Transcatheter Aortic Valve Implantation Prosnosis and Complications

patients will be asked for a venous blood sample

venous blood withdrawl

Tel Aviv Medical Center

Tryptase Level as a Marker of Complications in Transcatheter Aortic Valve Replacement

Tryptase Levels as a Marker of Mast Cell Activity and the Prognostic Implication in Patients Post Transcatheter Aortic Valve Replacement

Post procedural complications - major stroke, acute kidney injury, paravalvular regurgitation, permanent pacemaker implantation, coronary artery obstruction, heart block, vascular injury, pericardial hemorrhage

Only the principle investigator will have access to IPD

Tel-Aviv Sourasky Medical Center

Data will be collected and analyzed from childrens with SIRS or septic state who will be admitted to the Department of Anesthesia and Intensive Care of the University Children´s Hospital Brno, Czech Republic. Infections, sepsis, severe sepsis, septic shock and multiple organ dysfunction syndrome (MODS) will be defined according to commonly used criteria - by International pediatric sepsis consensus conference.

The samples children undergoing elective surgery will be used as a controls, i.e. samples from patients without signs of infection.

Sepsis Syndrome

Treatment of sepsis varies depending on the site and cause of the initial infection, the organs affected and the extent of any damage

therapy sepsis

Faculty Hospital Brno

Utility of Presepsin in Children Sepsis

Diagnostic and Prognostic Utility of Presepsin for Sepsis and Systemic Inflammatory Response Syndrome in Children

Assessed the presepsin diagnostic accuracy of presepsin in diagnosing children sepsis and in discriminating systemic inflammatory response syndrome (SIRS) from sepsis. Diagnostic accuracies presented as area under the curve (AUC) for sCD14-ST.

Preliminary reports suggest that levels of presepsin are significantly higher in septic patients than in healthy individuals. The aim of this study is to investigate the diagnostic and prognostic value of presepsin compared to other inflammatory markers in children with SIRS and suspected sepsis or septic shock. Receiver operating characteristic (ROC) curve analysis will performed for presepsin and compared to ROC curve analysis of current available infection biomarkers.

Sepsis mortality in children remains high despite advances in diagnosis and treatment. Early identification and risk stratification is a key point in the triage of patients with sepsis. The aim of the study is identifying and testing of presepsin with improved sensitivity and specifity for the presence of sepsis, and prediction of morbidity and mortality.

Jiří Žurek

M.D., Ph.D.

Brno University Hospital

Application of acoustical pulse energy (extracorporeal shockwaves) to target ulcer + standard of care

Non-energized (inactive - Sham)) application + standard of care

dermaPACE: dermaPACE + Standard of care wound dressing.

dermaPACE Application + Standard of Care

Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.

Non-energized (Inactive) Application + Standard of Care

Total

Sex: Female, Male

Region of Enrollment

dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing.

Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing.

The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.

Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application

Overall Study

Dr. Daniel Jorgensen, MD

Diabetic Foot Ulcers

Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.

acoustical pulse energy (extracorporeal shockwave)

Non-energized (inactive - Sham) application + standard of care

burns/protease

Tryptase Level as a Marker of Complications in Transcatheter Aortic Valve Replacement

Utility of Presepsin in Children Sepsis

Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers

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