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Bleeding clinical trials

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NCT ID: NCT01608971 Completed - Bleeding Clinical Trials

Protamine in Cardiac Surgery and Haemostasis

PROTT
Start date: January 2011
Phase: N/A
Study type: Observational

Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a protamine regimen based on the initial heparin dose before CPB might lead to overdose of protamine. In contrast, a protamine regimen based on the actual heparin concentration may avoid this condition. The investigators compare both regimens of protamine dosing in patients undergoing complex surgery with CPB and assess its effect on the amount of protamine given, markers of the coagulation system, utilization of blood products and perioperative blood loss.

NCT ID: NCT01532661 Completed - Bleeding Clinical Trials

National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

NOVO7
Start date: April 2008
Phase: N/A
Study type: Observational

The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa. Those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization. The aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.

NCT ID: NCT01514591 Completed - Bleeding Clinical Trials

Thromboelastography in Non-elective Cesarean Delivery

Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

NCT ID: NCT01500135 Completed - Bleeding Clinical Trials

Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment in Vascular Surgery

VASUS
Start date: March 2012
Phase: Phase 3
Study type: Interventional

Present trial is one of two trials (the other being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support a general hemostasis indication across several surgical procedures and organ systems in the USA. The patient will come for a screening and baseline visit, the day of surgery and follow up visits after 1 months, 3 months and 6 months. The enrollment period is planned for 16 months and 6 months of follow up.

NCT ID: NCT01468597 Completed - Bleeding Clinical Trials

Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

Start date: January 2011
Phase:
Study type: Observational

The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual antiplatelet therapy.

NCT ID: NCT01465503 Completed - Bleeding Clinical Trials

Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients

NAPLESIII
Start date: January 2008
Phase: Phase 3
Study type: Interventional

Bleeding occurring during percutaneous coronary interventions (PCI has now emerged as one of the most common complication of PCI and adversely affect in-hospital, short- and long-term outcome.As bivalirudin proved its effectiveness in decreasing haemorrhagic events during PCI, its administration may be advocated in subjects deemed at high risk of bleeding.Objective of the present trial is to compare the safety and effectiveness of procedural use of bivalirudin in comparison to unfractionated heparin (UFH) in patients undergoing PCI deemed at high risk of procedural bleeding.

NCT ID: NCT01452568 Completed - Bleeding Clinical Trials

Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

Start date: June 2005
Phase: Phase 4
Study type: Interventional

The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial. The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.

NCT ID: NCT01358422 Completed - Bleeding Clinical Trials

Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery

OBTAIN
Start date: October 2011
Phase: N/A
Study type: Observational

Research questions: 1. What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE) associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population? 2. What is the absolute risk increase for clinically significant bleeding during the same period associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population? In brief the design of the study is as follows: - We will study patients undergoing non-cardiac surgery within four years of coronary stenting. - We will record the anti-platelet agents taken by patients before, during and after surgery. - We will record cardiac and bleeding events that occur whilst the patient is in hospital. - We will use the statistical technique of propensity scoring to match patients who have similar risk factors and who received different anti-platelet regimens. - We will compare the incidence of cardiac events and bleeding in the matched groups.

NCT ID: NCT01248351 Completed - Bleeding Clinical Trials

Reversibility of Dual Antiplatelet Therapy by Platelets

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The objective of the study is to test the hypothesis whether or not autologous stored platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed by state-of-the-art platelet function assays.

NCT ID: NCT01242280 Completed - Cirrhosis Clinical Trials

Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding.

Start date: January 2010
Phase: Phase 3
Study type: Interventional

In the last years, important advances have been done in the treatment and prevention of esophageal variceal bleeding. Experts agree that the combination of pharmacological and endoscopic therapy should be the first line therapy in the acute bleeding episode; whereas TIPS (transjugular intrahepatic portosystemic shunt) is considered a rescue therapy. Nevertheless, some patients would require different therapies to act as a "bridge" until definitive therapy can be instituted. Balloon tamponade (using the Sengstaken tube) represents, up to now, the most widely used temporary "bridge" to TIPS. However, balloon tamponade is associated with a high incidence of serious adverse events. Recently, the use of self-expanding metal stents have been introduced in the treatment of acute variceal bleeding showing a very high hemostatic efficacy with no adverse events. The present study is directed to compare the efficacy free of adverse events and mortality of self-expanding metal stents vs balloon tamponade in patients with variceal bleeding refractory to medical and endoscopic therapy.