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Blood Coagulation Disorders clinical trials

View clinical trials related to Blood Coagulation Disorders.

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NCT ID: NCT00994045 Completed - Clinical trials for Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair

Fibrinogen as an Alternative to FFP in Aortic Surgery.

Start date: June 2010
Phase: Phase 4
Study type: Interventional

Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated with a large blood loss and potentially life-threatening clotting abnormalities. Theses clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from human blood donations), the administration of which carries a number of risks including virus transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and infection with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to children or high-usage adults in the UK because of the infection risk, and recently it was decided by a UK advisory body that the use of UK-derived FFP should cease. Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less infection risk (purified, heat treated) and has been in licensed use for many years in other European countries. The investigators have been using fibrinogen concentrate recently in their department as an alternative to FFP with encouraging results. 20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as treatment for clotting abnormalities during their surgery. The investigators will take a number of additional blood samples which will provide valuable information about the pattern of clotting abnormalities during this type of operation. The investigators will also record blood loss and the number of allogeneic (derived from human donors) blood components transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess the pattern of coagulation abnormalities in both groups. We will also examine whether the use of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.

NCT ID: NCT00984126 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

Start date: October 26, 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients. The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

NCT ID: NCT00978380 Completed - Clinical trials for Congenital Bleeding Disorder

Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725

mentorâ„¢2
Start date: September 21, 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

NCT ID: NCT00969319 Completed - Hemophilia A Clinical Trials

Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

Start date: September 2009
Phase: N/A
Study type: Observational

The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.

NCT ID: NCT00966290 Completed - Clinical trials for Blood Coagulation Disorders

Anticoagulant Clinics and Vitamin K Antagonists

COMPARE
Start date: February 2003
Phase: Phase 4
Study type: Interventional

Background: Whether the management of vitamin K antagonists (VKA) therapy by general practitioners with the collaboration of anticoagulation clinics (ACC) provides better clinical outcomes than that accomplished by general practitioners alone (usual care [UC] management) is not clear. Objectives: To compare ACC-based shared-care management with UC management of VKA therapy with respect to clinical events. Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at least three months. The primary study outcome is a composite of confirmed symptomatic thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All outcomes are reviewed by a central, independent adjudication committee.

NCT ID: NCT00964353 Completed - Clinical trials for Blood Coagulation Disorders

Clinical and Economic Implications of Genetic Testing for Warfarin Management

Start date: August 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. This study is being done to determine whether providing doctors with data on the genes their patients inherited and warfarin dosing recommendations based on those genes affects the costs and outcomes of care and after hospitalization for patients from different ethnic/racial backgrounds, and how physicians use this information in decision making.

NCT ID: NCT00956345 Completed - Clinical trials for Congenital Bleeding Disorder

Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

Start date: August 2009
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe, Japan and the United States of America (USA). The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.

NCT ID: NCT00953901 Completed - Clinical trials for Surgical Procedures, Minimally Invasive

Is Plasma Transfusion Beneficial Prior to Low-Risk Procedures in Hospitalized Patients With Blood Clotting Abnormalities?

Start date: July 2006
Phase: Phase 3
Study type: Interventional

Blood clotting abnormalities or problems that happen during surgery ? even minor surgery ? are serious because of the possibility of serious bleeding that cannot be stopped. The current standard practice for people with clotting abnormalities is to transfuse additional blood before the surgery, in an effort to decrease bleeding problems. However, transfusing blood before the surgery is not very effective in decreasing bleeding complications. In addition, it may be associated with other complications, including fluid buildup and swelling in the lungs. For this study, a person with a mild clotting problem is defined as one with an INR (International Normalized Ratio) between 1.5 and 3. Severe clotting is defined as an INR greater than 3. This study will aim to test if limiting or restricting transfusion for those patients with severe clotting problems (an INR greater than 3) will result in fewer transfusion problems and fewer unnecessary transfusions in comparison with the current, more liberal, transfusion use for all patients with both mild and severe clotting problems (an INR greater than 1.5).The investigators will also determine if liberal blood transfusion decreases the risk of bleeding after surgical procedures.

NCT ID: NCT00951873 Completed - Healthy Clinical Trials

A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

Start date: July 2009
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).

NCT ID: NCT00951405 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors

Start date: September 1, 2009
Phase: Phase 2
Study type: Interventional

This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.