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Table 1 Baseline characteristics of included studies

From: The efficacy of tranexamic acid treatment with different time and doses for traumatic brain injury: a systematic review and meta-analysis

Study author and year

Study design

patients TXA/placebo

TXA dose

Male (%)

Mean or median age in years TXA/placebo

Enrollment time after trauma

Inclusion criteria

Exclusion criteria

Roberts et al. 2019

Multisite RCT

6406/6331

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 3742 (80%) placebo: 3660 (80%)

TXA: 41.7 (19) placebo: 41.9 (19)

2 h

(1) Adults with TBI within 3 h of injury

(2) GCS ≤ 12 or any intracranial bleeding on CT scan

Major extracranial bleed

Rowell et al. 2020 [13]

Multisite RCT

657/309

Bolus-Maintenance arm: 1 g TXA bolus followed by 1 g TXA. Bolus only arm: 2 g TXA bolus followed by a placebo infusion

Bolus-Maintenance: 227 (73%) Bolus-Only: 255 (74%) placebo: 233 (75%)

Bolus-Maintenance arm: 39(26–57)

Bolus Only arm: 40(26–56)

Placebo arm: 36(25–55)

2 h

(1) GCS ≤ 12

(2) Prehospital SBP ≥ 90

(3) Age ≥ 15 years (or weight ≥ 50 kg if age is unknown)

(1) GCS = 3 with unreactive pupil

(2) CPR by EMS prior to randomization

(3) Burns

(4) Pregnancy

Mahmood et al. 2021 [14]

Multisite RCT

884/883

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 701 (79%) placebo: 712 (81%)

TXA: 45 (29–64) placebo: 45 (29–63)

3 h

(1) Adults with head injury who were within 3 h of injury; (2) Glasgow Coma Score (GCS) of ≤ 12; (3) any intracranial bleeding on CT, and no significant extracranial bleeding

significant extracranial bleeding

van Wessem et al. 2021 [15]

Single site RCT

120/114

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 80 (67%) placebo: 77 (68%)

TXA: 42 (23–59) placebo: 53 (33–65)

1 h

TBI (AIS head ≥ 3) who were admitted to the adult ICU

AIS head scores based on isolated C-spine injuries

Mojallal et al. 2020 [16]

Single site RCT

56/44

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 40 (71.4%) placebo: 40 (90.9%)

N/A

8 h

(1) age > 18. (2) detection of cerebral hemorrhage in brain CT scan (3) passage of less than 8 h after trauma incidence (4) negative history of taking anticoagulants (5) negative history of blood coagulation system impairments

patients who underwent craniotomy less than 24 h

Mousavinejad et al. 2020 [17]

Single site RCT

20/20

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 6 (30%) placebo: 8 (40%)

55 ± 19/55 ± 18

8 h

(1) ≥ 18 years within 8 h of injury

(2) TBI on brain CT with no significant epidural hemorrhage

(3) The need for surgery

(1) Pregnancy

(2) Coagulopathy

(3) Massive transfusion and/or fresh frozen plasma (FFP)

Yutthakasemsunt et al. 2013 [18]

Single site RCT

120/118

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 103 (86%) placebo: 107 (91%)

35 (16)/ 34 (15)

8 h

(1) Age ≥ 16 years

(2) Moderate to severe TBI (GCS) 4 to 12

(3) Had a CT brain within 8 h

(4) No immediate indication for surgery

(1) Immediate need for surgery

(2) Coagulopathy

(3) Known to be receiving a medication that affects hemostasis

(4) Pregnancy

Fakharian et al. 2017

Single site RCT

78/78

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 67 (90.5) placebo: 6 688)

42 ± 18/39 ± 18

8 h

(1) Age ≥ 15 years

(2) Non-penetrating injury and any kind of Traumatic ICH

(3) Arrived at the hospital within 8 h

4) No need for brain surgery during the first 8 h

(1) Major organ damage

(2) Pregnancy

(3) Receiving any medication that disturbs homeostasis

(4) Coagulopathy

Jokar et al. 2017 [19]

Single site RCT

40/40

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 32 (40.0%) placebo: 28 (35.0%)

35 ± 15/ 36 ± 145

2 h

(1) TBI patients aged 15 years and more

(2) Within 2 h of injury onset

(3) Acute ICH (volume of less than 30 ml) based on CT scan findings

(1) GCS < 8

(2) Need for surgery

(3) Cerebral edema with midline shift

(4) Coagulation disorders

(5) Pregnancy

(6) History or current VTE

Ebrahimi et al. 2019 [20]

Single site RCT

40/40

1 g TXA bolus followed by 1 g TXA maintenance

SDH-TXA: 17 (85%) SDH-placebo: 17 (85%) EDH-TXA: 16 (80%) EDH-placebo: 18 (90%)

SDH: 40 ± 18/40 ± 18

EDH: 24 ± 7/25 ± 7

8 h

(1) Adults within 8 h of injury

(2) Isolated SDH or EDH requiring surgery

(1). Major extracranial bleeding

(2) Massive transfusion

(3) Coagulopathy

(4) Pregnancy

Perel et al. 2012 [21]

Multisite RCT

133/137

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 111 (84.0) placebo: 117 (85.0)

36.2 (14.0)/37.0 (13.7)

8 h

1) Fulfills the inclusion criteria for the CRASH-2 trial

(2) GCS ≤ 14

(3) Baseline clinical CT scan consistent with TBI

(1) Pregnancy and

(2) Patients for whom a second brain CT scan was not possible

Bossers et al. 2021 [22]

Multisite RCT

693/1134

1 g TXA bolus followed by 1 g TXA maintenance: 615

 > 2 g TXA bolus: 4

TXA: 486 (70%) placebo: 797 (70%)

47 (25–66)/45 (22–65)

N/A

1) severe TBI, GCS ≤ 8 2) suspected rather than confirmed TBI because prehospital treatment, including administration of tranexamic acid

1) BRAIN-PROTECT database who were not transported to a participating trauma center (no follow-up data were available) 2) undergoing prehospital traumatic cardiopulmonary resuscitation (inherently very high mortality, regardless of treatment)

Chakroun et al. 2018

Single site RCT

96/84

1 g TXA bolus followed by 1 g TXA maintenance

TXA: 88 (91.7%) placebo: 797 (70%)

44 ± 20/39 ± 18

8 h

(1) age > 18. (2) intracranial bleeding in the first or the second brain CT-scan (3) a delay of management in the study center under 24 h after trauma

1) significant extra cranial bleeding 2) TXA can improve outcome

  1. RCT Randomized-controlled trial, TXA Tranexamic acid, GCS Glasgow coma scale, GOS Glasgow outcome scale, TBI Traumatic brain injury, SDH Subdural hemorrhage, EDH Epidural hemorrhage, ICH Intracranial hemorrhage, N/A Not applicable