TABLE 2.

Hemorrhagic and Thrombotic Complication Rate Per Day on Heparin and Per Day on Bivalirudin, in 144 Patients on Extracorporeal Membrane Oxygenation

Complications	Rate Per Day on Heparin	1 Event q x Days	Rate Per Day on Bivalirudin	1 Event q x Days	Incidence Rate Ratio (95% CI)	p
All complications	0.13	8	0.06	17	0.78 (0.29–2.1)	0.633
Hemorrhagica	0.08	13	0.03	33	0.99 (0.24–4.0)	0.991
Thromboticb	0.05	20	0.03	33	0.59 (0.14–2.4)	0.465
Complications after 48 hr on extracorporeal membrane oxygenation
	Rate Per Day on Heparin	1 Event q x Days	Rate Per Day on Bivalirudin	1 Event q x Days	p
All complications	0.10	10	0.08	13	0.200
Hemorrhagica	0.06	16	0.05	20	0.083
Thromboticb	0.04	27	0.03	33	0.140

q = every, i.e., one complication event occurred for every 8 d on heparin. ^aHemorrhagic complications include surgical or cannulation site bleeding requiring RBC transfusion or intervention, gastrointestinal bleeding, pulmonary hemorrhage, disseminated intravascular coagulation, intracerebral hemorrhage, subarachnoid hematoma, subdural hematoma, or other hemorrhage requiring transfusion or intervention.

^bThrombotic complications include limb ischemia, ischemic stroke, intracardiac thrombus, deep venous thromboembolism, pulmonary embolus, or heparin-induced thrombocytopenia.

The complication rates are also presented as one complication occurs every x days on therapy. The incidence rate ratio, calculated using Poisson regression, compares the incidence rate of the complication while on bivalirudin with the incidence rate while on heparin. Also shown is the rates of only those complications that occurred after 48 hr on extracorporeal membrane oxygenation.