The Cologne stroke experience: safety and outcome in 450 patients treated with intravenous thrombolysis

Cerebrovasc Dis. 2007;24(1):56-65. doi: 10.1159/000103117. Epub 2007 May 22.

Abstract

Background: Predictors of outcome and safety in intravenous thrombolysis within 3 h in clinical routine is a matter of ongoing debate. Available reports contain small patient numbers or summarize heterogeneous multicenter data.

Methods: Four hundred and fifty patients received intravenous thrombolysis within 3 h after stroke. Pretreatment NIHSS score and detailed medical history were analyzed. Noncontrast CT was performed before thrombolysis, 24-36 h later and in case of clinical deterioration. Symptomatic intracranial hemorrhage (SICH; any bleeding with an NIHSS increase of > or =4 points) and clinical outcome (modified Rankin Scale, mRS) after 3 months were recorded. Logistic regression identified parameters predictive of independence (mRS 0-2) and SICH.

Results: Median onset to admission, door to needle and onset to treatment time was 75, 50 and 135 min, respectively. Direct presentation by emergency service (64%) was the fastest way of referral. Median pretreatment NIHSS was 11 points. Independence (mRS 0-2) was reached by 53%. Mortality was 11% (7% intracerebral, 4% extracerebral complications). Logistic regression identified low NIHSS, low age and absent diabetes as predictors of independence. Overall hemorrhagic complications and SICH were found in 18 and 4% of the patients, respectively. Extracerebral bleeding complications and allergic reactions were found in 3 and 1%, respectively.

Conclusion: This largest single center report presents a sample in the range of the 3 h rt-PA cohort of all randomized controlled trials. Outcome was comparable to randomized studies with a higher rate of independence and a lower rate of mortality and SICH.

Publication types

  • Clinical Trial

MeSH terms

  • Activities of Daily Living
  • Aged
  • Female
  • Fibrinolytic Agents / administration & dosage
  • Fibrinolytic Agents / adverse effects
  • Fibrinolytic Agents / therapeutic use*
  • Germany
  • Hemorrhage / chemically induced
  • Humans
  • Infusions, Intravenous
  • Intracranial Hemorrhages / chemically induced
  • Logistic Models
  • Male
  • Middle Aged
  • Odds Ratio
  • Recombinant Proteins / therapeutic use
  • Recovery of Function / drug effects
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Stroke / drug therapy*
  • Stroke / mortality
  • Stroke / physiopathology
  • Thrombolytic Therapy*
  • Time Factors
  • Tissue Plasminogen Activator / administration & dosage
  • Tissue Plasminogen Activator / adverse effects
  • Tissue Plasminogen Activator / therapeutic use*
  • Treatment Outcome

Substances

  • Fibrinolytic Agents
  • Recombinant Proteins
  • Tissue Plasminogen Activator