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ULTRA RCT – TXA for SAH?

February 18, 2021

Introducing Dr. Lisa Birdsall Fort, MD, MPH, Section Head, Department of Emergency Medicine, Ochsner Health System! Welcome to JournalFeed!


Written by Lisa Birdsall Fort

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ULTRA-early, short term IV TXA in patients with SAH with suspected aneurysm rupture did not improve clinical outcomes of patients as described by “good” (0-3) versus “poor” (4-6) modified Rankin Scale at 6 months. 

Why does this matter?
TXA is a hot topic in all things bleeding in the ED, with some studies showing benefit (1, 2 ,3,4) and some not so much (5, 6).  It’s cheap and appealing for high morbidity/mortality diseases when tertiary specialty care is necessary to control bleeding source.  The king of the non-compressible vessels is arguably located in the circle of Willis. Can TXA improve outcomes?

ULTRA-bummed
This was a prospective RCT conducted in the Netherlands with 955 patients with CT-proven SAH.   Previous concern of delayed cerebral ischemia limiting benefit of reduced rebleeding was mitigated by the shorter duration of TXA (7).  The study population matched the classic risk group: females (67%), age mid-50s (mean 58.4 years).  Patients were randomized to TXA + usual care (n=480) vs usual care only (n=475).  Initial CT was a median of 93 minutes from nidus.  They used TXA 1g bolus then continuous infusion 1g/8 hours with termination immediately prior to intervention (median 14 hours) or at 24 hours, whichever came first.  Limitations included: treatment team was not blinded, and in 14% TXA/15% control there was no causative aneurysm found. Rebleeding occurred in 49 (10%) of TXA patients and 66 (14%) usual care patients (OR 0.71, 95% CI 0.48-1.04).  The primary outcome was assessed in 945/955 by nurses blinded to study group via phone interview at 6 months, who assigned a modified Rankin Scale with 0-3 “good” and 4-6 “poor.”  Of these, 287 (60%) patients in the TXA group and 300 (64%) patients in the control group had a good clinical outcome.  I’m ULTRA disappointed this one didn’t work.

Source
Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA): a randomised controlled trial. Lancet. 2021 Jan 9;397(10269):112-118. doi: 10.1016/S0140-6736(20)32518-6. Epub 2020 Dec 23.

Works Cited

  1. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial.  Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

  2. Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial. Lancet. October 14 2019.

  3. Effect of tranexamic acid on mortality in patients with haemoptysis: a nationwide study. Crit Care. 2019 Nov 6;23(1):347. doi: 10.1186/s13054-019-2620-5.

  4. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial.  Lancet. 2017 Apr 26. pii: S0140-6736(17)30638-4. doi: 10.1016/S0140-6736(17)30638-4. [Epub ahead of print]

  5. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.  Lancet. 2020 Jun 20;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

  6. Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Pati.     ents With Moderate or Severe Traumatic Brain Injury. JAMA. 2020 Sep 8;324(10):961-974. doi: 10.1001/jama.2020.8958.

  7. Hillman J, Fridriksson S, Nilsson O, Yu Z, Saveland H, Jakobsson KE. Immediate administration of tranexamic acid and reduced incidence of early rebleeding after aneurysmal subarachnoid hemorrhage: a prospective randomized study. J Neurosurg 2002; 97: 771–78.

What are your thoughts?