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 2
Patient demographics and baseline disease characteristics.
Plasma ()
4F-PCC ()
Study site, (%)
SFH
13 (65)
11 (50)
URMC
7 (35)
11 (50)
Study, (%)
Acute bleeding study
17 (85)
20 (90.9)
Urgent surgery/procedure study
3 (15)
2 (9.1)
Age, years
Mean (SD; range)
75 (11; 51, 92)
73 (14; 33, 96)
Female gender, (%)
11 (55)
9 (41)
Body mass index, kg/m2
Mean (SD)
29.9 (6.5)
30.1 (13.5)
Initial (admission) Hgb, g/dL
Mean (SD)
8.6 (2.9)
8.5 (2.1)
Initial (admission) Hct, %
Mean (SD)
26.5 (8.1)
25.8 (6.2)
Initial (admission) INR
Mean (SD)
4.7 (3)
5.5 (3.3)
Time on VKA treatment prior to study entry, days
10
16
Mean (SD)
1784 (1851)
1503 (1604)
VKA dose, mg
Mean (SD)
4.9 (2)
4.1 (2.1)
Indication for VKA treatment, (%)
Atrial fibrillation
11 (55)
16 (72)
Cerebral ischemia
3 (15)
1 (4.5)
Cardiac failure congestive
1 (5)
0
Pulmonary embolism
1 (5)
2 (9.1)
Aortic valve replacement
1 (5)
1 (4.5)
Deep vein thrombosis
1 (5)
2 (9.1)
Sick sinus syndrome
1 (5)
0
Coronary artery disease
1 (5)
0
Site of GI bleed, (%)
Upper GI
3 (10)
4 (18.2)
Lower GI
3 (15)
5 (22.7)
Unspecified/data unavailable
14 (75)
13 (59.1)
Where bleeding site was given as “probably upper,” site of bleed was considered unspecified. 4F-PCC, 4-factor prothrombin complex concentrate; GI, gastrointestinal; Hct, hematocrit; Hgb, hemoglobin; INR, international normalized ratio; SD, standard deviation; SFH, Seton Family of Hospitals, Austin, Texas; VKA, vitamin K antagonist; URMC, University of Rochester Medical Center, Rochester, New York.
