Four-Factor Prothrombin Complex Concentrate Reduces Time to Procedure in Vitamin K Antagonist-Treated Patients Experiencing Gastrointestinal Bleeding: A Post Hoc Analysis of Two Randomized Controlled Trials

Table 5

Analyses of benefits associated with early intervention in patients with GI bleeding.

Study	Study design	Outcome with early intervention
		Cost benefit/improved health resource utilization	Reduced hospital LOS	Improved clinical outcomes
Lee et al., 1999 [20]	(i) Prospective RCT	Yes	Yes	No
	(ii) Patients admitted with nonvariceal upper GI bleeding were randomized to either
	(a) control group (elective endoscopy within 1-2 days; )
	(b) early endoscopy group (endoscopy within 1-2 h; )
Bjorkman et al., 2004 [21]	(i) Prospective, randomized, blinded, multicenter trial	No	No	No
	(ii) Patients with nonvariceal upper GI bleeding were randomized; to either
	(a) elective endoscopy (within 48 h of initial evaluation; )
	(b) urgent endoscopy (within 6 h of initial evaluation; )
Lim et al., 2011 [22]	(i) Prospective single-center trial enrolled 934 patients with nonvariceal upper GI bleeding	N/A	N/A	Yes (reduced mortality in high-risk patients)
	(ii) Lone independent risk factor associated with all-cause mortality in high risk patients (GBS ≥ 12) was found to be the time lapse between presentation and endoscopy
	(iii) This association was not replicated in low-risk patients (GBS < 12)

GBS, Glasgow-Blatchford Score; GI, gastrointestinal; h, hours; LOS,length of stay; N/A, not applicable; RCT, randomized controlled trial.