SEDAN Score for Post-tPA Hemorrhage
Applies to patients receiving tPA within 4.5 hours; does not apply to patients receiving endovascular treatment.
- Providing actual estimates of risk of tPA to patients and their family members.
- Weighing risk of benefit and risk of harm in minor or severe strokes.
- The SEDAN Score predicts risk of post-tPA hemorrhage.
- tPA hemorrhage risk varies greatly, so its developers wanted to predict low- and high-risk patients.
- The endpoint, “Symptomatic Intracerebral Hemorrhage” varies greatly from trial to trial depending on definition, making it difficult to compare outcomes.
- The HAT Score also predicts risk of sICH with fewer variables.
- The THRIVE Score predicts chance of good outcome after stroke (even without tPA) and does not require imaging variables.
Points to Consider
- Patients in this score did not receive endovascular therapy.
- sICH increases mortality dramatically.
- tPA risks and benefits should be very clearly discussed and documented with patients and family members.
With rates of sICH varying widely, the SEDAN Score can help predict which patients will be at low or high risk to go on to have sICH, which increases mortality dramatically.
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- Consider tPA contraindications closely, as institutions may have slightly different definitions of contraindications (absolute and relative).
- tPA for stroke should only be given in conjunction with Neurology consultation and after extensive discussion with the patient and family about risk and benefit.
- Patients receiving tPA should be monitored in an ICU setting.
- Even in low-risk patients, patients with changing neurologic exams or mental status should receive emergent re-imaging to assess for sICH.
- Consider other bleeding sites (GI, GU, for example) in post-tPA patients and exercise caution with even minimally invasive procedures such as venipuncture or foley catheter placement.
Addition of assigned points, as above.
Facts & Figures
|SEDAN Score||Risk of Symptomatic ICH|
- Developed in Europe
- Derived from 974 patients treated with tPA within 4.5 hours
- Basilar artery occlusion patients were not included in the study (but were separately evaluated later)
- Patients undergoing endovascular procedures for their stroke were also excluded from the study
- The ECASS-II definition of sICH was used:
- An intracranial hemorrhage was defined as symptomatic if the patient had clinical deterioration causing an increase in the NIHSS score of more than or equal to 4 points and if the hemorrhage was likely to be the cause of the clinical deterioration. However, in case of doubt regarding whether edema or hemorrhage was the leading pathology, an association of the hemorrhage with the deterioration was assumed.
- The score was then internally validated in 828 patients.
- Overall 7% of patients in the study developed sICH
- The SEDAN Score was validated in 34,251 patients
- In the validation study they used both the ECASS-II definition of sICH as well as the SITS-MOST definition of sICH:
- Presence of parenchymal hemorrhage type 2 on CT with an NIHSS score increased by ≥4 points from baseline or the lowest NIHSS value after baseline to 24 hours
- The SITS-MOST definition of sICH is more narrow than the ECASS-II definition, so many fewer patients will be defined as having sICH.
Original/Primary ReferenceStrbian D, Engelter S, Michel P, Meretoja A, Sekoranja L, Ahlhelm FJ, Mustanoja S, Kuzmanovic I, Sairanen T, Forss N, Cordier M, Lyrer P, Kaste M, Tatlisumak T.Symptomatic intracranial hemorrhage after stroke thrombolysis: the SEDAN score. Ann Neurol. 2012 May;71(5):634-41. doi: 10.1002/ana.23546.
ValidationMazya MV, Bovi P, Castillo J, Jatuzis D, Kobayashi A, Wahlgren N, Ahmed N. External validation of the SEDAN score for prediction of intracerebral hemorrhage in stroke thrombolysis. Stroke. 2013 Jun;44(6):1595-600. doi: 10.1161/STROKEAHA.113.000794. Epub 2013 Apr 30.
About the Creator
Daniel Strbian, MD, PhD, is a practicing neurologist at the University of Helsinki Central Hospital in Finland. He is an active researcher in the field of ischemic stroke.
To view Dr. Daniel Strbian's publications, visit PubMed