The Effect of Age on Characteristics and Mortality of Intracerebral Hemorrhage in the Oldest-Old

2016 ◽  
Vol 42 (5-6) ◽  
pp. 485-492 ◽  
Author(s):  
Paola Forti ◽  
Fabiola Maioli ◽  
Michele Domenico Spampinato ◽  
Carlotta Barbara ◽  
Valeria Nativio ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Intracerebral Hemorrhage ◽  
Ct Scan ◽  
Symptom Onset ◽  
Oldest Old ◽  
Hematoma Expansion ◽  
Elderly Subjects ◽  
Supporting Evidence ◽  
Hematoma Volume ◽  
Young Old

Background: Incidence of acute intracerebral hemorrhage (ICH) increases with age, but there is a lack of information about ICH characteristics in the oldest-old (age ≥85 years). In particular, there is a need for information about hematoma volume, which is included in most clinical scales for prediction of mortality in ICH patients. Many of these scales also assume that, independent of ICH characteristics, the oldest-old have a higher mortality than younger elderly patients (age 65-74 years). However, supporting evidence from cohort studies is limited. We investigated ICH characteristics of oldest-old subjects compared to young (<65 years), young-old (65-74 years) and old-old (75-84 years) subjects. We also investigated whether age is an independent mortality predictor in elderly (age ≥65 years) subjects with acute ICH. Methods: We retrospectively collected clinical and neuroimaging data of 383 subjects (age 34-104 years) with acute supratentorial primary ICH who were admitted to an Italian Stroke Unit (SU) between October 2007 and December 2014. Measured ICH characteristics included hematoma location, volume and intraventricular extension of hemorrhage on admission CT scan; admission Glasgow Coma Scale ≤8 and hematoma expansion (HE) measured on follow-up CT-scans obtained after 24 h. General linear models and logistic models were used to investigate the association of age with ICH characteristics. These models were adjusted for pre-admission characteristics, hematoma location and time from symptom onset to admission CT scan. Limited to elderly subjects, Cox models were used to investigate the association of age with in-SU and 1-year mortality: the model for in-SU mortality adjusted for pre-admission and ICH admission characteristics and the model for 1-year mortality additionally adjusted for functional status and disposition at SU discharge. Results: Independent of pre-admission characteristics, hematoma location and time from symptom onset to admission CT-scan, oldest-old subjects had the highest admission hematoma volume (p < 0.01). Age was unrelated to all other ICH characteristics including HE. In elderly patients, multivariable adjusted risk of in-SU and 1-year mortality did not vary across age categories. Conclusions: Oldest-old subjects with acute supratentorial ICH have higher admission hematoma volume than young and young-old subjects but do not differ for other ICH characteristics. When taking into account confounding from ICH characteristics, risk of in-SU and 1-year mortality in elderly subjects with acute supratentorial ICH does not differ across age categories. Our findings question use of age as an independent criterion for stratification of mortality risk in elderly subjects with acute ICH.

Abstract 2618: Blood Brain Barrier Permeability Increases in Intracerebral Hemorrhage do not Predict Perihematoma Edema Growth

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Sana Vahidy ◽  
Rebecca McCourt ◽  
E B Gould ◽  
Deepak Gupta ◽  
Umair Mushtaq ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Blood Brain Barrier ◽  
Symptom Onset ◽  
Volume Growth ◽  
Brain Barrier ◽  
Hematoma Expansion ◽  
Hematoma Volume ◽  
Edema Volume ◽  
Blood Brain ◽  
Bbb Permeability

