Association of prothrombin complex concentrate administration and hematoma enlargement in non–vitamin <scp>K</scp> antagonist oral anticoagulant–related intracerebral hemorrhage

Gerner, Stefan T.; Kuramatsu, Joji B.; Sembill, Jochen A.; Sprügel, Maximilian I.; Endres, Matthias; Hæusler, Karl Georg; Vajkoczy, Peter; Ringleb, Peter A.; Purrucker, Jan; Rizos, Timolaos; Erbguth, Frank; Schellinger, Peter D.; Fink, Gereon R.; Stetefeld, Henning; Schneider, Hauke; Neugebauer, Hermann; Röther, Joachim; Claßen, Joseph; Michalski, Dominik; Dörfler, Arnd; Schwab, Stefan; Huttner, Hagen B.; Investigators, Retrace

doi:10.1002/ana.25134

Cited by 124 publications

(122 citation statements)

References 39 publications

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“…As with all non‐randomised studies of this problem, we have not compared the effect of PCC with supportive care alone and so the true effect of PCC in reversing bleeding is not known. In a retrospective (non‐randomised) study of DOAC‐related ICH, PCC administration was not associated with a reduction in haematoma enlargement (Gerner et al , ) and the mortality rates, 29/146 (19·9%) at discharge ( P = 0·83) and 43/146 (29·5%) after 3 months ( P = 0·89), were not different between patients who did or did not receive PCC. However, the high mortality associated with ICH in the absence of intervention has been noted above (Hart et al , ; Hankey et al , ).…”

Section: Discussionmentioning

confidence: 97%

Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

et al. 2018

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Summary This retrospective study investigated the efficacy and safety of prothrombin complex concentrates (PCCs) for management of major bleeding events (MBE) in 344 patients receiving the anticoagulants rivaroxaban, apixaban or warfarin during the period January 2016 to April 2018. Median (range) PCC dose was 2000 units (1000–4500). Intracranial haemorrhage (ICH) was the most common indication (137/344, 39·8%) for PCC use followed by gastrointestinal bleeding (93/344, 27%). ICH patients more frequently received rivaroxaban (62·5%) or apixaban (52·5%) compared to warfarin (34·5%), P = 0·002; and visceral bleeding patients received warfarin more frequently (24·2%) than rivaroxaban (5%) or apixaban (10%), P = 0·003. Median rivaroxaban and apixaban levels were 230 ng/ml (47–759) and 159 ng/ml (45–255). Median International Normalised Ratio pre‐ and post‐PCC in patients on warfarin were 3·4 (1·9–15·4) and 1·2 (1·0–1·9). Blood products use was the same between groups. Thirty‐day mortality and re‐bleeding rates in patients with ICH were 35% (P = 0·50) and 18% (P = 0·90) with no differences between the groups. Thrombosis occurred in 4·1% patients within 30 days with no difference between groups. Two of 91 (2·2%) patients with ICH only (both on warfarin) had ischaemic strokes within 30 days post‐PCC. In conclusion, there was no difference in the safety (thrombosis) or efficacy (30‐day mortality, re‐bleeding) in use of PCC for MBE in patients on warfarin, rivaroxaban or apixaban.

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Section: Discussionmentioning

confidence: 97%

Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

et al. 2018

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“…We differentiated primary spontaneous ICH in the absence of therapeutic anticoagulation (non‐OAC‐ICH) from ICH related to oral anticoagulants. OAC‐ICH was defined as either ICH on effective treatment with vitamin‐K‐antagonists (VKA) (INR > 1.5 on hospital admission) or ICH on known treatment with non‐vitamin‐K‐antagonist oral anticoagulant (NOAC) at symptom onset . We defined early care limitations as care limitation employed during first 24 h after hospital admission …”

Section: Methodsmentioning

confidence: 99%

“…OAC-ICH was defined as either ICH on effective treatment with vitamin-K-antagonists (VKA) (INR > 1.5 on hospital admission) or ICH on known treatment with non-vitamin-K-antagonist oral anticoagulant (NOAC) at symptom onset. 3,17,21,22 We defined early care limitations as care limitation employed during first 24 h after hospital admission. 23 Imaging Imaging data were analyzed by neuroradiologist blinded to clinical data.…”

Section: Data Acquisitionmentioning

confidence: 99%

“…19 For comparison of HE occurrence in deep versus lobar ICH location (primary outcome), we separately analyzed patients with non-OAC-ICH, VKA-ICH, and NOAC-ICH to minimize confounding by established larger ICH volumes, higher HE rates, and need for reversal treatment in patients with prior anticoagulation intake. 17,30 To further address potential confounding by varying baseline characteristics and time points of imaging, we additionally performed a parallel, balanced, nearest-neighbor (1:1, caliper 0.1) propensity score matching (PSM). Due to limited numbers of patients taking NOAC, we combined cohorts of NOAC-ICH and VKA-ICH for PSM-analyses.…”

Section: Statisticsmentioning

confidence: 99%

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Hematoma enlargement characteristics in deep versus lobar intracerebral hemorrhage

