Assigned color | Recommended data collection |
---|---|
Red (essential for all studies) | Clinical bleeding events   Date/time of diagnosis   Location - gastrointestinal, genitourinary, intracranial, vascular access site, other   Related to a procedure, yes/no |
 | Laboratory parameters (dates and times of values should be recorded)   Most recent hemoglobin value before bleed is recognized   Lowest hemoglobin value within 24 hours after onset of bleeding has been recognized   Change in hemoglobin associated with clinical bleeding event |
 | Consequences of bleeding   Death related to bleeding (yes/no)   Blood transfusion--type, number of units, associated with overt bleeding (yes/no), hemoglobin value at the time of transfusion, dates and times of administration   Resulted in permanent disability (yes/no) |
Orange (recommended for all studies) | Bleeding resulted in discontinuation of therapy (yes/no) |
 | Bleeding prompted dose alteration of therapy (yes/no) |
Green (optional for all studies) | Bleeding resulted in hemodynamic compromise (yes/no) |
 | Bleeding resulted in transient disability (yes/no) |
 | Bleeding resulted in increased length of stay (yes/no)   Number of hospital days added   Number of intensive care unit days added |
 | Hemoglobin decrease associated with procedures |