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Bleeding clinical trials

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NCT ID: NCT02350101 Completed - Bleeding Clinical Trials

Massive Transfusion Protocol With Coagulation Algorithm

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

In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM. Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution.

NCT ID: NCT02329327 Completed - Bleeding Clinical Trials

A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)

Start date: April 10, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.

NCT ID: NCT02279186 Recruiting - Bleeding Clinical Trials

Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section

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

In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.

NCT ID: NCT02264730 Recruiting - Bleeding Clinical Trials

ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered

Start date: July 2014
Phase: Phase 1
Study type: Interventional

Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.

NCT ID: NCT02247128 Completed - Stroke Clinical Trials

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

POPular-TAVI
Start date: January 2014
Phase: Phase 4
Study type: Interventional

At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk. We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).

NCT ID: NCT02245854 Completed - Bleeding Clinical Trials

Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps

Start date: September 2013
Phase: N/A
Study type: Interventional

Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality. Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant. Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps. To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed. Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials. Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy. The investigators perform this study to assess both the efficacy and safety of a novel snare (Exactoâ„¢) for polyp removal.

NCT ID: NCT02244853 Active, not recruiting - Stroke Clinical Trials

Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease

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

The Cardiovascular disease research using Linked Bespoke studies and Electronic Records (CALIBER) e-health database was the data resource for this study. CALIBER links patient records from four different data sources: Clinical Practice Research Database (CPRD), MINAP (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES), the Office for National Statistics (ONS).

NCT ID: NCT02220725 Completed - Bleeding Clinical Trials

A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.

NCT ID: NCT02207725 Completed - Bleeding Clinical Trials

A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban

Start date: March 2014
Phase: Phase 3
Study type: Interventional

The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban.

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.