Clinical Trials Logo

Hemorrhage clinical trials

View clinical trials related to Hemorrhage.

Filter by:

NCT ID: NCT02146040 Completed - Stroke Clinical Trials

Atrial Fibrillation as a Cause of Stroke and Intracranial Hemorrhage Study (The FibStroke Study)

FibStroke
Start date: October 2013
Phase:
Study type: Observational

The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment in relation to thromboembolic events (stroke, and transient ischemic attacks) and intracranial hemorrhage. Primary Outcome Measures: - Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to diagnosis and anticoagulation treatment of AF during the study period; comparison of complications between those with and without anticoagulation treatment according to CHADSVASc score. Secondary Outcome Measures: - The effect of anticoagulation pauses and INR level on stroke and bleeding risk; strokes within 30 days after anticoagulation pause and the prevalence of stroke and intracranila bleeding in relation to INR level < 2, 2-3 and >3. - Trauma as a risk factor for intracranial bleeding: percentage and risk factors for intracranial bleeding with or without trauma. Type of preceding trauma and type of intracranial bleeding. - The time relation between diagnosis of AF and type of intracranial complications: Kaplan Meier analysis of thrombotic (Stroke/TIA) and intracranial bleeding complications after 1st diagnosis of AF in patients with and without anticoagulation - The risk of stroke and intracranial bleeding in relation to CHADSVASc score, HAS-BLED score and anticoagulation/antithrombotic treatment - Prognosis of stroke and intracranial bleeding: 30-day mortality after stroke and intracerebral bleeding in patients with and without anticoagulation - Factors related to underuse of anticoagulation treatment. Data on reasons for not starting or stopping aticoagulation in those with indication of oral anticoagulation - Operations and procedure as risk factor for stroke: Frequency and type of operations performed < 30 days before stroke. Data on length of perioperative pause in anticoagulation and use of bridging therapy and timiing of stroke are collected. - Cardioversions as a risk factor for stroke: Frequency of stroke and TIA < 30 days after cardioversion in relation to use of anticoagulation and CHADSVASc score - The risk of stroke and intracranial bleeding in relation to type of AF (permanent, persistent, paroxysmal) and concomitant carotid disease Estimated Enrollment: 6000 patients.

NCT ID: NCT02145858 Completed - Hemorrhage Clinical Trials

Prevention of Retained-Blood Outcomes With Active Clearance Technology

Start date: June 2014
Phase:
Study type: Observational [Patient Registry]

Postoperative bleeding is a common consequence after heart surgery which can significantly impact outcomes and costs . When bleeding occurs, reliable postoperative blood evacuation of the pleural, mediastinal and pericardial spaces with chest tubes is imperative to facilitate pulmonary reexpansion and mediastinal decompression as the patient recovers. When postoperative blood evacuation is inadequate, complications from retained blood can result. Clinically, retained blood may be recognized acutely or sub acutely. The acute clinical presentation is usually blood and fresh thrombus around the heart or lungs presenting as tamponade or hemothorax. The subacute clinical presentation is bloody pleural or pericardial effusions. These effusions are often driven by the breakdown of remaining thrombus. Once retained blood occurs, subsequent procedures may be needed to remedy it. Interventions to remove postoperative pericardial and/or pleural fluid or blood and reoperations due to bleeding are captured under a composite termed Retained Blood Syndrome, or RBS. The need for treatment and interventions for these conditions represents an impediment to patient recovery and involves both resource and economic consumption for a heart program and the healthcare system at large. A recent review of the literature indicates that additional procedures for RBS are demonstrated in approximately 15% to 20% of patients after heart surgery. In a prospectively collected US Nationwide Inpatient Sample (NIS) data from 2010, RBS could be demonstrated in 17% of patients. In this analysis, mortality was doubled from 4% to 8%, length of stay was increased by 5 days, and average costs were 55% higher. Patients with RBS, therefore, represent an increased at-risk population for complications and costs. Postoperative obstruction of conventional chest tubes with blood and other fibrinous material in the setting of postoperative bleeding contributes to RBS. In a study of postoperative cardiac surgery patients at the Cleveland Clinic, 36% of patients were found to have evidence of chest tube obstruction. Active Clearance with PleuraFlow has been shown to prevent chest tube clogging, and reduce RBS. The purpose of this registry is to evaluate the effectiveness of the PleuraFlow System, a commercial Class II (US), Class IIb (Canada, Europe, and Australia), in the management of blood evacuation after cardiac surgery.

