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Hemorrhage clinical trials

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NCT ID: NCT05622461 Recruiting - Clinical trials for Traumatic Brain Injury

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

Start date: February 13, 2023
Phase: N/A
Study type: Interventional

This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).

NCT ID: NCT05620355 Recruiting - Uterine Fibroids Clinical Trials

Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.

Start date: December 16, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

NCT ID: NCT05617833 Recruiting - Clinical trials for Intraventricular Hemorrhage of Prematurity

Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage

SCEMPI
Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious are severe intraventricular hemorrhage (sIVH) and the subsequent progression to posthemorrhagic hydrocephalus (PHH). Currently, the only treatment for PHH is surgery, most commonly with shunts that are prone to malfunction across the lifespan. Preclinical data show that melatonin (MLT) and erythropoietin (EPO), when administered in a sustained dosing regimen, can prevent the hallmarks of progression from early postnatal sIVH to subsequent PHH. The investigators will perform a Phase I, single institution, randomized, double-blind trial for very preterm infants with sIVH to define a safe combination dose of MLT and EPO. A maximum of 60 very preterm neonates with sIVH will be enrolled, treated through 33w6/7d, and followed to 37w6/7d. Neonates will be randomized 3:1 between MLT+EPO and placebo, with all receiving standard of care. The primary endpoint is a composite serious adverse event (SAE)/dose limiting toxicity (DLT). The investigators hypothesize that the MLT+EPO SAE/DLT rate will not be higher than the placebo rate. Secondary outcomes will be rate of co-morbidities of preterm birth. Exploratory data, collected to guide design of future clinical trials for efficacy, will include serial neuro-imaging metrics acquired from clinical images, serial neonatal neurodevelopmental examinations, serum and urine MLT and EPO levels, and liquid biomarkers. Successful implementation of this initial safety trial will provide essential data to guide the next stage of clinical trials to test if sustained MLT+EPO treatment can reduce the need for surgical intervention, and avoid the lifelong burden of shunted hydrocephalus.

NCT ID: NCT05613309 Recruiting - Clinical trials for Acute Variceal Bleeding

Clinical Characteristics Analysis and Prediction Model Establishment of Fatal Esophageal and Gastric Variceal Bleeding

Start date: December 1, 2022
Phase:
Study type: Observational

The purpose of this study is to analyze the clinical characteristics of patients with fatal acute variceal bleeding (AVB) and establish a mortality risk prediction model to identify patients at high risk of death after admission, so as to guide clinical practice, further optimize the allocation of emergency resources, and further reduce the mortality of AVB patients.

NCT ID: NCT05609110 Recruiting - Clinical trials for Intracranial Hemorrhages

Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage

Start date: February 2, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in treating acute intracerebral hemorrhage.

NCT ID: NCT05604404 Recruiting - Clinical trials for Subarachnoid Hemorrhage, Aneurysmal

Effects of Head-of-Bed on Intracranial Pressure

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

The purpose of this study is to evaluate how pressure inside the skull responds to position changes in patients with brain bleeds.

NCT ID: NCT05598502 Recruiting - Clinical trials for Post-partum Hemorrhage

REBOA in Life-threatening Postpartum Hemorrhage (PPH) in Uganda

REBOA-PPH
Start date: January 17, 2024
Phase: N/A
Study type: Interventional

Background Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum haemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda. Large parts of the monitoring of mothers during active management of third stage of labour is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. A balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of balloon occlusion time including repeated short balloon deflations. Objective To assess the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda. Study design, setting and population A phase IIb/III, open label, 1:1 randomized clinical trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda, to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care. The inclusion criteria are: a) women with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg, b) written consent. The exclusion criterion is prior cardiac arrest or intra-abdominal pregnancy. The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 50% and 85% of the total sample size, and a final analysis with full sample size. Utility of the study It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum haemorrhage in Uganda and the rest of the world.

NCT ID: NCT05589103 Recruiting - Head Trauma Injury Clinical Trials

Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.

Trauma-Head
Start date: January 1, 2020
Phase:
Study type: Observational

The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments. The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin. The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.

NCT ID: NCT05588037 Recruiting - Cataract Clinical Trials

Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Based on the progress of cataract surgery, intraocular lens development, vitreoretinal surgery and anesthesia technology in recent years, the purpose of this study is to develop a new type of more accurate and minimally invasive combined surgery for cataract and fundus diseases, and to evaluate the advantages and value of the surgery as well as related complications, so as to minimize the surgical trauma and obtain faster visual function recovery and better patient comfort. To provide new solutions for the growing demand of eye health care.

NCT ID: NCT05582707 Recruiting - Clinical trials for Intracerebral Haemorrhage, Intraventricular

Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone

ENRICHPLUS
Start date: May 8, 2023
Phase: Phase 2
Study type: Interventional

This is an exploratory single-center prospective study of 20 subjects with primary basal ganglia ICH who will receive early MIPS in combination with perioperative pioglitazone treatment. Outcomes will be compared to matched subjects with basal ganglia ICH who undergo MIPS alone as part of the ENRICH trial. This study will take approximately two years to complete.