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Table 1 Studies included in the systematic review

From: Tranexamic acid is associated with reduced mortality, hemorrhagic expansion, and vascular occlusive events in traumatic brain injury – meta-analysis of randomized controlled trials

Authors

Study Design

TXA Protocol

Matching Placebo

Sample Size (n)

Age (mean ± SD, years)

Male (%)

Time from Injury Eligibility (hours)

Mean Time from Injury (hours)

Funding

CRASH-32019

Double-blind RCT

1 g TXA infused over 10 min, followed by IV infusion of 1 g over 8 h

Matching Placebo (NS)

9127 (4613/4514)

41.7 ± 19.0 vs 41.9 ± 19.0

80 vs 80

Originally 8, changed to 3 h

1.9 ± 0.7

National Institute for Health Research Health Technology Assessment, JP Moulton Charitable Trust,

Department of Health and Social Care, Department for International Development, Global Challenges Research

Fund, Medical Research Council, and Wellcome Trust (Joint Global Health Trials scheme).

NCT01990768 (Bolus-Maintenance Group)

Double-blind RCT

1 g TXA bolus (prehospital), followed by IV infusion of 1 g over 8 h

Matching Placebo (NS)

621 (312/309)

39 (26–57) vs 36 (25–55)

73 vs 75

2

N/A

National Heart, Lung, and Blood Institute; United States Army Medical Research Acquisition Activity

Chakroun-Walha 2018

Open-label RCT

1 g TXA infused over 10 min, followed by IV infusion of 1 g over 8 h

None (no TXA)

180 (96/84)

44 ± 20 vs 39 ± 18

M/F Ratio: 11 vs 8.3

24

N/A

None

Fakharian 2017

Double-blind RCT

1 g TXA infused over 10 min, followed by IV infusion of 1 g over 8 h

Matching Placebo (NS)

149 (74/75)

42.3 ± 18.3 vs 39.3 ± 18.1

91 vs 88

8

N/A

Kashan University of Medical Sciences

Jokar 2017

Single-blind RCT

1 g TXA infused over 10 min, followed by IV infusion of 1 g over 8 h

Unobvious Placebo

80 (40/40)

35.4 ± 14.6 vs 36.2 ± 14.9

40 vs 35

2

N/A

Arak University of Medical Sciences

CRASH-22013

Double-blind RCT

1 g TXA infused over 10 min, followed by IV infusion of 1 g over 8 h

Matching Placebo (NS)

10,060/10067

34.6 ± 14.1 vs 34.5 ± 14.4

84 vs 84

8

2.9 ± 2.6

Health Technology Assessment Programme; National Institute for Health Research

Yutthakasemsunt 2013

Double-blind RCT

1 g TXA infused over 30 min, followed by IV infusion of 1 g over 8 h

Matching Placebo (Sterile Water)

238 (120/118)

34.8 ± 16.0 vs 34.1 ± 15.3

86 vs 91

8

7.1 ± 1.29

The Thailand Research Fund

  1. NS Normal Saline, RCT Randomized Controlled Trials, SD Standard Deviation, TXA Tranexamic Acid