Time Course of Early Hematoma Expansion in Acute Spot-Sign Positive Intracerebral Hemorrhage: Prespecified Analysis of the SPOTLIGHT Randomized Clinical Trial. Issue 3 (9th February 2023)

• Record Type: Journal Article
• Authors: Al-Ajlan, Fahad S.; Gladstone, David J.; Song, Dongbeom; Thorpe, Kevin E.; Swartz, Rick H.; Butcher, Kenneth S.; del Campo, Martin; Dowlatshahi, Dar; Gensicke, Henrik; Lee, Gloria Jooyoung; Flaherty, Matthew L.; Hill, Michael D.; Aviv, Richard I.; Demchuk, Andrew M.
• Other Names: Swartz Richard H. author non-byline.; Gladstone David J. author non-byline.; Boyle Karl author non-byline.; Braganza Maria author non-byline.; Fedasko Nadia author non-byline.; Golob Dolores author non-byline.; Bardi Edith author non-byline.; Senyshyn Samantha author non-byline.; Cayley Megan author non-byline.; Colavecchia Connie author non-byline.; Demchuk Andrew M. author non-byline.; Hill Michael D. author non-byline.; Coutts Shelagh author non-byline.; Klein Gary author non-byline.; Menon Bijoy author non-byline.; Watson Tim author non-byline.; Smith Eric author non-byline.; Subramaniam Suresh author non-byline.; Bal Simerpreet author non-byline.; Barber Philip author non-byline.; Camden Marie-Christine author non-byline.; Horton Myles author non-byline.; Mishra Sachin author non-byline.; Nambiar Vivek author non-byline.; Torres Andres Venegas author non-byline.; Adatia Sweta author non-byline.; Alseraya Amjad author non-byline.; Desai Jamsheed author non-byline.; Mandzia Jennifer author non-byline.; Shamy Michel author non-byline.; Trivedi Anurag author non-byline.; Choi Philip author non-byline.; Dubuc Veronique author non-byline.; Klourfeld Evgenia author non-byline.; Field Thalia author non-byline.; Singh Dilip author non-byline.; Musuka Tapuwa author non-byline.; Bloujney Sarah author non-byline.; Nikneshan Davar author non-byline.; Imoukhuede Oje author non-byline.; Yu Amy author non-byline.; Appireddy Ramana author non-byline.; Evans Jamie author non-byline.; Ryckborst Karla author non-byline.; Calvert Carly author non-byline.; Dowlatshahi Dariush author non-byline.; Stotts Grant author non-byline.; Sharma Mukul author non-byline.; Robert Sohail author non-byline.; Mortensen Melodie author non-byline.; Shamloul Rany author non-byline.; Campo Martin Del author non-byline.; Silver Frank L. author non-byline.; Casaubon Leanne author non-byline.; Jaigobin Cheryl author non-byline.; Perez Yael author non-byline.; Kalman Libby author non-byline.; Abraham Jemini author non-byline.; Wiegner Relu author non-byline.; Cayley Anne author non-byline.; Riediger Victoria author non-byline.; Butcher Ken author non-byline.; Kate Mahesh author non-byline.; Jeerakathil Thomas author non-byline.; Shuaib Ashfaq author non-byline.; Gaucher Sylvia author non-byline.; Sivakumar Leka author non-byline.; Yip Samuel author non-byline.; Teal Philip author non-byline.; Woolfenden Andrew author non-byline.; Benavente Oscar author non-byline.; Beckman Jeff author non-byline.; Murphy Colleen author non-byline.; Field Thalia author non-byline.; Asdaghi Negar author non-byline.; Villaluna-MurrVay Karina author non-byline.; Sahlas Demetrios J. author non-byline.; Algird Almunder author non-byline.; Knapman Jordan author non-byline.; Macmillan Sue author non-byline.; Sancan Janice author non-byline.; Mehdiratta Manu author non-byline.; Perez Yael author non-byline.; John Verity author non-byline.; Dhanani AlNoor author non-byline.; Temple Bryan author non-byline.; Douen Andre author non-byline.; Selchen Daniel author non-byline.; Saposnik Gustavo author non-byline.; Kostyrko Pawel author non-byline.; Chan Richard author non-byline.; Young Bryan author non-byline.; Kumar Balagopal author non-byline.; Soros Peter author non-byline.; Hesser Kimberley author non-byline.; Wright Mary author non-byline.; Frank Connie author non-byline.; Amato-Marziali Belinda author non-byline.; Deschaintre Yan author non-byline.; Poppe Alexandre author non-byline.; Lapierre Marlene author non-byline.; Boulanger Jean-Martin author non-byline.; Berger Leo author non-byline.; Blais Lise author non-byline.; Simard Christel author non-byline.; Teitelbaum Jeanne author non-byline.; Campbell Natasha author non-byline.; Jin Al author non-byline.; Breen Adriana author non-byline.; Bickford Suzanne author non-byline.;
• Is Part Of: Stroke. Volume 54:Issue 3(2023)
• Page Start: 715
• Page End: 721
• Publication Date: 2023-02-09
• Subjects: activated factor VII -- hematoma expansion -- intracerebral hemorrhage -- rFVIIa -- stroke -- tranexamic acid; Cerebrovascular disease -- Periodicals; Cerebral circulation -- Periodicals; 616.81
• DOI: 10.1161/STROKEAHA.121.038475
• Languages: English
• ISSNs: 0039-2499

Abstract

Abstract : Background: 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. Methods: 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. Results: 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). Conclusions: 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. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01359202.