NCT ID: NCT02141074 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

paradigm™6
Start date: July 2, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

NCT ID: NCT02137850 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

pathfinder™6
Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.

NCT ID: NCT02135627 Completed - Clinical trials for MALIGNANT GASTROINTESTINAL BLEEDING

TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.

Start date: April 2014
Phase: N/A
Study type: Interventional

Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods, and stems from local vessel damage and tumor invasion with associated derangements in the hemostatic system(1, 2). Although conventional endoscopic hemostasis methods improve outcomes in UGIB due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps the lower GI tract, data on their use in hemorrhagic, upper or lower gastrointestinal neoplasms are scarce and associated with varying success in initial hemostasis and high rebleeding rates(3-7). Other recognized single or multimodality treatment approaches include radiation therapy, interventional angiography, and surgery. All exhibit disappointing rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11). Challenges associated with bleeding tumors include hematological derangements such as thrombocytopenia, disseminated intravascular coagulation, and neutropenia, as well as the endoscopic manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13). The recent advent of TC-325 (HemosprayTM) to Canada, Europe and Asia - referred henceforth as TC-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for this refractory clinical entity, with promising uncontrolled observations having just been published by our group(13) and others(14). More robust controlled evaluative data are now needed. We propose to study the use of TC-325 in upper and lower malignant GI bleeding compared to contemporary standard of care, and more specifically seeks funding for a pilot study to inform a subsequent peer-review application for a larger, more definitive randomized clinical trial (RCT).

NCT ID: NCT02133378 Completed - Bleeding Clinical Trials

Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

Start date: March 2014
Phase: N/A
Study type: Interventional

A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to be extremely effective, in addition to traditional means, in terminating bleeding during cardiac operations with control rates as high as 97,5%. The investigators compared such hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized hemostasis routine. Following sample size calculation, in a prospective randomized study design, 100 patients will be treated with Hemopatch and 100 patients will receive traditional optimized hemostasis routine (comparison group). To make the two cohorts as comparable as possible enrollment will be restricted to moderately bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately bleeding transversal aortotomy. Study endpoints are the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding in less than 3 minutes from application) and time required for hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.

NCT ID: NCT02132208 Completed - Multiple Trauma Clinical Trials

Evaluation of the TICCS Capacity to Identify Trauma Patients With Acute Coagulopathy and Massive Bleeding

Start date: January 2012
Phase: N/A
Study type: Observational

A prospective single-centre non-comparative non-interventional open study has been designed to validate, in a target number of 100 trauma patients, the correlation between TICCS evaluated on the site of injury and thromboelastography made on a whole blood sample taken at the latest 30 min after patient's arrival in the resuscitation room. The aim of this study was to evaluate the capacity to discriminate trauma patients suffering from active bleeding and arly acute coagulopathy of trauma and needing Damage control resuscitation from those without this aggravating combination with a new purely clinical easy-to-measure pre-hospital score: the Trauma Induced Coagulopathy Clinical Score (TICCS).

NCT ID: NCT02129010 Completed - Clinical trials for Subarachnoid Hemorrhage

The Pathogenesis of Terson Syndrome and the Role of CSF Tau / Amyloid-ß 40 and 42 in Patients With Aneurysmatic Subarachnoid Hemorrhage

Start date: April 2013
Phase: N/A
Study type: Observational

Prospective clinical study to investigate the pathogenesis of Terson syndrome and the prognostic value of the CSF-biomarkers tau-protein and amyloid-β 40 and 42 in patients with aneurysmatic subarachnoid hemorrhage. Our two hypotheses are as follows: 1. The incidence of Terson syndrome correlates with the initial intracranial opening pressure (measured with extra ventricular drain) 2. The CSF-biomarkers correlate with the outcome assessed at discharge, 3-, 6- and 12-months postictally using Glasgow-Outcome-Scale-Extended (GOSE) and Euro-Qol-5 as well as with complications related to aneurysmatic subarachnoid hemorrhage such as cerebral vasospasm, delayed cerebral ischemia and re-bleed.

NCT ID: NCT02120066 Completed - Clinical trials for Submacular Hemorrhage

Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm

Start date: January 2011
Phase: N/A
Study type: Interventional

Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.

NCT ID: NCT02118038 Completed - Clinical trials for Postpartum Hemorrhage Treated With Sulprostone

Emotional and Cardiac Impact of Postpartum Haemorrhage

HELP-MOM
Start date: November 21, 2014
Phase:
Study type: Observational

To assess the impact and to identify the main risk factors for psychological and cardiac morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum hemorrhage