Hypoxia

Hypothermia, Accidental

Hypercapnia

Avalanche, Landslide, or Mudslide

venous blood sampling for oxygen affinity in-vitro test

blood sampling

General and Surgical Critical Care Medicine, Medical University of Innsbruck

Triple H ODC Trial

Determination of the Oxygen Dissociation Curve Under the Conditions of an Avalanche Burial With an Air Pocket

amount of p50 in mmHg (p50 = pO2 when oxygen saturation of hemoglobin is 50%)

Medical University Innsbruck

Institute of Mountain Emergency Medicine

16 combinations of 4 levels of pCO2 and 4 levels of temperature will be assessed for each participant

Anemia, Sickle Cell

Transfusion

Transfusion Treatment in Patients With SCD

National Transfusion Treatment Survey in Patients With Sickle Cell Disease (SCD)

The Survey Data Sheet is divided into three parts:
Personal data
Therapy:
Chronic transfusion regimen
Acute transfusion regimen
Hydroxyurea
Complications: -
Alloimmunization
Transfusion reactions
Martial structure and iron-chelating therapy

Società Italiana Talassemie ed Emoglobinopatie

Associazione Italiana de Ematologia e Oncologia Pediatrica

Società Italiana di Medicina Trasfusionale e Immunoematologia

Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).

Ambrisentan

Sex: Female, Male

Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)

Change from Baseline to Week 24 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.

Change From Baseline to Week 24 in Borg Dyspnea Index

Change from Baseline to Week 48 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.

Change From Baseline to Week 48 in Borg Dyspnea Index

Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP)

Percent Change From Baseline to Week 48 in BNP

Change from baseline in World Health Organization functional class (WHO) at Week 24 is the incidence of participants that improved, had no change, or worsened. WHO categories are 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.

Change From Baseline to Week 24 in WHO Functional Class

Change from baseline in WHO at Week 48 is expressed as the incidence of participants that improved, had no change or worsened. WHO categories range from 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.

Change From Baseline to Week 48 in WHO Functional Class

Change from baseline to Week 24 in the SF-36 health survey physical functioning scale. 10 activities rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.

Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale

Change from baseline to Week 48 in the SF-36 health survey physical functioning scale. 10 activities are rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General US population mean and standard deviation. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and standard deviation of 10.

Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale

Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents

Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24

Percent of Participants With no Clinical Worsening of PH at Week 48

Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents

Failure-free Treatment Status

Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment

Monotherapy Treatment Status

Defined as not dying during study participation

Long-term Survival

Overall Study

Martine Allard, PhD; Senior Clinical Research Scientist

Pulmonary Hypertension

University of Alabama at Birmingham

Arizona Pulmonary Specialists, Ltd

UCSD Medical Center, Thornton Hospital

Greater Los Angeles, VA Medical Center

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

University of Colorado Health Sciences Center

University of Connecticut Health Center

Pulmonary Hypertension Clinic Mount Sinai Medical Center

Suncoast Lung Center

Medical College of Georgia

Atlanta Institute for Medical Research, Inc.

University of Chicago Hospitals

University of Iowa Hospitals and Clinics

Johns Hopkins University

Tufts-New England Medical Center

Massachusetts General Hospital

Boston Adult Congenital Heart Service

Boston University School of Medicine

Mayo Clinic

Washington University School of Medicine

University of Medicine & Dentistry of New Jersey

Newark Beth Israel Medical Center

New York Presbyterian Pulmonary Hypertension Center

Mary Parkes Asthma Center

Duke University Medical Center

The Lindner Clinical Trial Center

University Hospitals of Cleveland

Legacy Clinical Northwest

Allegheny General Hospital

University of Pittsburgh Medical Center Presbyterian

Rhode Island Hospital

Lexington Pulmonary and Critical Care

Baylor College of Medicine

University of Virginia Health Sciences Center

St. Vincent's Hospital

Royal Perth Hospital

Peter Lougheed Centre

University of Alberta Hospitals

Toronto General Hospital

Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

ARIES-3: A Phase 3, Long-Term, Open-Label, Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

Gilead Sciences