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Hemostatic Disorders clinical trials

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NCT ID: NCT01897792 Terminated - Coagulopathy Clinical Trials

Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma

Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and E) on the development of coagulation derangements and nosocomial pneumonia after severe trauma in patients.

NCT ID: NCT01889732 Recruiting - Clinical trials for Postoperative Hemorrhage

A Gray Zone Approach of Rotational Thromboelastometry for Predicting Postoperative Bleeding in Cardiac Surgical Patients

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

Rotational thromboelastometry (ROTEM) is reliable point of care management of coagulation disorder undergoing surgery. Recently, there are some reports about prediction of perioperative bleeding using ROTEM. But, the effectiveness of ROTEM for predict bleeding and improve outcomes is still debate. In this retrospective study, the investigators will compare immediate postoperative bleeding with ROTEM parameters using a Gray zone approach, and access the reliability of ROTEM for prediction of bleeding after cardiac surgery.

NCT ID: NCT01882114 Recruiting - Atrial Fibrillation Clinical Trials

Atherosclerosis in Atrial Fibrillation

Start date: November 2007
Phase: N/A
Study type: Observational

The prevalence of metabolic syndrome in patients suffering from non valvular atrial fibrillation is derived from studies regarding recurrences of atrial fibrillation after catheter ablation. Prospective studies in european countries are lacking. Furthermore, the impact of metabolic syndrome on cardiovascular events in patients with non valvular atrial fibrillation is still unknown.

NCT ID: NCT01876745 Completed - Clinical trials for Congenital Bleeding Disorder

A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

Start date: October 7, 2014
Phase: N/A
Study type: Observational

This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.

NCT ID: NCT01862367 Completed - Clinical trials for Congenital Bleeding Disorder

Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

mentor™6
Start date: May 17, 2013
Phase:
Study type: Observational

This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect. The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.

NCT ID: NCT01854476 Unknown status - Bleeding Clinical Trials

Safety and Efficacy Study Comparing Pad-gauze With Anti-fibrinolytic Agent Hemostopan™) to a Regular Pad-gauze

Start date: October 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Patients on chronic treatment with hemodialysis have an arterio-venous fistula which enable the insertion of two large gauge needles. At the end of dialysis the needles are extracted and continuous pressure is needed to stop the bleeding. Time to bleeding cessation is different between patients and may be up to 20 minutes. Acquired coagulopathy in patients on chronic hemodylasis is a well known entity. The coagulopathy is multi-factorial including uremic thrombocytopathia, the presence of anemia, the use of anti-platelets and/or anti-coagulation drugs and the regular use of heparin during dialysis. Tranexamic acid (Hexakapron) is an anti-fibrinolytic drug that has a proven efficacy in reducing blood loss at different clinical settings. The drug may be given systemically (PO/IV) or applied locally on the site of injury. The aim of the study is to assess the efficacy and safety of a pad gauze dressing containing tranexamic acid. Study design: A Double-blind study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular pad-gauze. The type of dressing for each dialysis session will be decided in a random manner. In each dialysis session only one type of dressing will be used for both insertion points. Protocol for applying the dressing: Following the needle extraction either dressing "A" or "B" will applied with slight pressure for 2 minutes. If bleeding stops it will be the end of session. If bleeding persists than another dressing of the same kind is applied with slight pressure for 4 minutes. If bleeding stops it will be the end of session. If bleeding persists than another dressing of the same kind is applied with slight pressure for 6 minutes. If bleeding stops it will be the end of session. If bleeding persists than it will be consider a failure and a regular measures will be used until bleeding stops. Each session will be documented in the patient's case report file (CRF). The primary end point of the study: Time to bleeding cessation

NCT ID: NCT01848002 Completed - Healthy Clinical Trials

Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Start date: May 2003
Phase: Phase 1
Study type: Interventional

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

NCT ID: NCT01847989 Completed - Healthy Clinical Trials

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Start date: January 2003
Phase: Phase 1
Study type: Interventional

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

NCT ID: NCT01830712 Completed - Clinical trials for Congenital Bleeding Disorder

A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors

Start date: April 2011
Phase:
Study type: Observational

This study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency of bleeding episodes and durability of joint surgery.

NCT ID: NCT01826123 Active, not recruiting - Clinical trials for Coagulopathy During Cardiac Surgery

Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study

MultiPOC
Start date: July 2013
Phase: N/A
Study type: Interventional

Recently, the investigators study group showed in a mono center study that Point of Care (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in perioperative care of coagulopathic cardiac surgery patients. The investigators aim to verify the obtained results by conducting this multicenter study.