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Hemorrhage clinical trials

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NCT ID: NCT04188171 Active, not recruiting - Hemorrhoids Clinical Trials

Sclerotherapy With Polidocanol Foam In The Treatment Of Hemorrhoidal Disease In Patients With Bleeding Disorders

Start date: August 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment of hemorrhoidal disease includes a conservative approach (dietary and behavioral measures, venotropic and topical medication), office-based treatments and surgery. Rubber banding is currently considered the instrumental method of choice in the treatment of hemorrhoidal disease grades I to III (Goligher's classification). However, its use in patients with bleeding disorders is not recommended. Sclerotherapy can be performed in these patients since the hemorrhagic risk is very low. The most commonly used agent for sclerotherapy is liquid polidocanol. Polidocanol foam seems to be more effective than the liquid formulation and is safe in the treatment of hemorrhoidal disease even in patients with coagulation disorders. This study is aimed to evaluate the efficacy and safety of polidocanol foam sclerotherapy in the treatment of hemorrhoidal disease grades I to III in patients with bleeding disorders.

NCT ID: NCT04162808 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Bleeding Risk Assessment System for Antithrombotic Therapy of ACS

Start date: January 4, 2018
Phase:
Study type: Observational [Patient Registry]

Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.

NCT ID: NCT04135456 Active, not recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

The Optimal Dose of Mannitol for Intraoperative Brain Relaxation During the Operation of Aneurysmal Subarachnoid Hemorrhage

ODAS
Start date: April 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Aneurysmal subarachnoid hemorrhage (aSAH) tended to lead to a sudden increase in intracerebral pressure (ICP), which can cause decreased cerebral perfusion and transient global cerebral ischemia. Early clipping and coiling of aneurysms and surgical evacuation of intracerebral hematoma were recommended for aSAH patients. However, the high ICP made it difficult to separate the subarachnoid space during the operation. Effective reduction of ICP was the key to the succession of the operation. But there is a lack of consensus on the management of raised ICP in aSAH. Mannitol is widely used to reduce ICP in patients with cerebral edema. The potential mechanism including decreasing the viscosity of the blood improving regional cerebral microvascular flow and oxygenation and increasing intravascular volume due to increased plasma osmolality. The magnitude of the pressure reduction was correlated with the intact intracranial automatic adjustment function. However, the hypochloremic metabolic alkalosis, hypernatremia, hypokalemia and renal failure associated with mannitol overdose must be considered and the effective dose and the duration of its administration were still unknown. The aims of this study were to determine the most appropriate mannitol dose to provide adequate brain relaxation in aSAH patients with the fewest adverse effects.

NCT ID: NCT04114643 Active, not recruiting - Clinical trials for Bleeding in Cardiac Surgery

Factor Replacement in Surgery

FARES
Start date: September 24, 2019
Phase: Phase 2
Study type: Interventional

This is a multicentre, randomized, active-control, pragmatic, Phase 2 pilot study in adult cardiac surgery patients. Two Canadian hospitals will participate, and it is estimated that the study will take approximately 9 months to complete. Approximately 120 bleeding adult cardiac surgical patients who require coagulation factor replacement during cardiac surgery will be included. Patients will be randomized to receive either PCC or FP when the blood bank receives the first order for coagulation factor replacement and deems it to be in accordance with accepted clinical standards. Patients will be treated according to their assigned group on the first and second times when coagulation factor replacement is ordered during the treatment period (24 hours after randomization). For any additional doses (i.e., the third dose and thereafter), patients in both groups will receive FP (in 1U increments at the discretion of the ordering physician). No other aspects of care will be modified. This pilot study aims to select a clinically relevant primary efficacy endpoint for a confirmative Phase 3 study, which will subsequently aim to determine if PCC is non-inferior or superior to FP in terms of effica-cy and safety in bleeding cardiac surgical patients. In the pilot study, safety outcomes will be measured for the first 28 days, which is the duration of participation of each patient in the trial.

NCT ID: NCT04088630 Active, not recruiting - Clinical trials for Intracerebral Hemorrhage

Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

FITCH
Start date: August 7, 2020
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to test the safety and effectiveness of a single dose of fingolimod in patients with primary spontaneous intracerebral hemorrhage (ICH).

NCT ID: NCT03991481 Active, not recruiting - Hemorrhage Clinical Trials

The Cryopreserved vs. Liquid Platelets Trial

CLIP II
Start date: August 17, 2021
Phase: Phase 3
Study type: Interventional

This trial is a phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of surgical bleeding. The aim of the study is to assess the efficacy, safety and cost effectiveness of cryopreserved platelets, compared to conventional liquid-stored platelets, for the management of surgical bleeding. This trial will recruit cardiac surgical patients deemed to be at high risk of surgical bleeding and who may potentially require transfusion of platelets. It is estimated to require 808 high-risk cardiac surgical patients to be recruited, to obtain 202 patients who receive transfused study platelets for surgical bleeding.

NCT ID: NCT03987139 Active, not recruiting - Clinical trials for Subarachnoid Hemorrhage, Aneurysmal

Cerebral Autoregulation in Patients With Aneurysmal SubArachnoid Haemorrhage

CASAH
Start date: June 15, 2019
Phase: N/A
Study type: Interventional

The purpose is, in patients with aneurysmal subarachnoid haemorrhage in the early phase after ictus, to examine the following: 1. The effect of spontaneous and induced changes on the brain's static and dynamic autoregulation calculated by transcranial Doppler (TCD), ICP and MAP (primary purposes) and ICP and PbtO2; 2. The effect of mild hyper- and hypocapnia as well as of mild hyper- and hypoxia on the brain's static and dynamic autoregulation, ICP and PbtO2; 3. The relationship between brain autoregulation, mild hyper- and hypocapnia, as well as of mild hyper- and hypoxia and metabolism in microdialysate on the one hand and the occurrence of DCI during hospitalization and poor neurological outcome one year after ictus on the other.

NCT ID: NCT03985176 Active, not recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage

Start date: June 10, 2019
Phase:
Study type: Observational [Patient Registry]

Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI). In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.

NCT ID: NCT03907735 Active, not recruiting - Post-Abortion Clinical Trials

Oxytocin Receptor Expression in Pregnancy

Start date: June 3, 2019
Phase:
Study type: Observational

This study aims to determine when during gestation oxytocin receptor (OXTR) expression increases in the myometrium, which will contribute new insight to the management of obstetric hemorrhage and our understanding of normal and abnormal labor.

NCT ID: NCT03905031 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Defining the Operating Characteristics of NIRS in the Diagnosis of Pediatric Traumatic Intracranial Hemorrhage

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

In this study, investigators look at a different type of technology that might help to avoid having to perform CT scans in certain patients suspected of having a head injury. Near-infrared spectroscopy (NIRS) uses a specific light wavelength to determine if there is bleeding into the head as a result of trauma. Investigators will study NIRS, using a device called the Infrascanner model 2000, to determine if it is as good at detecting bleeding in the head as CT scan, which is the current gold standard. Investigators will try to determine if NIRS can rule in or rule out bleeding into the head, and perhaps this can help to avoid subjecting these youth to the potentially harmful effects of radiation. Investigators will also study how easy it is to use NIRS so that it might become a standard part of the workup for children with suspected head injury.