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Tranexamic acid for patients with traumatic brain injury: a randomized, double-blinded, placebo-controlled trial.

Yutthakasemsunt S, Kittiwatanagul W, Piyavechvirat P, Thinkamrop B, Phuenpathom N, Lumbiganon P - BMC Emerg Med (2013)

Bottom Line: The difference was not statistically significant [RR = 0.65 (95% CI 0.40 to 1.05)].There were no significant difference in the risk of death from all causes in patients allocated to TXA compared with placebo [RR = 0.69 (95% CI 0.35 to 1.39)] and the risk of unfavourable outcome on the Glasgow Outcome Scale [RR = 0.76 (95% CI 0.46 to 1.27)].There was no evidence of increased risk of thromboembolic events in those patients allocated to TXA.

View Article: PubMed Central - HTML - PubMed

Affiliation: Surgical Unit, Khon Kaen hospital, Khon Kaen, Thailand. surakrant@gmail.com.

ABSTRACT

Background: Traumatic brain injury (TBI) is commonly accompanied by intracranial bleeding which can worsen after hospital admission. Tranexamic acid (TXA) has been shown to reduce bleeding in elective surgery and there is evidence that short courses of TXA can reduce rebleeding in spontaneous intracranial haemorrhage. We aimed to determine the effectiveness and safety of TXA in preventing progressive intracranial haemorrhage in TBI.

Methods: This is a double blinded, placebo controlled randomized trial. We enrolled 238 patients older than 16 years with moderate to severe TBI (post-resuscitation Glasgow Coma Scale (GCS) 4 to 12) who had a computerized tomography (CT) brain scan within eight hours of injury and in whom there was no immediate indication for surgery. We excluded patients if they had a coagulopathy or a serum creatinine over than 2.0 milligrams%. The treatment was a single dose of 2 grams of TXA in addition to other standard treatments. The primary outcome was progressive intracranial haemorrhage (PIH) which was defined as an intracranial haemorrhage seen on the second CT scan that was not seen on the first CT scan, or an intracranial haemorrhage seen on the first scan that had expanded by 25% or more on any dimension (height, length, or width) on the second scan.

Results: Progressive intracranial haemorrhage was present in 21 (18%) of 120 patients allocated to TXA and in 32 (27%) of 118 patients allocated to placebo. The difference was not statistically significant [RR = 0.65 (95% CI 0.40 to 1.05)]. There were no significant difference in the risk of death from all causes in patients allocated to TXA compared with placebo [RR = 0.69 (95% CI 0.35 to 1.39)] and the risk of unfavourable outcome on the Glasgow Outcome Scale [RR = 0.76 (95% CI 0.46 to 1.27)]. There was no evidence of increased risk of thromboembolic events in those patients allocated to TXA.

Conclusions: TXA may reduce PIH in patients with TBI; however, the difference was not statistically significant in this trial. Large clinical trials are needed to confirm and to assess the effect of TXA on death or disability after TBI.

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Related in: MedlinePlus

Participant flow.
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Figure 1: Participant flow.

Mentions: Figure 1 shows the participant flow into the trial. The first patient was recruited on the 23rd October 2008 and the last patient on 14th August 2009 by which time a total of 238 patients had been included in the trial. All patients received the allocated trial treatments (TXA or placebo) and there were no protocol violations. There were nine patients for whom a second CT scan could not be obtained: seven patients died before the second CT scan, one patient could not be scanned because of agitation, and one patient refused the second scan. There were two consents withdrawal in the placebo group after randomization because they were signed by the unauthorized relatives. The related ethic committees were informed with an agreement for this exclusion. The inter-rater reliability of the assessment of the presence or absence of PIH was high with a kappa statistic of 0.95. The patients were enrolled with comparable profile including about mean age (40 years), male gender (80%), injury onset (within 7 hours), associated organ injury with injury severity score 24 (range from 9–43) and initial haematocrit level (38 volumes%) with moderately severe GCS severity. There were similar pressures effects finding of the first CT scan in both groups. Treatment and control groups were approximately balanced with respect to baseline characteristics (Table 1).


