - PPH Clinical Trials

Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage

"Alma system"
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Prospective, non-randomized, feasibility pilot study Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur immediately after vaginal birth or cesarean section. In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth. Prospective, non-randomized, feasibility pilot study The purpose of this study, clinical trial, is to obtain information on the safety and effectiveness of the investigational new medical device - Alma System,. Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage. The main questions are: 1. Rate of device related SAE up to six weeks following device treatment. 2. Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure. 3. Rate of occurrence of uterine inversion of folding during or immediately after device procedure. main tasks for participants: - sign the informed Consent form and enrolment - In case of PPH, treatment with Alma - Participate in 2 visit followup After the treatment- 1st upon discharge and 2nd after 8 weeks.

NCT ID: NCT06157307 Not yet recruiting - Clinical trials for Postpartum Hemorrhage

Four Different Methods of Performing External Aortic Compression After Caesarean Section

KEXAC
Start date: November 30, 2023
Phase: N/A
Study type: Interventional

After childbirth, bleeding from the uterus occurs, which can quickly become very profuse if the uterus does not contract. Annually, around 80000 women die because profuse bleeding associated with childbirth, mainly in low -and middle income countries. By pressing a fist on the outside of the abdomen in the umbilical plane (aortic compression) the abdominal artery is compressed, which directly reduces the bleeding from the uterus and any bleeding from the birth canal. The goal of this small clinical trial is to compare four different ways of performing aortic compression in healthy women directly after a planned uncomplicated cesarean section. The main questions aim to answer are: - Is there a difference in how well aortic compression works, defined as cessation of blood flow in the inguinal artery measured by ultrasound, when applying aortic compression with the fist positioned in the transverse plane or longitudinally, compared to the fingertips and a fist protector - Does the researcher experience a difference between the four different methods? The study takes place in the operating room immediately the cesarean sectio is complete. The participant will then still have the effect of the spinal anesthetic. The researcher begin the trial by recording vital signs: heart rate and electrical activity, blood pressure and the amount of oxygen in the blood. Ultrasound will be used to see the blood flow in the right inguinal artery. If everything is normal, the researcher will apply aortic compression in four different ways. The researcher will start aortic compression with the fingertips, then with a fist placed lengthwise. After that with the fist across the abdomen and then with a fist protector. At each occasion there will be a maximum of 5 seconds of total occlusion of the abdominal artery. Cessation of blood flow in the inguina artery becomes the criterion for total compression of the abdominal artery below the umbilicus. After the trial, the participant will be transferred to the post-operative ward, where, in addition to standard monitoring, you are also observed for 30 minutes by of the researcher. The study is carried out at Karolinska University Hospital and takes approximately 20 minutes, including preparation. There are no clinical benefits for the participants. Increased knowledge of different ways of performing aortic compression can contribute to better treatment of women with profuse bleeding after childbirth.

NCT ID: NCT06147531 Not yet recruiting - Cardiac Surgery Clinical Trials

Delayed Cold-Stored Platelets -PLTS-1

PLTS-1
Start date: April 2024
Phase: Phase 2
Study type: Interventional

PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety.

NCT ID: NCT06145568 Not yet recruiting - Clinical trials for Infant, Premature, Diseases

Maternal & Infant Morbidity and Mortality

Start date: December 1, 2023
Phase:
Study type: Observational

The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health. Our hypothesis is that patients with minority status, particularly Black and Hispanic Americans, are more likely to have poor outcomes (based on various health metrics) compared to Non-Black, Non-Hispanic patients. We hypothesize further that it is likely not far off from national trends, which indicate that Black parturients are x4 more likely to die during childbirth, and Black children are 2.4x more likely to die before their first birthday than Non-Hispanic White children. The EPIC database will be used on an institutional basis to obtain information and accessed by UVA statistician to perform the research described in this submission. The dataset does contain a few direct identifiers of medical record numbers, dates, and postal number. We anticipate that all statistical analysis will be performed at UVA by participating faculty/staff.