Background: The etiology of edema in intracerebral hemorrhage (ICH) is controversial. Most studies are consistent with a vasogenic rather than cytotoxic pathophysiology. It is unknown, however, if the blood brain barrier (BBB) is compromised in ICH and to what extent this is related to either hematoma expansion or edema development. BBB permeability was measured with CT perfusion (CTP) in ICH patients. We hypothesized that perihematoma edema volume and growth would be associated with elevated permeability. We also tested the hypothesis that elevated PS would be associated with hematoma growth. Methods: Patients with ICH were assessed with CTP within 24 hours of symptom onset. Maps of BBB permeability-surface area product (PS), a measure of extravascular contrast leakage rate, were calculated from CTP source images. Mean PS was measured in regions of interest (ROI) defining the hematoma, a 1cm radial peri-hematoma region, and ipsilateral and contralateral hemispheres. The total perihematoma edema volume was also measured objectively, based on Hounsfield unit thresholds of ≤24 at the time of the CTP and 24 h later. Results: PS maps were generated in 50 patients (13 female). The median (IQR) time from symptom onset to CTP was 8.2 (12.4) h. Median hematoma volume at baseline was 16.4 (28.2) mL. Mean PS was higher in the hematoma (3.24±1.34 ml/100g/min), relative to contralateral regions (1.82±0.84 ml/100g/min, P<0.0001). PS was also elevated in the perihematoma region (2.50±1.13 ml/100g/min vs. 1.78±0.81 ml/100g/min, P<0.0001). Ipsilateral hemispheric PS was higher (2.08±1.00 ml/100g/min) than in the contralateral hemisphere (1.82±0.82 ml/100g/min, P=0.002). Acute hematoma volume did not predict PS elevations in the hematoma itself (R=0.004 [-0.01, 0.02], P=0.07) or perihematoma region (R=0.002 [-0.01, 0.01], P=0.74). Linear regression indicated that acute edema volume was not predicted by perihematoma PS (R=-0.68 [-2.15, 0.79], P=0.36). Follow-up CT scans at a median of 22.5 (IQR=2.4) h after the baseline CTP were obtained in 43 patients. Median perihematoma edema volume increased from 1.9 (2.6) mL to 3.2 (5.0) mL (P=<0.0001). This edema volume growth was not predicted by the acute perihematoma PS (R=0.03 [-1.62, 1.68], P=0.98). Significant hematoma expansion (>6 ml) was seen in 5 patients. There was a non-significant trend to higher median hematoma PS values in these 5 patients (3.7 (1.9) vs. 2.7 (1.7) in those with stable hematoma volumes, P=0.09). Conclusions: Small elevations in BBB permeability in and around the hematoma are common in ICH and do not appear to be related to hematoma volume. Neither acute perihematoma edema volume or edema growth is explained by BBB compromise. A relationship between elevated intra-hematoma permeability and significant hematoma expansion cannot be excluded and should be explored in a larger ICH population.

Abstract WP418: Characteristic of Intracerebral Hemorrhage Related to Direct Oral Anticoagulant versus Warfarin: Results From the PASTA Registry

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Satoshi Suda ◽  
Yasuyuki Iguchi ◽  
Shigeru Fujimoto ◽  
Yoshiki Yagita ◽  
Takayuki Mizunari ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Oral Anticoagulant ◽  
Hematoma Expansion ◽  
Direct Oral Anticoagulant ◽  
Registry Study ◽  
Stroke Patients ◽  
Hematoma Volume ◽  
Imaging Characteristics ◽  
Warfarin Treatment ◽  
Patient Enrollment

Background and Purpose: The characteristics of direct oral anticoagulant (DOAC)-related intracerebral hemorrhage (ICH) have not been fully clarified. We planned to recruit patients prospectively and to investigate the characteristics and outcomes in patients with ICH receiving direct oral anticoagulant (DOAC) and warfarin treatment. Methods: The prospective analysis of stroke patients taking anticoagulants (PASTA) registry study is an observational, multicenter, prospective registry of stroke patients receiving OAC. Patient enrollment started in April 2016 at 25 tertiary centers across Japan. We compared imaging, clinical characteristics, and discharge modified Rankin Scale (mRS) between DOAC- and warfarin-related ICH patients with atrial fibrillation (AF). Results: A total of 154 patients (51 women; median age 77 [quartiles 69-87] years) were analyzed. Of these, 111 patients (72%) received prior DOAC treatment and the remaining 43 (28%) received prior warfarin treatment (Fig. A, B and C). There were no relevant differences in clinical and hematoma characteristics between DOAC- and warfarin-related ICH regarding baseline hematoma volume (median [quartiles]: DOAC, 11 [5-23] mL vs. warfarin, 12 [5-30] mL; P =0.95), rate of hematoma expansion (DOAC, 12/111 [11%] vs. warfarin, 4/43 [9%]; P =0.80), rate of subcortical hemorrhage (DOAC, 15/111 [11%] vs. warfarin, 10/43 [9%]; P =0.80) and the proportion of patients with unfavorable outcome (mRS, 4-6: DOAC 76/108 [70%] vs. warfarin 23/38 [61%]; P =0.26). Cerebral microbleeds (CMBs) were detected more frequently in DOAC group than in warfarin (47/76 [62%] vs. 11/32 [34%]; P <0.01). Subgroup analyses showed that type of DOAC agent did not result in relevant differences in imaging characteristics or outcome (Fig. D and E). Conclusions: Our results showed that there were no significant differences in hematoma characteristics and functional outcome among AF patients with DOAC- or warfarin-related ICH.

