SITS - Thrombolysis

Summary

This registry records the use of IV thrombolysis in the treatment of stroke.

SITS protocols are electronic forms that are automatically enabled in the registry depending on the chosen acute phase intervention. In this registry the following protocols are used:  

Intravenous Thrombolysis Protocol, standard version (IVTP-s) – protocol for registering stroke patients treated with IV thrombolysis.

Intravenous Thrombolysis Protocol, minimal version (IVTP-m) - protocol for registering all stroke patients treated with IV thrombolysis. The minimal version omits certain variables at various time points, making the protocol less extensive compared to IVTP-s.

 

SITS Thrombolysis Registry  

Data based on all patient files entered between December 25, 2002 and November 19, 2016 using the standard and minimal SITS IV Thrombolysis protocols. Patient recruitment is calculated using files with both confirmed and unconfirmed data.

Figure 1. Cumulative and annual registration of patients using IV thrombolysis data forms

 

 

Table 1. Demographic and baseline clinical characteristics in IVT treated patients with confirmed data

Characteristic

Median

Characteristic

Proportion

Age, years

71

Female

45%

NIHSS Baseline

11

Atrial fibrillation

23%

Systolic BP, mmHg

150

Hypertension

66%

Diastolic BP, mmHg

81

Diabetes

19%

Glucose, mmol/L

6,6

Hyperlipidemia

32%

Cholesterol, mmol/L

4,8

Heart failure

8%

Weight, kg

75

Smoker, current

19%

Dose Of Actilyse, mg

68

Smoker, previous

17%

 

 

Previous stroke

8%

Time logistics, minutes

Median

Previous TIA

7%

 

 

Pre-stroke mRS 0-1

88%

Onset To Door

75

Aspirin

32%

Door To Imaging

25

Clopidogrel

5%

Door To Treatment

65

Oral anticoagulant

3%

Onset To Treatment

150

Statin

28%

 

 

Antihypertensive

56%

 

Table 2. Proportions of patients with intracerebral hemorrhage

ICH

Proportion

SICH

Proportion

HI1

4,5%

SITS-MOST

1,7%

HI2

3,1%

ECASS II

4,5%

PH1

2,6%

NINDS

6,3%

PH2

2,7%

   

PHr1

1,9%

   

PHr2

1,0%

   

 

In this table, we present the frequency of intracerebral hemorrhage (ICH) of various types, and of symptomatic intracerebral haemorrhage (SICH) by three definitions, in patients treated with IV thrombolysis.

 

ICH Definitions

Hemorrhagic infarction type 1 (HI1): small petechiae along the margins of the infarct.

Hemorrhagic infarction type 2 (HI2): confluent petechiae within the infarcted area without space-occupying effect.

Parenchymal hemorrhage type 1 (PH1): local, or intra-ischemic confluent hematoma in ≤ 30% of the infarcted area with at the most some slight space-occupying effect.

Parenchymal hemorrhage type 2 (PH2): local, or intra-ischemic confluent hematoma >30% of the infarcted area with a substantial space-occupying effect.

Remote parenchymal hemorrhage type 1 (PHr1): small to medium sized hematoma located remote from the infarct(s), with mild space occupying effect.

Remote parenchymal hemorrhage type 2 (PHr2): large confluent hematoma in an area remote from the actual infarct(s), with substantial space occupying effect.

 

SICH Definitions

SICH per SITS-MOST: Local or remote parenchymal haemorrhage type 2 on the 22-36 h post-treatment imaging scan, combined with a neurologic deterioration of 4 points or more compared to baseline NIHSS or the lowest NIHSS value between baseline and 24 h or death within 24 h. Type 2 indicates a hematoma exceeding 30% of the infarct, with substantial space-occupying effect.

SICH per ECASS II: Any haemorrhage with neurologic deterioration as indicated by an increase in NIHSS ≥4 compared to baseline or the lowest value within 7 days, or any haemorrhage leading to death.

SICH per NINDS: Any intracerebral haemorrhage on any

post-treatment imaging scans combined with any decline in neurologic status as measured by NIHSS between baseline and 7d.

 

Figure 2. Outcome at 3 month in IVT treated patients 

Outcomes in patients treated with IV thrombolysis. Data show the distribution of patients on the modified Rankin Scale (mRS) as assessed at three months after the acute stroke.

 

Table 3. Outcome at 3 month in IVT treated patients 

Outcome within 3 months

Proportion

Excellent outcome (mRS 0-1)

40,6%

Functional independence (mRS 0-2)

55,4%

Death                                                         

16,6%