BACKGROUND:Intracerebral hemorrhage (ICH) is an infrequent complication of intravenous recombinant tissue plasminogen activator (rt-PA) for the treatment of acute stroke. However, such ICH is an important reason for withdrawal of care because of lack of adequate data regarding long-term patient outcomes. OBJECTIVE: To report the long-term outcomes in patients with post-thrombolytic ICH. METHODS: We analyzed patient data from a randomized, placebo-controlled trial in patients with ischemic stroke presenting within 3 h of symptom onset. Baseline clinical characteristics and outcomes defined by modified Rankin scale (mRS) were ascertained at 3, 6, and 12 months after treatment in patients who suffered from post-thrombolytic ICH. Favorable outcome was defined by mRS of 0-3 and unfavorable outcome by mRS of 4-6 at 1 year. RESULTS: A total of 48 patients suffered post-thrombolytic ICH in the trial. Fourteen patients had favorable outcomes and 34 patients had unfavorable outcomes. Clinical characteristics did not have an impact on patient outcomes at 12 months. Patients with unfavorable outcomes were more likely to have an National Institutes of Health Stroke Scale (NIHSS) score ≥ 20 at 7-10 days after treatment (64 vs. 7 %, p < 0.0009). Patients with unfavorable outcomes were more likely to have a worsening of NIHSS score of >4 points at 7-10 days from their baseline NIHSS (44 vs. 0 %, p = 0.0006). CONCLUSION: Approximately 30 % of patients with post-thrombolytic ICH have favorable outcomes at 1 year which does not support early withdrawal of care. Ascertainment of NIHSS score and worsening of NIHSS score at 7-10 days may be necessary for accurate prognostic stratification.
RCT Entities:
BACKGROUND:Intracerebral hemorrhage (ICH) is an infrequent complication of intravenous recombinant tissue plasminogen activator (rt-PA) for the treatment of acute stroke. However, such ICH is an important reason for withdrawal of care because of lack of adequate data regarding long-term patient outcomes. OBJECTIVE: To report the long-term outcomes in patients with post-thrombolytic ICH. METHODS: We analyzed patient data from a randomized, placebo-controlled trial in patients with ischemic stroke presenting within 3 h of symptom onset. Baseline clinical characteristics and outcomes defined by modified Rankin scale (mRS) were ascertained at 3, 6, and 12 months after treatment in patients who suffered from post-thrombolytic ICH. Favorable outcome was defined by mRS of 0-3 and unfavorable outcome by mRS of 4-6 at 1 year. RESULTS: A total of 48 patients suffered post-thrombolytic ICH in the trial. Fourteen patients had favorable outcomes and 34 patients had unfavorable outcomes. Clinical characteristics did not have an impact on patient outcomes at 12 months. Patients with unfavorable outcomes were more likely to have an National Institutes of Health Stroke Scale (NIHSS) score ≥ 20 at 7-10 days after treatment (64 vs. 7 %, p < 0.0009). Patients with unfavorable outcomes were more likely to have a worsening of NIHSS score of >4 points at 7-10 days from their baseline NIHSS (44 vs. 0 %, p = 0.0006). CONCLUSION: Approximately 30 % of patients with post-thrombolytic ICH have favorable outcomes at 1 year which does not support early withdrawal of care. Ascertainment of NIHSS score and worsening of NIHSS score at 7-10 days may be necessary for accurate prognostic stratification.
Authors: W Hacke; M Kaste; C Fieschi; R von Kummer; A Davalos; D Meier; V Larrue; E Bluhmki; S Davis; G Donnan; D Schneider; E Diez-Tejedor; P Trouillas Journal: Lancet Date: 1998-10-17 Impact factor: 79.321
Authors: Werner Hacke; Geoffrey Donnan; Cesare Fieschi; Markku Kaste; Rüdiger von Kummer; Joseph P Broderick; Thomas Brott; Michael Frankel; James C Grotta; E Clarke Haley; Thomas Kwiatkowski; Steven R Levine; Chris Lewandowski; Mei Lu; Patrick Lyden; John R Marler; Suresh Patel; Barbara C Tilley; Gregory Albers; Erich Bluhmki; Manfred Wilhelm; Scott Hamilton Journal: Lancet Date: 2004-03-06 Impact factor: 79.321