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Blood Coagulation Disorders clinical trials

View clinical trials related to Blood Coagulation Disorders.

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NCT ID: NCT02241694 Completed - Clinical trials for Congenital Bleeding Disorder

To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives

HERO
Start date: November 2014
Phase: N/A
Study type: Observational

This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.

NCT ID: NCT02239146 Completed - Clinical trials for Acquired Bleeding Disorder

Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

Start date: October 2005
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

NCT ID: NCT02207218 Completed - Clinical trials for Congenital Bleeding Disorder

To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan

Start date: August 4, 2014
Phase:
Study type: Observational

This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.

NCT ID: NCT02203968 Completed - Trauma Clinical Trials

Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)

FiiRST
Start date: October 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Trauma is the leading cause of death in people 44 years of age or younger. After major trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting defects is responsible for most of deaths in the first hours of hospital admission. Of note, these bleeding-related deaths are potentially preventable. Accordingly, the initial in-hospital management of severely injured patients focuses on stopping bleeding, replacing blood loss and correcting clotting defects. Recently, animal and human research demonstrated that one of the major clotting defects following injury and bleeding is the drop in blood levels of fibrinogen (a clotting factor), which is detected on hospital admission in severely injured patients. These low fibrinogen levels are associated with increased blood transfusion and death. However, in North America, the standard of care for replacing low fibrinogen requires the use of cryoprecipitate, which is a frozen blood product with long preparation time, and similarly to other blood products, carries the risk of viral transmission and transfusion complications. Alternately, many Europeans countries where cryoprecipitate has been withdrawn from the market due to safety concerns, use fibrinogen concentrate. Fibrinogen concentrate undergoes pathogen inactivation, which is a process to eliminate the risk of transmitting viruses, bacteria and parasites, is likely a safer and faster alternative to cryoprecipitate. In Canada, fibrinogen concentrate is licensed for congenital low fibrinogen only. Although preliminary data suggest that fibrinogen supplementation in trauma is associated with reduced bleeding, blood transfusion, and death, the feasibility, safety and efficacy of early fibrinogen replacement remains unknown. We proposed to conduct a feasibility randomized trial to evaluate the use of early fibrinogen concentrate against placebo in injured patients at our trauma centre. A pilot trial is necessary to demonstrate the feasibility of rapidly preparing, delivering, and infusing fibrinogen concentrate as an early therapy to prevent excessive bleeding in trauma. This feasibility trial will provide preliminary safety and clinical outcome data to inform the design of larger trials; which ultimately aims to prevent bleeding-related deaths in the trauma population.

NCT ID: NCT02187120 Completed - Wounds and Injuries Clinical Trials

Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study)

PATCH
Start date: July 28, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this research is to determine whether giving severely injured adults a drug called tranexamic acid (TXA) as soon as possible after injury will improve their chances of survival and their level of recovery at six months. After severe injury, a person may have uncontrolled bleeding that places them at high risk of bleeding to death. Coagulation (the formation of blood clots) is an important process in the body that helps to control blood loss. Up to a quarter of people that are severely injured have a condition called acute traumatic coagulopathy. This condition affects coagulation and results in the break down of blood clots (fibrinolysis) that can lead to increased blood loss and an increased risk of dying. TXA is an anti-fibrinolytic drug that might help to reduce the effects of acute traumatic coagulopathy by preventing blood clots from breaking down and helping to control bleeding. In Australia, TXA is approved for use by the Therapeutic Goods Administration (TGA) to reduce blood loss or the need for blood transfusion in patients undergoing surgery (i.e. cardiac surgery, knee or hip arthroplasty). Recent evidence from a large clinical trial (CRASH-2) showed early treatment with TXA reduced the risk of death in severely injured patients, however the majority of patients involved in the study were injured in countries where prehospital care is limited and rapid access to lifesaving treatments is limited compared to that available in countries like Australia and New Zealand. It is unclear whether TXA will reduce the risk of death to the same degree when it is given alongside other lifesaving treatments that are available to patients soon after injury in these countries. The hypothesis is that TXA given early to injured patients who are at risk of acute traumatic coagulopathy and who are treated in countries with systems providing advanced trauma care reduces mortality and improves recovery at 6-months after injury.

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

paradigmâ„¢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

pathfinderâ„¢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: 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: NCT02120300 Completed - Clinical trials for Chronic HCV Infection

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

Start date: April 2014
Phase: Phase 2
Study type: Interventional

This study will evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) for participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

NCT ID: NCT02096523 Completed - Clinical trials for Inherited Platelet Disorders

Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder

Start date: November 2016
Phase: N/A
Study type: Interventional

The goal of this study is to identify the platelet defect responsible for the bleeding in families from our inherited platelet disorders Israeli-Palestinian registry. The investigators plan to characterize platelet proteome expression after removing high abundance proteins. The investigators will compare the proteome of sick and healthy members of families with inherited platelet disorders, and identify and validate structural proteins, signaling cascades and biomarkers for detection and diagnosis of unknown platelet disorders. The investigators expect to discover new key findings that allow better understanding of human platelet function and allow better diagnosis and treatment of patients with inherited platelet function disorders.