Abstract 3543: Imaging Correlates of Early Neurologic Deterioration among Patients with Intracerebral Hemorrhage

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Nerses Sanossian ◽  
Adrian M Burgos ◽  
David S Liebeskind ◽  
Sidney Starkman ◽  
Pablo Villablanca ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Hematoma Expansion ◽  
Hematoma Volume ◽  
Phase 3 ◽  
Neurologic Deterioration ◽  
Irregular Border ◽  
History Of ◽  
Initial Imaging ◽  
Fazekas Scale ◽  
Frequent Presence

Background: Early neurologic deterioration (END) occurs commonly in intracerebral hemorrhage (ICH) patients being transported by EMS ambulances, but the imaging correlates of END have not been previously delineated. Methods: We analyzed consecutive ICH patients in the Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial, a phase 3, multicenter of paramedic-initiated magnesium sulfate vs. placebo for stroke patients presenting within 2 hours of symptom onset. END was defined as a 2-point or greater decrease in the Glasgow Coma Scale (GCS) from paramedic evaluation to ED evaluation. Baseline imaging studies were independently analyzed by 2 neurologists for ICH location, volume, presence of intraventricular hemorrhage (IVH), heterogeneity (defined as >20 point difference in Hounsfield units), irregular hematoma borders, multilobulated appearance, and substantial edema (defined as >0.5cm thickness). Leukoaraiosis was graded using the Fazekas scale for periventricular and deep white matter changes (0-3 for each). Results: Among 127 patients, mean age was 66 (SD 14) years, 34% were women, 35% were Hispanic ethnicity, 83% white, and 84% had a history of HTN. Patients were evaluated by paramedics a median of 23 (IQR 16, 39) minutes after last known well time (LKWT). At that time, the median GCS was 15 (IQR 15-15) and mean SBP/DBP was 177/95 (SD 34/22). Initial post-arrival brain imaging was performed a median of 94 (IQR 77, 117) min after LKWT. Post-arrival study GCS scores were obtained at a median of 108 (IQR 70, 144) min after LWKT. Early neurologic deterioration occurred in 37 (29%) patients. Among these patients, median first ED GCS was 3 (IQR 3-10). On first imaging, compared with neurologically stable patients, END patients had larger hematoma volume (33 cc v 16 cc, p<0.0001), and more frequent presence of intraventricular extension (45% v 20%, p=0.003), midline shift (58% v 22%), substantial edema (54% v 26%, p=0.038), heterogeneous density (50% v 22%, p=0.006), multilobulated appearance (44% v 18%, p=0.002), and irregular border (39% v 14%, p=0.010). Leukoaraiosis and cortical v subcortical location did not affect rates of END. In multivariate analysis, hematoma volume and presence of IVH were imaging findings independently associated with early neurologic deterioration. Conclusions: About 3 in 10 patients with hyperacute ICH neurologically deteriorate during the prehospital and early emergency department course, often before neuroimaging is obtained. Patients with early neurologic deterioration have larger hematoma volume and occurrence of IVH on initial imaging. These findings suggest hematoma expansion prior to ED arrival drives early neurologic deterioration in ICH and emphasize the need for prehospital interventions.

Abstract TP291: Hematoma Retraction and Perihematoma Hypodensity in Neutral Brain Model of Intracerebral Hemorrhage

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Shahram Majidi ◽  
Basit Rahim ◽  
Sarwat I Gilani ◽  
Waqas I Gilani ◽  
Malik M Adil ◽  
...  
Keyword(s):  
Biological Activity ◽  
Intracerebral Hemorrhage ◽  
Ct Scan ◽  
Early Period ◽  
Ct Scans ◽  
Hematoma Expansion ◽  
Human Cadaver ◽  
Fresh Blood ◽  
The Right

