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Hemostatic Disorders clinical trials

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NCT ID: NCT02561026 Recruiting - Clinical trials for Blood Coagulation Disorders

Transfusion of Plasma Prior to Invasive Procedures Pilot Trial (TOPPIT)

TOPPIT
Start date: January 2016
Phase: Phase 3
Study type: Interventional

Frozen plasma (FP) is commonly transfused to patients with abnormal coagulation results prior to medical procedures associated with a risk of bleeding (e.g. involving a needle or incision). The most frequent group that requires FP transfusions are patients admitted to an intensive care unit. These patients frequently have abnormal coagulation tests and also frequently require invasive medical procedures that can be associated with bleeding. While FP transfusions can improve abnormal coagulation test results, there is no evidence to suggest that prophylactic FP transfusions will reduce bleeding associated with medical procedures in patients with mild coagulation abnormalities. Additionally, it is known that important adverse complications occur with FP transfusions. The investigators will undertake a pilot randomized controlled trial in non-bleeding ICU patients who require an invasive medical procedure (central venous catheterization, chest tube, thoracocentesis, paracentesis, biopsy, fluid drainage) in 3 Canadian hospitals. Patients with an abnormal coagulation test (INR between 1.5 to 2.5) will receive a FP transfusion or no treatment prior to an invasive procedure. The primary outcome for this pilot study will be feasibility (the number of patients enrolled per month). Other important outcomes will include those that will be evaluated in the definitive trial including bleeding post procedure, red cell transfusions, adverse transfusion reactions, mortality and hospital length of stay. The objective of the study is to enrol 80 patients over 2 years in 3 Canadian hospitals.

NCT ID: NCT02512250 Recruiting - Clinical trials for Hemophilia and Other Severe Bleeding Disorders

Swiss Hemophilia Registry

Start date: May 2015
Phase:
Study type: Observational [Patient Registry]

The Swiss Hemophilia Registry will collect data on the prophylactic and therapeutic use of factor concentrates in patients with hemophilia and other severe bleeding disorders in Switzerland.

NCT ID: NCT02379104 Recruiting - Clinical trials for Blood Coagulation Disorders

ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals

ROSI-EVA
Start date: October 2017
Phase: N/A
Study type: Observational

ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta. Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality. Confirmation of reference intervals of the ROTEM® systems.

NCT ID: NCT02324517 Recruiting - Severe Hemophilia Clinical Trials

Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders

Start date: March 2010
Phase: N/A
Study type: Observational

Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.

NCT ID: NCT02293759 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile. Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated with greenlight PVP

NCT ID: NCT02281240 Recruiting - Clinical trials for Hemostatic Disorders

Hemostatic Complications in Hematopoietic Stem Cell Transplantation

HCIHSCT
Start date: December 2014
Phase: N/A
Study type: Observational

Hemostatic disorders are common and potentially fatal complications in patients undergoing hematopoietic stem-cell transplantation (HSCT). Limited data exist on early diagnosis and prevention of these complications. The investigators undertook this prospective study to determine the incidence, predictor factors, specific pathogenesis, management and survival specially for patients with thrombotic and bleeding complication to better improve outcomes.

NCT ID: NCT02239991 Recruiting - Liver Cirrhosis Clinical Trials

Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant

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

A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.

NCT ID: NCT02172833 Recruiting - Infection Clinical Trials

Antibiotic-associated Coagulopathy

Start date: January 2014
Phase: N/A
Study type: Observational

Over the past few decades, a good number of studies with regard to coagulopathy and increased bleeding tendency which is defined as macro- or microscopic hemorrhage, declination of hemoglobin level, thrombocytopenia, and hypoprothrombinemia potentially caused by the use of antibiotics through a variety of suggested mechanisms, including myelosuppression, immune-mediated destruction of thrombocytes and coagulation factors, and suppression of vitamin K epoxide reductase or vitamin K-dependent γ-glutamate carboxylase which may lead to inhibition of biosynthesis of coagulation factor II, VII, IX, and X, have been reported or published. Nevertheless, many of them are case-series studies or case reports with low level of evidence, and there have been no large-scale retrospective cohort studies regarding antibiotic-associated coagulopathy being published. Moreover, in addition to exposure to antibiotics, there are several risk factors, including severity of illness, hepatic or renal function, nutrition status, comorbidities such as cancer and hematologic disease, surgery or other invasive procedure, concomitant use of anticoagulants, NSAIDs, and salicylates, and age, which may exert influence on the function of the coagulation system as well. Therefore, the study aims to clarify the association between the use of antibiotics and the increase of bleeding tendency or the development of bleeding event and to identify possible risk factors of the increase of bleeding tendency or the development of bleeding event in patients receiving antibiotic treatment through the application of nested case-control design and the usage of both the National Health Insurance Research Database (NHIRD) and medical records in National Taiwan University Hospital during the time period from January, 1995 to December, 2013.

NCT ID: NCT01930916 Recruiting - Clinical trials for Blood Coagulation Disorders

Accuracy of a Portable International Normalized Ratio Monitor in Elderly Patients

AGINR
Start date: October 2012
Phase: N/A
Study type: Interventional

Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the treatment of thromboembolic disorders, which are among the most costly diseases in terms of public health resources. According to the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA in 2008 (more than 1% of the French population). VKA are at the origin of many adverse effects, given their narrow therapeutic window. They are the cause of the death of approximately 5000 patients per year. The use of this therapy is a priority axis of reflection for the Haute Autorité de Santé. The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people, is particularly affected by this problem. University hospitals of our interregion, given their very substantial regional referral activity, are actually involved in managing VKA adverse side effects. Elderly population constitutes the majority of prescriptions. The main objective of this study is to compare INR of people older than 75 years measured by traditional method with those measured by capillary method with INRatio2 supply. The secondary objective is to show that this measure is not affected by the presence or absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as to test the variability of INR measurement between different hospital.

NCT ID: NCT01912547 Recruiting - Mesothelioma Clinical Trials

Thromboelastography During Surgery for Malignant Pleural Mesothelioma

Start date: September 2013
Phase: Phase 0
Study type: Observational

Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.