Texas Tech School of Pharmacy
Primary Care Core Educational Topics
Definition of Major and Minor Hemorrhage
Precise estimates of hemorrhagic event rates are complicated by the inconsistency between classification schemes in clinical research studies.
The goal of classification is to place a bleeding episode on a continuum of severity ranging from minor events, such as brief epistaxis that would not have been reported to a physician (but would, for example, be recorded as part of a clinical trial), to a fatal or life-threatening episode of bleeding. Fihn et al established the following three categories:
(reported, but not requiring additional testing, referrals, or visits);
(requiring treatment, medical evaluation, or at least 2 U blood); and
(leading to cardiac arrest, surgical/angiographic intervention, or irreversible sequelae).
Most other investigators, however, divide adverse events into minor and major categories, with major events including fatal or life-threatening bleeding episodes (eg, intracranial or retroperitoneal) or bleeding with a defined drop in hemoglobin level, leading to transfusion of a specified number of units of blood or to hospitalization. The reader must be aware of these discrepancies when interpreting the results from clinical studies. For purposes of comparison between studies, we suggest that investigators define hemorrhagic events into major and minor categories with qualifying criteria such as those examples listed above.
UNITED STATES OF AMERICA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE.
That was a clinically overt bleed that caused one or more of the following: Death; transfusion of at least two units of pack cells or whole blood; a drop in hemoglobin of 30 grams per liter or more; or was retroperitoneal, intracranial or intraocular in location.
Was an overt hemorrhage that did not meet the classification for major and: was felt to be notable by the committee. Minor hemorrhages included but weren't limited to epistaxis lasting longer than five minutes or requiring intervention, ecchymosis or hematoma greater than 5 centimeters, macroscopic hematuria unassociated with urinary trauma, subconjunctival hemorrhage that caused cessation of therapy, or GI hemorrhage, again unassociated with trauma.http://www.fda.gov/ohrms/dockets/ac/97/transc...