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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

Spoon Feed
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?