FAQs

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Q?

Can I randomise a patient that has been administered warfarin?

A.

There is no absolute contraindication to randomising a warfarinised patient and we anticipate that many older patients are likely to bleed for exactly that reason. What we know is that there is no direct interaction between PCC (Factors II, VII, IX & X) and tranexamic acid. Factors II, VII, IX and X do not have lysine binding sites and this is the pathway by which tranexamic acid acts. Although PCCs have been associated with increased thrombotic risk in some settings, there is no specific contraindication to its use with tranexamic acid.

Q?

Surgery is indicated in a randomised patient, what do I do?

A.

The decision for surgery will be that of the doctor treating the patient. Inclusion of the patient in this trial will not alter that. As indicated in the Protocol and in the Investigator’s Manual of Operating Procedures, patients should receive ALL clinically indicated treatments (which may include surgery). There is no standard process for deciding when surgery is indicated and all investigators should follow their clinical judgment.

Q?

What is the standard treatment for TBI?

A.

There is a wide spectrum of treatments for Traumatic Brain Injury (TBI). The treatment given is based on the clinical judgement of the doctor with primary responsibility for the care of a particular patient. There is no need to withhold any clinically indicated treatment in this trial. The trial treatment (tranexamic acid or placebo) would be provided as an additional treatment to the usual management of TBI. Giving the trial treatment must not delay any other clinical decisions (eg the need for surgery) or giving additional medical interventions.

Q?

How will participants be randomised?

A.

Randomisation codes have been generated and secured by an independent statistical consultant. Randomisations were balanced in blocks of 8 (corresponding to a box of trial treatment packs) so that each box contains either tranexamic acid or placebo in random order. The codes will be made available to the drug packing company explicitly for the treatment packs to be created in accordance with the randomisation list.

Baseline information will be collected on the trial entry form and after eligibility has been confirmed and appropriate consent process complete, the lowest consecutively numbered pack will be taken from the box of eight treatment packs. At the point when the treatment ampoules in both dose packs are confirmed to be intact, the patient is considered to be randomised onto the trial. The completed entry form data will be sent to the Trial Coordinating Centre as soon as possible. Once randomised, the outcome of the woman should be obtained even if the trial treatment is interrupted or is not actually given.

Q?

Do hospitals taking part in the trial need to manage traumatic brain injured patients in the same way?

A.

In a large trial involving hundreds of hospitals internationally it is inevitable that there will be some differences in the management of patients between hospitals. However, these will not bias the trial results. Providing that the trial is large enough, randomisation will ensure that the intervention and control groups are identical with regard to both known and unknown confounders.

It is possible that the size of the intervention effect may vary a little bit depending on the type of management given. Nevertheless, any differences would not affect the direction of the treatment effects. Patients in the future will almost certainly receive different forms of care than they do today. Treatments shown to be effective today may be more or less effective in the future, but the direction of the effect will be the same. Rather than standardise patient management, it is more important that the trials are large enough.

Q?

Eligible patients need to have any intracranial bleeding on CT scan OR, if no scan is available, a GCS of 12 or less. Why use a GCS of 12 or less as one of the eligibility criteria?

A.

We know from the CRASH-2 trial that treatment with tranexamic acid is time critical so there should not be a great delay waiting for a CT scan. In some countries there is quite a long wait for a patient to have one or CT scanning facilities may not be available at all.

Therefore, an easy measure is needed allowing us to capture the patients with a high risk of having an intracranial bleed. A total of 7,796 patients (78%) of the 10,008 recruited in the CRASH-1 trial had a CT scan. There was evidence of intracranial bleeding (defined as the presence of evacuated haematoma, non evacuated haematoma, subarachnoid haemorrhage or petechial haemorrhages) in 49%, 64% and 80% of patients with mild, moderate and severe TBI respectively. The frequency of intracranial bleeding for patients with GCS <13 was 73%. In the CRASH-2 Intracranial Bleeding Study, 84% of patients with GCS <13 had an intracranial bleed (defined as the presence of parenchymal, subdural or epidural haemorrhage).

If a patient is randomised using the GCS and is later found not to have a bleed on CT, the treatment should simply be stopped and the data collected as per the protocol. As an intention to treat trial, these patients remain in the trial and their data will contribute to the final analysis. Recruitment of patients who subsequently have no bleed on a CT scan will contribute to this trial. This is the nature of a pragmatic trial.