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NCT ID: NCT05118048 Terminated - Sepsis Clinical Trials

StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

Start date: January 18, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.

NCT ID: NCT04434001 Terminated - Clinical trials for Congenital Heart Disease

ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery

ZEPLAST-PED
Start date: February 27, 2020
Phase: Phase 2
Study type: Interventional

In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening the postoperative outcome. In the adult patient FFP employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.

NCT ID: NCT04131959 Terminated - Bleeding Clinical Trials

Ticagrelor CytoSorb Hemoadsorption

TISORB
Start date: October 29, 2019
Phase: N/A
Study type: Interventional

TISORB is a study to show that the CytoSorb device removes ticagrelor from blood during surgery in patients who need emergency surgery on their heart. The hypothesis of TISORB is that removal of ticagrelor by the CytoSorb device during surgery will decrease the risk for surgical bleeding from ticagrelor.

NCT ID: NCT03954314 Terminated - Bleeding Clinical Trials

DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

DEPOSITION
Start date: September 17, 2019
Phase: Phase 3
Study type: Interventional

The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.

NCT ID: NCT03902275 Terminated - Bleeding Clinical Trials

Validation of a Quantra Supported Hemotherapy Algorithm in Cardiac Surgery

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to develop a coagulation algorithm based on Quantra POCT for the treatment of coagulopathic cardiac surgery patients.

NCT ID: NCT03330457 Terminated - Bleeding Clinical Trials

A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing

Start date: August 6, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, single center study in healthy volunteers dosed to steady state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and tolerability of andexanet vs. placebo (3) Determine the PK properties of andexanet and betrixaban (4) Determine the PD properties of betrixaban before, during, and after receiving andexanet or placebo and (5) Investigate the immunogenicity of andexanet in the presence of betrixaban.

NCT ID: NCT02872649 Terminated - Bleeding Clinical Trials

Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)

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

Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct thrombin inhibitor dabigatran may represent an alternative to Coumarin for long-term anticoagulation. In this pilot single-center study, thirty LVAD patients with stable renal function were scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after implantation of a HeartWare HVAD system following an open-label balanced parallel group design.

NCT ID: NCT02150447 Terminated - Gastric Cancer Clinical Trials

The Use of Proton Pump Inhibitor on the Prevention of Gastric Cancer Bleeding

Start date: June 2009
Phase: Phase 3
Study type: Interventional

The aim of this study is the effect of proton pump inhibitor (PPI) with respect to gastric cancer bleeding in inoperable patients.

NCT ID: NCT01530399 Terminated - Bleeding Clinical Trials

Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the study is to define minimally effective dose of MDCO-2010.

NCT ID: NCT01218074 Terminated - Bleeding Clinical Trials

Platelets Antiaggregation Control Enhancement (PACE) Study

PACE
Start date: December 2010
Phase: N/A
Study type: Interventional

Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.