Academic onefile – document – tranexamic acid for patients with traumatic brain injury a randomized, double-blinded, placebo-controlled trial hipoxia anoxia

All 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 performed within eight hours of injury, and whom

There was no immediate indication for surgery, were eligible for inclusion.

There were both of isolated TBI and polytrauma patients whom there were

Critical concern for TBI management during the admission period. Patients

Were excluded if they were pregnant, had evidences of coagulopathy, known to

Be receiving a medication which affects haemostasis, or had a serum

Creatinine over than 2 mg/decilitre.


Coagulopathy was considered present if

Any of the following hematological parameters were observed: (1) platelet

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Count less than 100,000 cells/mm3; (2) prothrombin time (PT) or international

Normalized ratio (INR) prolonged more than 1.5 times normal value; (3)

Activated partial thromboplastin time (aptt) more than 10 seconds greater

Than normal value. Coagulopathy was a risk factor for developing PIH and

Mortality in previous studies [10, 11, 18]-[22] or recent reports [23, 24].

Hence it was confounding factor to be controlled by exclusion.

The randomisation sequence (with a randomly varied block size) was generated

From a computer by a person who was not involved with the trial and this

Sequence was used to prepare the sequentially numbered treatment packs.

Whenever an eligible patient was recruited, the recruiting clinician asked

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That the next sequentially numbered sealed opaque treatment pack be opened

And that the trial loading dose and maintenance infusion be prepared and sent

To the relevant ward. This preparation was done out of sight of the

Recruiting clinician and research participants by nurses who were not

Involved in the trial. Each treatment pack contained unlabelled vials of

Either drug or placebo. Although drug and placebo vials contained an

Identical amount of colorless solution, there was a small size discrepancy

Between the drug and placebo vials. It was for this reason that the vials

Were enclosed within sequentially numbered sealed opaque envelopes that were

Opened by nurses who were not involved in the trial.Hipoxia anoxia this approach ensured

Good allocation concealment and also ensured that those caring for the

Patient and those conducting the trial did not know the assigned treatment.

The allocation scheme was kept confidential from all research participants

Until the end of the study.

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,

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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.Hipoxia anoxia 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).

Table 2 shows the effect of TXA on the study outcomes by the intention to

Treat analysis with assuming poor outcome which is used to represent the

Effectiveness of treatment effect. Progressive intracranial haemorrhage was

Present in 21 (18%) of patients allocated to TXA and in 32 (27%) of patients

Allocated to placebo. The difference was not statistically significant [RR =

0.65 (95% CI 0.40 to 1.05)]. The relative risk of death from all causes in

Patients allocated to TXA compared with placebo was 0.69 (95% CI 0.35 to

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1.39) and the relative risk for unfavourable outcome on the glasgow outcome

Scale was 0.76 (95% CI 0.46 to 1.27). The relative risk of blood transfusion

Need in patients allocated to TXA compared with placebo was 0.92 (95% CI 0.61

To 1.40). Although we had informed the clinical condition and proposed for

Emergency neurosurgical operation in all patients with PIH to their

Relatives. The neurosurgical interventions were not done in placebo group

Because the patients’ relatives did not allow us to perform the

Operation hence the relative risk for neurosurgical interventions could not

Be calculated. There were very few adverse effects in both groups. There was

No patient in TXA group who developed vascular occlusion event in this study.Hipoxia anoxia