Background: The temporal evolution of intracerebral hematomas and perihematoma edema in the ultra-early period on computed tomographic (CT) scans in patients with intracerebral hemorrhage (ICH) is not well understood. We aimed to investigate hematoma and perihematoma changes in “neutral brain” models of ICH. Methods: One human and 6 goat cadaveric heads were used as “neutral brains” to provide physical properties of the brain without any biological activity or new bleeding. ICH was induced by slow injection of 4 ml of fresh blood into the right basal ganglia of the goat brains. Similarly, 20 ml of fresh blood was injected deep into the white matter of the human cadaver head in each hemisphere. Serial CT scans of the heads were performed at 0, 1, 3, and 5 hours after inducing ICH. Analyze software (AnalyzeDirect, Overland Park, KS) was used to measure hematoma and perihematoma hypodensity volumes in the baseline and follow up CT scans. Results: The initial hematoma volumes of 11.6 ml and 10.5 ml in the right and the left hemispheres of the human cadaver brain gradually decreased to 6.6 ml and 5.4 ml at 5 hours, showing 43% and 48% retraction of hematoma, respectively. The volume of the perihematoma hypodensity in the right and left hemisphere increased from 2.6 ml and 2.2 ml in the 1 hour follow up CT scans to 4.9 ml and 4.4 ml in the 5 hour CT scan, respectively. Hematoma retraction was also observed in all six ICH models in the goat brains. The mean ICH volume in the goat heads was decreased from 1.49 ml in the baseline CT scan to 1.01 ml in the 5 hour follow up CT scan showing 29.6% hematoma retraction. Perihematoma hypodensity was visualized in 70% of ICH in goat brains, with an increasing mean hypodensity volume of 0.4 ml in the baseline CT scan to 0.8 ml in the 5 hour follow up CT scan. Conclusion: Our study demonstrated that substantial hematoma retraction and perihematoma hypodensity occurs in intracerebral hematomas in the absence of any new bleeding or biological activity of the surrounding brain. Such observations suggest that active bleeding is underestimated in patients with no or small hematoma expansion and our understanding of perihematoma hypodesity needs to be reconsidered.

scholarly journals Mediation effects of mean Hounsfield unit on relationship between hemoglobin and expansion of intracerebral hemorrhage

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yong Soo Kim ◽  
Han-Gil Jeong ◽  
Hee-Yun Chae ◽  
Beom Joon Kim ◽  
Jihoon Kang ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Mediation Analysis ◽  
Hounsfield Unit ◽  
Mediation Effect ◽  
Hematoma Expansion ◽  
Hematoma Volume ◽  
Mediation Effects ◽  
Potential Marker ◽  
Baseline Systolic Blood Pressure ◽  
The Mean

AbstractLow hemoglobin levels are known to be associated with hematoma expansion (HE) and poor functional outcome in patients with intracerebral hemorrhage (ICH). However, it is not yet known whether low hemoglobin itself causes HE directly or is merely a confounder. Thus, we investigated the mediation effect of the mean Hounsfield unit (HU) of hematoma on the relationship between low hemoglobin and expansion of ICH. Overall, 232 consecutive patients with ICH who underwent non-contrast computed tomography (NCCT) within 12 h since onset were included. The mean HU and hematoma volume on NCCT were investigated using semi-automated planimetry. HE was defined as an increase in hematoma volume > 33% or 6 mL. The respective associations among the hemoglobin level, mean HU, and HE were analyzed using multivariable regression analysis, adjusting for age, sex, and known HE predictors. Mediation analysis was performed to examine the potential causal association among the three. HE occurred in 34.5% of patients; hemoglobin levels were inversely associated with HE occurrence (adjusted odds ratio, 0.90; p = 0.03). The mean HU of the hematoma was lower in patients with HE than in patients without HE (58.5 ± 3.3 vs. 56.8 ± 3.0; p < 0.01). Hemoglobin levels on admission were linearly related to the mean HU (adjusted β, 0.33; p < 0.01) after adjusting for known HE predictors (time from onset to CT, antithrombotic use, hematoma volume). Causal mediation analysis showed a significant mediation effect of the mean HU on the association between hemoglobin levels and HE (p = 0.04). The proportion of indirect effect through the mean HU among the total effect was 19% (p = 0.05). The mediation effect became nonsignificant in the when the multivariable model was adjusted with additional covariates (baseline systolic blood pressure and hematoma location). The mean HU of the hematoma mediated the association between hemoglobin levels and HE occurrence. Therefore, the mean HU of the hematoma may be a potential marker of impaired hemostasis in patients with ICH.