NCT ID: NCT06141447 Not yet recruiting - Hemorrhage Clinical Trials

Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

Start date: November 20, 2023
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT06134583 Not yet recruiting - Clinical trials for Post-Traumatic Subarachnoid Hemorrhage

Superior Cervical Sympathetic Block Versus Stellate Ganglion Block in Post-traumatic Subarachnoid Hemorrhage

Start date: December 2023
Phase: N/A
Study type: Interventional

Posttraumatic Subarachnoid hemorrhage (SAH) is a life-threatening neurological problem with a high mortality rate. Delayed cerebral ischemia (DCI) is the second-leading cause of death and disability in patients suffering from SAH. DCI is strongly associated with cerebral arterial vasospasm (CAV), which reduces cerebral blood flow (CBF) and causes cerebral infarction. Various treatment modalities have been tried for the prevention and treatment of vasospasm, including oral nimodipine and isovolumic hypertension, as well as endovascular treatments such as intra-arterial drug infusion and balloon angioplasty. A few studies have demonstrated the role of stellate ganglion block (SGB) in the management of this dreaded complication. Cervical sympathetic block (CSB) may be an effective therapy but is not routinely performed to treat vasospasm/DCI. CSB is a local, minimally invasive, low cost and safe technique that can be performed at the bedside and may offer significant advantages as complementary treatment in combination with more conventional neurointerventional surgery interventions. Aim of study is evaluating the effect of superior sympathetic ganglion block versus stellate ganglion block in treating cerebral vasospasm and prevention of delayed cerebral ischemia in refractory post-traumatic subarachnoid hemorrhage.

NCT ID: NCT06132139 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage

VisAR Augmented Reality Navigation of Ventriculostomy

Start date: July 2024
Phase: N/A
Study type: Interventional

This study is intended to evaluate the feasibility of using VisAR augmented reality surgical navigation during placement of an external ventricular drain (EVD). The investigators are interested in confirming the design of the VisAR headset is compatible with this bedside procedure.

NCT ID: NCT06122792 Not yet recruiting - Portal Hypertension Clinical Trials

Preemptive TIPS for Gastric Variceal Bleeding in Patients With Cirrhosis

Start date: January 2024
Phase: N/A
Study type: Interventional

The prevalence of gastric varices is approximately 20%. It is important to note that gastric varices tend to bleed more severely, have a higher morbidity and mortality rate, and have a 35% to 90% risk of rebleeding after the cessation of acute hemorrhage. Because of the relatively low prevalence of gastric varices, the existing clinical studies have many deficiencies, and there is much controversy in the academic community, the optimal treatment and prevention strategies for gastric varices have not yet been fully defined. In the last few years, important advances have been made in the treatment and prevention of gastric variceal bleeding in patients with cirrhosis. Experts agree that the combination of pharmacological and endoscopic injection of tissue adhesives should be the first line of therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2 gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in fundal variceal bleeding showed that an early TIPS, performed during the first 5 days after patient admission resulted in a significant decrease in failure to control bleeding and early and late rebleeding. However, the study was conducted for 4 years and only included 25 patients. Due to insufficient sample size, it was unable to reflect whether priority TIPS can bring survival benefits to patients with gastric variceal bleeding. Therefore, there is an urgent need for multi-center clinical studies with large samples to provide high-quality evidence in the field of prioritizing TIPS for the treatment of acute gastric variceal bleeding. The present study aims to compare the preemptive TIPS (performed during the first 72 hours after endoscopy) with standard second prophylaxis (endoscopic injection of tissue adhesives plus carvedilol) for patients with acute bleeding from gastric varices (IGV1 or GOV2). The primary outcome will be a 6-week mortality from inclusion.

NCT ID: NCT06122753 Not yet recruiting - Portal Hypertension Clinical Trials

Preemptive TIPS for Variceal Bleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis

Start date: January 2024
Phase: N/A
Study type: Interventional

Portal vein thrombosis (PVT) can lead to a further increase in portal venous pressure and increase the risk of rebleeding. Whether patients with acute esophagogastric variceal bleeding with occlusive PVT benefit from preemptive TIPS is still controversial. The present study is directed at comparing the outcome of patients with acute variceal bleeding with occlusive PVT treated by standard therapy (vasoactive drugs + endoscopic variceal ligation) with or without preemptive TIPS (performed during the first 1-3 days after endoscopic procedure). The primary outcome is survival free of variceal rebleeding at 6 weeks from inclusion.