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Hemostatic Disorders clinical trials

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NCT ID: NCT04140812 Recruiting - Preterm Birth Clinical Trials

Stratifying Risk for Intracerebral Haemorrhage

NEW_STRATEGI
Start date: October 21, 2019
Phase: N/A
Study type: Interventional

This study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the development of brain hemorrhage.

NCT ID: NCT04111120 Recruiting - Cirrhosis, Liver Clinical Trials

Heparin Like Effect in Acute Variceal Bleeding

Start date: November 1, 2019
Phase:
Study type: Observational

This study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients. Thromboelastography (TEG) /Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with cirrhosis who present with acute variceal bleeding, will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and thrombin generation response swill be assessed. Thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.

NCT ID: NCT04046029 Recruiting - Aging Clinical Trials

Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Start date: July 8, 2019
Phase: Phase 4
Study type: Interventional

The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention.

NCT ID: NCT03884725 Recruiting - Clinical trials for Blood Coagulation Disorders

Fibrinogen Concentrate In Children Cardiac Surgery 2

FiCCS2
Start date: March 1, 2019
Phase: Phase 4
Study type: Interventional

The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.

NCT ID: NCT03882593 Recruiting - Clinical trials for Blood Coagulation Disorders

Blood Cell Adhesion to Arterial Filters During Cardiac Surgery

Start date: August 30, 2018
Phase:
Study type: Observational

Cardiopulmonary bypass (CPB) is a unique clinical scenario that results in widespread activation of the hemostatic system. Conventional CPB interferes with normal hemostasis by diluting hemostatic cells and proteins, through reinfusion of shed blood, and through activation on the bypass circuit surface of multiple systems including platelets, the kallikrein-kinin system, and fibrinolysis . Besides, deleterious effects of cardiopulmonary bypass (CPB) are partly sequelae of blood-foreign surface reactions. The arterial filter is the part of the CPB circuit where blood cells are exposed to high mechanical stress and where cellular aggregates may fasten in large quantitiesiec.

NCT ID: NCT03760874 Recruiting - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Research Database

Start date: June 13, 2013
Phase:
Study type: Observational [Patient Registry]

All patients with atrial fibrillation who are treated with vitamin-k antagonists (warfarin, phenprocoumon) or non vitamin K oral anticoagulants (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) in real world settings will be recorded in this register. Within this register a characterization of patients and therapy (with regard to medication, dose and duration) will be done. On basis of defined clinical relevant end points the long-term efficacy and safety will be evaluated.

NCT ID: NCT03572309 Recruiting - Trauma Clinical Trials

Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

TICAF
Start date: July 23, 2018
Phase:
Study type: Observational

The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

NCT ID: NCT03570281 Recruiting - Clinical trials for Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)

Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)

ENCHASE
Start date: June 15, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.

NCT ID: NCT03522636 Recruiting - Trauma Clinical Trials

Rapid Administration of Blood by HEMS in Trauma

RABBIT
Start date: June 1, 2018
Phase:
Study type: Observational

Trauma is a leading cause of death among people younger than 44 years. Five million people worldwide die from trauma annually. Uncontrolled haemorrhage causing traumatic-haemorrhagic shock (THS) is the leading cause of potentially preventable deaths from severe trauma. Uncorrected hypervolaemia and prolonged shock cause severe tissue hypoperfusion, vital organ ischemia and subsequently acidosis. In up to one third of trauma patients, laboratory findings suggest traumatic induced coagulopathy, which is further triggered by loss or dilution of coagulation factors. These patients have a significantly increased morbidity and mortality compared to patients with similar injury patterns without coagulopathy. Minimizing the time to surgical control of haemorrhage is key in order to improve outcome. However, immediate and goal directed volume and coagulation resuscitation including use of blood transfusion is crucial to enable survival until definitive hospital care. The primary objective of this study will be to evaluate feasibility of prehospital administration of 1 unit of human plasma and 1 unit of red blood cells, and explore association of early prehospital transfusion with early outcomes in patients presenting with THS, severe bleeding or peri-arrest state who are matching indication criteria and are transported by Helicopter Emergency Medical Service. Results of clinical examinations and laboratory variables in a group of patients receiving prehospital transfusion will be compared to matched population of patients treated before blood has been available on board. Secondary aim of the study is to detect any potential logistical and/or organisational adverse effects, incl. cost-effectiveness, in a regional trauma system with prehospital times (time of injury to trauma centre) ranging from 45 to 75 minutes.

NCT ID: NCT03347591 Recruiting - Clinical trials for Rare Bleeding Disorders

Rare Bleeding Disorders in the Netherlands

RBIN
Start date: November 7, 2017
Phase:
Study type: Observational

Rationale: Rare bleeding disorders (deficiency of fibrinogen, factor II, V, V&VIII, VII, X, XI, XIII, α2-antiplasmin or plasminogen activator inhibitor 1) are not well defined with respect to their clinical phenotype, laboratory phenotype en genotype. At present, little is known about their clinical presentation, bleeding scores, bleeding episodes, health-related quality of life, laboratory parameters, genetics and current treatment. There are large differences in bleeding tendency and weak correlations with the level of factor deficiencies. Therefore, it is essential to perform thorough research in patients with rare bleeding disorders and perform laboratory and genetic tests, to seek explanations for the variety in clinical phenotype. Objective: The purpose of the RBIN study is to describe the epidemiology, bleeding tendency, laboratory parameters, quality of life and genetics of all known patients in the Netherlands with rare bleeding disorders. In addition, the study aims to examine the relationship between clinical phenotype, laboratory phenotype and genotype. Study design: explorative cross-sectional multicenter observational study Study population: all patients registered in Dutch Haemophilia Treatment Centers with known disorders of the coagulation factors fibrinogen, factor II, V, V & VIII, VII, X, XI, XIII, α2-antiplasmin and plasminogen activator inhibitor type 1, aged 1 years and older. Main study parameters/endpoints: Description of the clinical phenotype, laboratory phenotype, genotype and quality of life. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: participating patients will be invited for one visit to their treatment center in order to draw blood, take a saliva sample and perform questionnaires. This will take approximately 40 to 120 minutes. Since the population of patients with rare bleeding disorders is very small it is important to include all patients, also minors (children <18 years), in the study (around one third of known patients are minors). Therefore, this study may be regarded as group-related. The risk associated with participation is negligible.