TABLE 8

Safety outcomes

OutcomeStandard care arm (N = 805)Intervention arm (N = 799)Overall (n = 1604)p-value
Thrombotic events, n8585170
 Venous thromboembolism5958117
 Pulmonary embolus363874
 Deep-vein thrombosis232043
 Participants affected, n/N (%)57/805 (7.1)55/799 (6.9)112/1604 (7.0)
Arterial thrombotic events262753
 Myocardial infarction448
 Stroke111122
 Other occlusion of any other artery111223
 Participants affected, n/N (%)26/805 (3.2)26/799 (3.3)52/1604 (3.2)
Cumulative incidence of thrombotic events at day 28, % (95% CI)a12.9 (10.2 to 15.8)12.7 (10.1 to 15.6)12.8 (10.9 to 14.8)0.8852
Serious transfusion-related adverse events, n/N (%)b0/805 (0)3/799 (0.4)3/1604 (0.2)0.1234
a

p-value from Fine and Gray model.

b

p-value for Fisher’s exact test.

From: Chapter 3, Results

Cover of Early high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis
Early high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis.
Health Technology Assessment, No. 28.76.
Curry N, Davenport R, Thomas H, et al.
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