Abstract TP358: Prehospital Diagnosis of Intracerebral Hemorrhage in a Mobile Stroke Treatment Unit

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Daniel Vela-Duarte ◽  
Ramnath Santosh Ramanathan ◽  
Atif Zafar ◽  
Ather Taqui ◽  
Stacey Winners ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Hematoma Expansion ◽  
Hospital Treatment ◽  
Treatment Team ◽  
Hematoma Volume ◽  
Treatment Unit ◽  
Stroke Treatment ◽  
Imaging Characteristics ◽  
Mobile Stroke Unit ◽  
The Impact

Introduction: The mobile stroke unit (MSTU) is an on-site pre-hospital treatment team that incorporates laboratory and CT scanner and reduces times to treatment for ischemic stroke thrombolysis. The impact of MSTU on treatment and outcomes of intracerebral hemorrhage (ICH) remains unknown. We report our initial experience with ICH encountered on MSTU. Hypothesis: ICH can be quickly identified using MSTU. Hypertension and coagulopathy are common in ICH evaluated on MSTU. Methods: We identified ICH cases from the prospectively collected database encounters. Demographics, clinical features, MSTU imaging and repeat imaging characteristics were reviewed. Initial and follow-up hematoma volume was calculated by the ABC/2 method. Results: Of 295 encounters on MSTU from July 2014 to July 2015, 20 (6.7%) had intracranial hemorrhage, which comprised of 17 intracerebral, 1 subarachnoid and 2 subdural hemorrhages. Median time to CT diagnosis of ICH from emergency medical dispatch was 31 minutes (interquartile range (IQR) 28-36) and that from last known well was 118 minutes (IQR 39-301). Of the 17 ICH patients, 15 (88%) were hypertensive, with a mean systolic blood pressure of 178.1 and diastolic 91.0 mm Hg. Five (29.4%) individuals were found with INR>1.4, 1 of whom received 4-factor prothrombin complex concentrate. Median NIH Stroke Scale was 11 (IQR 7.5-14.5), and median hematoma volume was 10.7 cc (IQR 4.3-30.8). One patient had significant hematoma expansion as defined by >6 cc or 33% relative volume increase. Conclusions: Over 5% of the cases evaluated in the unit presented with ICH, most of whom were hypertensive and had small hematoma volume. MSTU enables early diagnosis of ICH after activation of emergency system, can provide early treatment, and appropriate triage.

Abstract TP308: Reduced Estimated Glomerular Filtration Rate And Outcomes Of Intracerebral Hemorrhage: The SAMURAI-ICH Study

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
TETSUYA MIYAGI ◽  
Masatoshi Koga ◽  
Hiroshi Yamagami ◽  
Satoshi Okuda ◽  
Yasushi Okada ◽  
...  
Keyword(s):  
Glomerular Filtration Rate ◽  
Intracerebral Hemorrhage ◽  
Glomerular Filtration ◽  
Filtration Rate ◽  
Hematoma Expansion ◽  
Hematoma Volume ◽  
Nihss Score ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background and Purpose: The association between chronic kidney disease and clinical outcomes in acute intracerebral hemorrhage (ICH) remains uncertain. We aimed to assess associations of renal dysfunction and outcomes in acute ICH patients treated with intensive BP lowering. Methods: The SAMURAI-ICH study was a prospective, multicenter, observational study. A total of 211 patients with acute supratentorial ICH were recruited. BP was targeted between 120 mmHg and 160 mmHg during initial 24 h using intravenous nicardipine. Glomerular filtration rate (eGFR) was calculated using admission serum creatinine. After 23 patients on maintenance hemodialysis were excluded, the remaining 188 were divided into 3 groups as follows: Group 1, eGFR of <60; Group 2, 60 to 75; and Group 3, ≥75 mL/min/1.73m 2 . Clinical outcomes were hematoma expansion of ≥33% at 24 h, neurological deterioration within 72 h (GCS decrement ≥2 points or NIHSS increment ≥4 points), and favorable (modified Rankin Scale [mRS] ≤2) and unfavorable (mRS ≥5) outcomes at 3 months. Results: Of 188 patients, 35 (18 women) were allocated to Group 1, 58 (20) to Group 2, and 95 (33) to Group 3. Significant differences among 3 groups were found in age (73.1±13.6, 63.3±13.2, 63.8±9.8 yo; p <0.001) and initial systolic BP (208.9±18.1, 201.2±15.6, 200.2±14.8 mmHg; p=0.018). Initial hematoma volume (14.9±11.9, 15.5±14.9, 14.3±12.3 mL) and initial median NIHSS score (14, 11, 13) were similar among 3 groups. For outcomes, significant differences among 3 groups were found in favorable outcome (17.7%, 51.7%, 41.3%; p=0.004) and unfavorable outcome (22.9%, 10.3%, 5.3%; p=0.021), but not in hematoma expansion (17.1%, 10.3%, 22.1%) and neurological deterioration (11.4%, 8.6%, 7.4%). After adjustment with initial hematoma volume, initial systolic BP and initial NIHSS score, eGFR <60 ml/min/1.73m 2 was inversely associated with favorable outcome (OR 0.20, 95% CI 0.07-0.54) and positively associated with unfavorable outcome (4.27, 1.36-13.53). Conclusions: Although decreased eGFR on admission was not associated with initial hematoma volume or initial NIHSS score, it was associated with poor outcomes at 3 months of ICH onset.

