Trial | Year | Classification used | Fatal/life-threatening | Major | Minor |
---|---|---|---|---|---|
TIMI | 1988 | Â | Â | Intracranial or associated with an HGB decrease of greater than 5 g/dL (or 15% in hematocrit) | HGB decreasing greater than 3 g/dL (or hematocrit decreasing at least 10%) |
TIMI II | 1997 | Â | Intracranial hemorrhage, pericardial hemorrhage with tamponade, and greater than 5 g/dL drop in HGB | Blood loss greater than 3 g/dL but less than 5 g/dL or if the patient had gross hematurie, hemoptysis, or hematemesis | Â |
GUSTO | 1993 | Â | Intracerebral or if it resulted in substantial hemodynamic compromise requiring treatment | Need for transfusion | Other bleeding, not requiring transfusion or causing hemodynamic compromise |
SYNERGY | 2004 | TIMI + GUSTO | Â | Â | Â |
PARAGON-A | 1998 | Modified GUSTO | Intracranial hemorrhage or bleeding leading to hemodynamic compromise requiring intervention | Bleeding requiring transfusion, an HGB decrease of at least 5 g/dL, or a hematocrit decrease of at least 15% | Â |
PARAGON-B | 2002 | Â | Â | Â | Â |
PURSUIT | 1998 | GUSTO | Â | Â | Â |
CURE | 2004 | Â | Fatal, that led to a decrease in HGB concentration of greater than 5 g/dL, that caused significant hypotension requiring intravenous inotropes or surgical intervention, or that resulted in symptomatic intracranial hemorrhage or necessitated transfusion of at least 4 units of blood | Bleeding that required at least 2 units blood or was significantly disabling or intraocular | Â |
ACUITY | 2004 | Â | Â | Intracranial bleeding, intraocular bleeding, access-site hemorrhage requiring intervention, hematoma of at least 5 cm in diameter, reduction in HGB concentration of at least 4 g/dL without an overt source of bleeding, reduction in HGB concentration of at least 3 g/dL with an overt source of bleeding, reoperation for bleeding, use of any blood product transfusion | Â |
OASIS-5 | 2005 | Â | Â | Clinically overt bleeding that is fatal, symptomatic intracranial, retroperitoneal, or intraocular, an HGB decrease of at least 3.0 g/dL (with each blood transfusion unit counting for 1.0 g/dL of HGB), or requiring transfusion of at least 2 units of red blood cells | Â |
REPLACE-2 | 2006 | Â | Â | Any HGB drop of greater than 4 g/dL, overt bleeding with HGB drop of greater than 3 g/dL, a blood transfusion of at least 2 units or retroperitoneal, intraocular, or intracranial hemorrhage | Overt bleeding not meeting criteria for major bleeding |
OASIS-6 | 2006 | Â | Â | Fatal, intracranial, cardiac tamponade, or bleeding that was felt to be clinically significant and resulted in an HGB decrease of greater than 5 g/dL, with each transfused unit counted as a 1.0 g/dL drop in HGB | Clinically overt bleeding associated with an HGB decrease of 3.0 to 5.0 g/dL (with each transfused unit counted as a 1.0 g/dL drop in HGB) and which did not meet the criteria for severe hemorrhage |
HORIZONS-AMI | 2008 | Â | Â | Intracranial bleeding, intraocular bleeding, retroperitoneal bleeding, access-site hemorrhage requiring surgery or a radiologic or interventional procedure, hematoma of at least 5 cm in diameter at the puncture site, reduction in HGB concentration of at least 4 g/dL without an overt source of bleeding, reduction in HGB concentration of at least 3 g/dL with an overt source of bleeding, reoperation for bleeding, or use of any blood product transfusion | Â |
ACUITY | 2010 | Â | Fatal or leading to an HGB drop of at least 5 g/dL, or significant hypotension with the need for inotropes, or requiring surgery (other than vascular site repair), or symptomatic intracranial hemorrhage, or requiring transfusion of at least 4 units of red blood cells or equivalent in whole blood | Significantly disabling, intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2 or 3 units of red blood cells or equivalent in whole blood | Â |
PLATO | 2011 | Â | Fatal bleeding, intrapericardial bleeding with cardiac tamponade, intracranial bleeding, severe hypotension, hypovolemic shock due to bleeding, HGB decline of 5.0 g/dL, need for transfusion of more than 4 units | Clinical significant disability, HGB drop of 3 to 5 g/dL, requiring transfusion of 2 to 3 units of red blood cells | Any bleeding event requiring medical intervention but not meeting the criteria for major bleeding |
GRACE | 2003 | Â | Â | Life-threatening bleeding requiring transfusion of at least 2 units of packed red blood cells, or resulting in an absolute decrease in hematocrit of at least 10% or death, or hemorrhagic/subdural hematoma | Â |
RIVAL | 2011 | Â | Â | Non-CABG related major bleeding that (a) is fatal, (b) results in transfusion of at least 2 units of red blood cells or equivalent whole blood, (c) causes significant hypotension with the need for inotropes or surgical intervention (a requirement for surgical access-site repair will constitute major bleeding only if there has been significant hypotension or transfusion of at least 2 units), (d) causes significantly disabling sequellae, or (e) is intracranial and symptomatic or intraocular and leads to significant visual loss | Bleeding events that did not meet the criteria for a major bleed and required transfusion of more than one unit of blood or modification of the drug regiment |