Sembill¹,

Kuramatsu²,

Gerner³

et al. 2020

Ann Clin Transl Neurol

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Objective Hematoma enlargement (HE) is associated with clinical outcomes after supratentorial intracerebral hemorrhage (ICH). This study evaluates whether HE characteristics and association with functional outcome differ in deep versus lobar ICH. Methods Pooled analysis of individual patient data between January 2006 and December 2015 from a German‐wide cohort study (RETRACE, I + II) investigating ICH related to oral anticoagulants (OAC) at 22 participating centers, and from one single‐center registry (UKER‐ICH) investigating non‐OAC‐ICH patients. Altogether, 1954 supratentorial ICH patients were eligible for outcome analyses, which were separately conducted or controlled for OAC, that is, vitamin‐K‐antagonists (VKA, n = 1186) and non‐vitamin‐K‐antagonist‐oral‐anticoagulants (NOAC, n = 107). Confounding was addressed using propensity score matching, cox regression modeling and multivariate modeling. Main outcomes were occurrence, extent, and timing of HE (>33%/>6 mL) and its association with 3‐month functional outcome. Results Occurrence of HE was not different after deep versus lobar ICH in patients with non‐OAC‐ICH (39/356 [11.0%] vs. 36/305 [11.8%], P = 0.73), VKA‐ICH (249/681 [36.6%] vs. 183/505 [36.2%], P = 0.91), and NOAC‐ICH (21/69 [30.4%] vs. 12/38 [31.6%], P = 0.90). HE extent did not differ after non‐OAC‐ICH (deep:+59% [40–122] vs. lobar:+74% [37–124], P = 0.65), but both patients with VKA‐ICH and NOAC‐ICH showed greater HE extent after deep ICH [VKA‐ICH, deep: +94% [54–199] vs. lobar: +56% [35–116], P < 0.001; NOAC‐ICH, deep: +74% [56–123] vs. lobar: +40% [21–49], P = 0.001). Deep compared to lobar ICH patients had higher HE hazard during first 13.5 h after onset (Hazard ratio [HR]: 1.85 [1.03–3.31], P = 0.04), followed by lower hazard (13.5–26.5 h, HR: 0.46 [0.23–0.89], P = 0.02), and equal hazard thereafter (HR: 0.96 [0.56–1.65], P = 0.89). Odds ratio for unfavorable outcome was higher after HE in deep (4.31 [2.71–6.86], P < 0.001) versus lobar ICH (2.82 [1.71–4.66], P < 0.001), and only significant after small‐medium (1st volume‐quarter, deep: 3.09 [1.52–6.29], P < 0.01; lobar: 3.86 [1.35–11.04], P = 0.01) as opposed to large‐sized ICH (4th volume‐quarter, deep: 1.09 [0.13–9.20], P = 0.94; lobar: 2.24 [0.72–7.04], P = 0.17). Interpretation HE occurrence does not differ among deep and lobar ICH. However, compared to lobar ICH, HE after deep ICH is of greater extent in OAC‐ICH, occurs earlier and may be of greater clinical relevance. Overall, clinical significance is more apparent after small–medium compared to large‐sized bleedings.

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“…Two neuroradiologists blinded to clinical data scored ICH location, estimated the hemorrhage volume using ABC methods [14] and documented the presence and extent of IVH [15]. Hemorrhage enlargement was scored if ICH volume on follow-up imaging exceeded 33% compared to initial imaging [16].…”

Section: Imagingmentioning

confidence: 99%

Peak Troponin I Levels Are Associated with Functional Outcome in Intracerebral Hemorrhage

et al. 2018

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Background: Troponin I is a widely used and reliable marker of myocardial damage and its levels are routinely measured in acute stroke care. So far, the influence of troponin I elevations during hospital stay on functional outcome in patients with atraumatic intracerebral hemorrhage (ICH) is unknown. Methods: Observational single-center study including conservatively treated ICH patients over a 9-year period. Patients were categorized according to peak troponin I level during hospital stay (≤0.040, 0.041–0.500, > 0.500 ng/mL) and compared regarding baseline and hematoma characteristics. Multivariable analyses were performed to investigate independent associations of troponin levels during hospital stay with functional outcome – assessed using the modified Rankin Scale (mRS; favorable 0–3/unfavorable 4–6) – and mortality after 3 and 12 months. To account for possible confounding propensity score (PS)-matching (1: 1; caliper 0.1) was performed accounting for imbalances in baseline characteristics to investigate the impact of troponin I values on outcome. Results: Troponin elevations (> 0.040 ng/mL) during hospital stay were observed in 308 out of 745 (41.3%) patients and associated with poorer status on admission (Glasgow Coma Scale/National Institute of Health Stroke Scale). Multivariable analysis revealed troponin I levels during hospital stay to be independently associated with unfavorable outcome after 12 months (risk ratio [95% CI]: 1.030 [1.009–1.051] per increment of 1.0 ng/mL; p = 0.005), but not with mortality. After PS-matching, patients with troponin I elevation (≥0.040 ng/mL) versus those without had a significant higher rate of unfavorable outcome after 3 and 12 months (mRS 4–6 at 3 months: < 0.04 ng/mL: 159/265 [60.0%] versus ≥0.04 ng/mL: 199/266 [74.8%]; p < 0.001; at 12 months: < 0.04 ng/mL: 141/248 [56.9%] versus ≥0.04 ng/mL: 179/251 [71.3%]; p = 0.001). Conclusions: Troponin I elevations during hospital stay occur frequently in ICH patients and are independently associated with functional outcome after 3 and 12 months but not with mortality.

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Association of prothrombin complex concentrate administration and hematoma enlargement in non–vitamin K antagonist oral anticoagulant–related intracerebral hemorrhage

Cited by 124 publications

References 39 publications

Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

Efficacy and safety of prothrombin complex concentrate in patients treated with rivaroxaban or apixaban compared to warfarin presenting with major bleeding

Hematoma enlargement characteristics in deep versus lobar intracerebral hemorrhage

Peak Troponin I Levels Are Associated with Functional Outcome in Intracerebral Hemorrhage

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