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Table 1 Bleeding classifications used in acute coronary syndrome trials [2023, 2638]

From: Clinical review: Bleeding - a notable complication of treatment in patients with acute coronary syndromes: incidence, predictors, classification, impact on prognosis, and management

Trial Year Classification used Fatal/life-threatening Major Minor
TIMI 1988    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   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  
GUSTO 1993   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    
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%  
PARAGON-B 2002     
PURSUIT 1998 GUSTO    
CURE 2004   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  
ACUITY 2004    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  
OASIS-5 2005    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  
REPLACE-2 2006    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    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    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  
ACUITY 2010   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  
PLATO 2011   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    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  
RIVAL 2011    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
  1. ACUITY, Acute Catheterization and Urgent Intervention Triage Strategy; CABG, coronary artery bypass graft; CURE, Clopidogrel in Unstable Angina to Prevent Recurrent Events; GRACE, Global Registry of Acute Coronary Events; GUSTO, Global Use of Strategies to Open Occluded Arteries; HGB, hemoglobin; HORIZONS-AMI, Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction; OASIS, Organization to Assess Strategies for Ischemic Syndrome; PARAGON, Platelet IIb/IIIa Antagonism for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network; PLATO, Platelet Inhibition and Patient Outcomes; PURSUIT, Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy; REPLACE, Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events II; RIVAL, Radial vs Femoral Access for Coronary Intervention; SYNERGY, Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors; TIMI, Thrombolysis In Myocardial Infarction.