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ULTRA Trial – Tranexamic Acid in SAH

Dr Swapnil Pawar April 25, 2021 192


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    ULTRA Trial – Tranexamic Acid in SAH
    Dr Swapnil Pawar

 

Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA): a randomised controlled trial

Question

Does the use of early, short-duration fibrinolytic agents improve clinical outcomes in subarachnoid hemorrhage?

Design, setting

Randomized controlled trial from 8 centres in the Netherlands

Population

Inclusion

Adult patients (age ≥18 years) with CT-confirmed subarachnoid hemorrhage

Signs and symptoms suggestive of SAH for less than 24 h

Non-contrast CT-confirmed subarachnoid hemorrhage

Exclusion

The peri-mesencephalic bleeding pattern on CT with Glasgow Coma Scale score of 13–15, without loss of consciousness soon after the event or absence of focal neurological deficit on admission

Traumatic subarachnoid hemorrhage pattern on CT

Being treated for deep vein thrombosis or pulmonary embolism

Prior procoagulant disorder

Pregnancy

Renal dysfunction with serum creatinine >150 μmol/L

Likelihood of death within 24 h

Intervention

Tranexamic acid as early as possible after the event. Administered as a bolus dose of 1 g followed by 1 g 8 h. Treatment continued until commencement of endovascular or surgical treatment or for a maximum of 24 h with a total dose of not more than 4 g tranexamic acid.

The median time of commencement 185 min (IQR 130–333)

480 patients in the TX group vs. 475 controls

Mean age was 58·4 years (SD 12·4), and 644 (67%) were female

Control

Usual care

Primary outcome

Clinical status, assessed by the modified Rankin Scare by telephonic interview at 6 months; assessors were masked to the allocation.

0 No symptoms at all

1  No significant disability despite symptoms; able to carry out all usual duties and activities

2  Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

3  Moderate disability; requiring some help, but able to walk without assistance

4  Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance

5  Severe disability; bedridden, incontinent and requiring constant nursing care and attention

6  Dead

Good outcome: 0–3

Poor outcome: 4–6

Intention to treat analysis

Result –

Per protocol, analysis was not significantly different

Adjusted analysis after adjustment for treatment centre: not different

Secondary outcomes

MRS (0–2) at 6 months

Excellent clinical outcome (MRS 0–2) was significantly lower in the tranexamic acid group than in the control group (OR 0·74, 95% CI 0·57–0·96), which remained after adjustment for treatment centre (aOR 0·73, 95% CI 0·57–0·95).  

Ordinal shift analysis (based on the difference in each category of the MRS scores) at 6 months (sensitivity analyses)

All-cause mortality at 30 days – no difference 

All-cause mortality after 6 months – no difference.

Predefined serious adverse events

   No statistically significant difference between 2 groups.

Strengths –

Pragmatic design

Multi-centre RCT with the control group

Good internal validity

Started early to prevent rebleed; stopped early to prevent possible ischemia (maximum for 24 h or until fixing the aneurysm, whichever occurred earlier)

The median interval between SAH to tx was 3 hr ; but half of all rebleeds occur within 3 h

Limitations – 

Unblinded

Early obliterative treatment may not be feasible in most communities

The role of pre-hospital administration of TXA still remains unknown.

Our recommendation – 

There is NO ROLE of TXA in the treatment of SAH and the current practice of SAH management should not be changed.

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