Tranexamic acid for patients with traumatic brain injury: a randomized, double-blinded, placebo-controlled trial.

Yutthakasemsunt S, Kittiwatanagul W, Piyavechvirat P, Thinkamrop B, Phuenpathom N, Lumbiganon P - BMC Emerg Med (2013)

Participant flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4221638&req=5

Figure 1: Participant flow.
Mentions: Figure 1 shows the participant flow into the trial. The first patient was recruited on the 23rd October 2008 and the last patient on 14th August 2009 by which time a total of 238 patients had been included in the trial. All patients received the allocated trial treatments (TXA or placebo) and there were no protocol violations. There were nine patients for whom a second CT scan could not be obtained: seven patients died before the second CT scan, one patient could not be scanned because of agitation, and one patient refused the second scan. There were two consents withdrawal in the placebo group after randomization because they were signed by the unauthorized relatives. The related ethic committees were informed with an agreement for this exclusion. The inter-rater reliability of the assessment of the presence or absence of PIH was high with a kappa statistic of 0.95. The patients were enrolled with comparable profile including about mean age (40 years), male gender (80%), injury onset (within 7 hours), associated organ injury with injury severity score 24 (range from 9–43) and initial haematocrit level (38 volumes%) with moderately severe GCS severity. There were similar pressures effects finding of the first CT scan in both groups. Treatment and control groups were approximately balanced with respect to baseline characteristics (Table 1).

Bottom Line: The difference was not statistically significant [RR = 0.65 (95% CI 0.40 to 1.05)].There were no significant difference in the risk of death from all causes in patients allocated to TXA compared with placebo [RR = 0.69 (95% CI 0.35 to 1.39)] and the risk of unfavourable outcome on the Glasgow Outcome Scale [RR = 0.76 (95% CI 0.46 to 1.27)].There was no evidence of increased risk of thromboembolic events in those patients allocated to TXA.

View Article: PubMed Central - HTML - PubMed

Affiliation: Surgical Unit, Khon Kaen hospital, Khon Kaen, Thailand. surakrant@gmail.com.

ABSTRACT

Background: Traumatic brain injury (TBI) is commonly accompanied by intracranial bleeding which can worsen after hospital admission. Tranexamic acid (TXA) has been shown to reduce bleeding in elective surgery and there is evidence that short courses of TXA can reduce rebleeding in spontaneous intracranial haemorrhage. We aimed to determine the effectiveness and safety of TXA in preventing progressive intracranial haemorrhage in TBI.

Methods: This is a double blinded, placebo controlled randomized trial. We enrolled 238 patients older than 16 years with moderate to severe TBI (post-resuscitation Glasgow Coma Scale (GCS) 4 to 12) who had a computerized tomography (CT) brain scan within eight hours of injury and in whom there was no immediate indication for surgery. We excluded patients if they had a coagulopathy or a serum creatinine over than 2.0 milligrams%. The treatment was a single dose of 2 grams of TXA in addition to other standard treatments. The primary outcome was progressive intracranial haemorrhage (PIH) which was defined as an intracranial haemorrhage seen on the second CT scan that was not seen on the first CT scan, or an intracranial haemorrhage seen on the first scan that had expanded by 25% or more on any dimension (height, length, or width) on the second scan.

Results: Progressive intracranial haemorrhage was present in 21 (18%) of 120 patients allocated to TXA and in 32 (27%) of 118 patients allocated to placebo. The difference was not statistically significant [RR = 0.65 (95% CI 0.40 to 1.05)]. There were no significant difference in the risk of death from all causes in patients allocated to TXA compared with placebo [RR = 0.69 (95% CI 0.35 to 1.39)] and the risk of unfavourable outcome on the Glasgow Outcome Scale [RR = 0.76 (95% CI 0.46 to 1.27)]. There was no evidence of increased risk of thromboembolic events in those patients allocated to TXA.

Conclusions: TXA may reduce PIH in patients with TBI; however, the difference was not statistically significant in this trial. Large clinical trials are needed to confirm and to assess the effect of TXA on death or disability after TBI.

Show MeSH
Related in: MedlinePlus