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Time Course of Early Hematoma Expansion in Acute Spot-Sign Positive Intracerebral Hemorrhage: Prespecified Analysis of the SPOTLIGHT Randomized Clinical Trial

2023; Lippincott Williams & Wilkins; Volume: 54; Issue: 3 Linguagem: Inglês

10.1161/strokeaha.121.038475

1524-4628

Fahad Al-Ajlan, David J. Gladstone, Dongbeom Song, Kevin E. Thorpe, Rick Swartz, Kenneth Butcher, Martín del Campo, Dar Dowlatshahi, Henrik Gensicke, Gloria Jooyoung Lee, Matthew L. Flaherty, Michael D. Hill, Richard I. Aviv, Andrew M. Demchuk, Richard H. Swartz, David J. Gladstone, Karl Boyle, Maria Braganza, Nadia Fedasko, D Golob, Edith Bardi, Samantha Senyshyn, Megan L. Cayley, Connie Colavecchia, Andrew M. Demchuk, Michael D. Hill, Shelagh B. Coutts, Gary Klein, Bijoy K. Menon, Tim Watson, Eric E. Smith, Suresh Subramaniam, Simerpreet Bal, Philip A. Barber, Marie‐Christine Camden, Myles Horton, Sachin Mishra, Vivek Nambiar, Andres Venegas Torres, Sweta Adatia, A Alseraya, Jamsheed A. Desai, Jennifer Mandzia, Michel Shamy, Anurag Trivedi, Philip Choi, Véronique Dubuc, Evgenia Klourfeld, Thalia S. Field, Dilip Singh, Tapuwa Musuka, Sarah Bloujney, Davar Nikneshan, Oje Imoukhuede, Amy Yu, Ramana Appireddy, J. Grimley Evans, Karla J. Ryckborst, Carly Calvert, Dar Dowlatshahi, Grant Stotts, Mukul Sharma, Sohail Robert, Melodie Mortensen, Rany Shamloul, Martín del Campo, Frank L. Silver, Leanne K. Casaubon, Cheryl Jaigobin, Yaël Perez, Libby Kalman, Jemini Abraham, R Wiegner, Anne Cayley, Victoria Riediger, Kenneth Butcher, Mahesh Kate, Thomas Jeerakathil, Ashfaq Shuaib, Sylvia Gaucher, Leka Sivakumar, Samuel Yip, Philip Teal, Andrew R. Woolfenden, Oscar Benavente, Jeff Beckman, Colleen Murphy, Thalia S. Field, Negar Asdaghi, Karina Villaluna-MurrVay, Demetrios J. Sahlas, Almunder Algird, Jordan Knapman, S. Macmillan, Janice Sancan, Manu Mehdiratta, Yaël Perez, Verity John, AlNoor Dhanani, Bryan Temple, André G. Douen, Daniel Selchen, Gustavo Saposnik, Pawel Kostyrko, Richard Chan, Bryan D. Young, Balagopal Kumar, Peter Sörös, K Hesser, Mary Wright, C. Frank, Belinda Amato-Marziali, Yan Deschaintre, Alexandre Y. Poppe, Marlène Lapierre, Jean-Martin Boulanger, Léo Berger, Lise Blais, Christel Simard, Jeanne Teitelbaum, Natasha Campbell, Al Jin, Adriana Breen, Suzanne Bickford,

Acute Ischemic Stroke Management

In the SPOTLIGHT trial (Spot Sign Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy), patients with a computed tomography (CT) angiography spot-sign positive acute intracerebral hemorrhage were randomized to rFVIIa (recombinant activated factor VIIa; 80 μg/kg) or placebo within 6 hours of onset, aiming to limit hematoma expansion. Administration of rFVIIa did not significantly reduce hematoma expansion. In this prespecified analysis, we aimed to investigate the impact of delays from baseline imaging to study drug administration on hematoma expansion.Hematoma volumes were measured on the baseline CT, early post-dose CT, and 24 hours CT scans. Total hematoma volume (intracerebral hemorrhage+intraventricular hemorrhage) change between the 3 scans was calculated as an estimate of how much hematoma expansion occurred before and after studying drug administration.Of the 50 patients included in the trial, 44 had an early post-dose CT scan. Median time (interquartile range) from onset to baseline CT was 1.4 hours (1.2-2.6). Median time from baseline CT to study drug was 62.5 (55-80) minutes, and from study drug to early post-dose CT was 19 (14.5-30) minutes. Median (interquartile range) total hematoma volume increased from baseline CT to early post-dose CT by 10.0 mL (-0.7 to 18.5) in the rFVIIa arm and 5.4 mL (1.8-8.3) in the placebo arm (P=0.96). Median volume change between the early post-dose CT and follow-up scan was 0.6 mL (-2.6 to 8.3) in the rFVIIa arm and 0.7 mL (-1.6 to 2.1) in the placebo arm (P=0.98). Total hematoma volume decreased between the early post-dose CT and 24-hour scan in 44.2% of cases (rFVIIa 38.9% and placebo 48%). The adjusted hematoma growth in volume immediately post dose for FVIIa was 0.998 times that of placebo ([95% CI, 0.71-1.43]; P=0.99). The hourly growth in FFVIIa was 0.998 times that for placebo ([95% CI, 0.994-1.003]; P=0.50; Table 3).In the SPOTLIGHT trial, the adjusted hematoma volume growth was not associated with Factor VIIa treatment. Most hematoma expansion occurred between the baseline CT and the early post-dose CT, limiting any potential treatment effect of hemostatic therapy. Future hemostatic trials must treat intracerebral hemorrhage patients earlier from onset, with minimal delay between baseline CT and drug administration.URL: https://www.gov; Unique identifier: NCT01359202.