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Table 1 Bleeding classifications used in acute coronary syndrome trials [20–23, 26–38]

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.