CT Scan Hematoma Volume: A Surrogate Endpoint for the Effect of Treatment in Intracerebral Hemorrhage

NeuroRx ◽  
2006 ◽  
Vol 3 (3) ◽  
pp. 413-413
Author(s):  
B SKOLNICK ◽  
S DAVIS ◽  
N BRUN ◽  
S MATHEW ◽  
S MAYER
Keyword(s):  
Intracerebral Hemorrhage ◽  
Ct Scan ◽  
Surrogate Endpoint ◽  
Hematoma Volume ◽  
Effect Of Treatment

scholarly journals Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign

Stroke ◽  
2021 ◽  
Author(s):  
Christian Ovesen ◽  
Janus Christian Jakobsen ◽  
Christian Gluud ◽  
Thorsten Steiner ◽  
Zhe Law ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Intracerebral Hemorrhage ◽  
Tranexamic Acid ◽  
Symptom Onset ◽  
Odds Ratio ◽  
Hematoma Expansion ◽  
Spot Sign ◽  
Main Trial ◽  
Acid Versus ◽  
Acute Intracerebral Hemorrhage

Background and Purpose: The computed tomography angiography or contrast-enhanced computed tomography based spot sign has been proposed as a biomarker for identifying on-going hematoma expansion in patients with acute intracerebral hemorrhage. We investigated, if spot-sign positive participants benefit more from tranexamic acid versus placebo as compared to spot-sign negative participants. Methods: TICH-2 trial (Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage) was a randomized, placebo-controlled clinical trial recruiting acutely hospitalized participants with intracerebral hemorrhage within 8 hours after symptom onset. Local investigators randomized participants to 2 grams of intravenous tranexamic acid or matching placebo (1:1). All participants underwent computed tomography scan on admission and on day 2 (24±12 hours) after randomization. In this sub group analysis, we included all participants from the main trial population with imaging allowing adjudication of spot sign status. Results: Of the 2325 TICH-2 participants, 254 (10.9%) had imaging allowing for spot-sign adjudication. Of these participants, 64 (25.2%) were spot-sign positive. Median (interquartile range) time from symptom onset to administration of the intervention was 225.0 (169.0 to 310.0) minutes. The adjusted percent difference in absolute day-2 hematoma volume between participants allocated to tranexamic versus placebo was 3.7% (95% CI, −12.8% to 23.4%) for spot-sign positive and 1.7% (95% CI, −8.4% to 12.8%) for spot-sign negative participants ( P heterogenity =0.85). No difference was observed in significant hematoma progression (dichotomous composite outcome) between participants allocated to tranexamic versus placebo among spot-sign positive (odds ratio, 0.85 [95% CI, 0.29 to 2.46]) and negative (odds ratio, 0.77 [95% CI, 0.41 to 1.45]) participants ( P heterogenity =0.88). Conclusions: Data from the TICH-2 trial do not support that admission spot sign status modifies the treatment effect of tranexamic acid versus placebo in patients with acute intracerebral hemorrhage. The results might have been affected by low statistical power as well as treatment delay. REGISTRATION: URL: http://www.controlled-trials.com ; Unique identifier: ISRCTN93732214.

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