Background
Methods
Results
Country | Code |
---|---|
Albania | 43 |
Argentina | 29 |
Australia | 01 |
Belgium | 03 |
Brazil | 42 |
Bulgaria | 04 |
Canada | 05 |
Chile | 06 |
Czech Republic | 07 |
Denmark | 08 |
Ireland | 09 |
Finland | 10 |
France | 11 |
Georgia | 32 |
Germany | 12 |
Greece | 31 |
Hong Kong | 30 |
Hungary | 36 |
India | 37 |
Indonesia | 41 |
Israel | 13 |
Italy | 14 |
Japan | 38 |
Latvia | 39 |
Malaysia | 40 |
Netherlands | 15 |
New Zealand | 16 |
Norway | 17 |
Poland | 18 |
Portugal | 19 |
Romania | 33 |
Singapore | 34 |
Slovak Republic | 44 |
Slovenia | 20 |
South Africa | 21 |
Spain | 22 |
Sri Lanka | 23 |
Sweden | 24 |
Switzerland | 25 |
Thailand | 26 |
Turkey | 35 |
UK | 27 |
USA | 28 |
Randomisation data | |
---|---|
HOSPNUM | Hospital number |
RDELAY | Delay between stroke and randomisation in hours |
RCONSC | Conscious state at randomisation (F - fully alert, D - drowsy, U - unconscious) |
SEX | M = male; F = female |
AGE | Age in years |
RSLEEP | Symptoms noted on waking (Y/N) |
RATRIAL | Atrial fibrillation (Y/N); not coded for pilot phase - 984 patients |
RCT | CT before randomisation (Y/N) |
RVISINF | Infarct visible on CT (Y/N) |
RHEP24 | Heparin within 24 hours prior to randomisation (Y/N) |
RASP3 | Aspirin within 3 days prior to randomisation (Y/N) |
RSBP | Systolic blood pressure at randomisation (mmHg) |
RDEF1 | Face deficit (Y/N/C=can't assess) |
RDEF2 | Arm/hand deficit (Y/N/C=can't assess) |
RDEF3 | Leg/foot deficit (Y/N/C=can't assess) |
RDEF4 | Dysphasia (Y/N/C=can't assess) |
RDEF5 | Hemianopia (Y/N/C=can't assess) |
RDEF6 | Visuospatial disorder (Y/N/C=can't assess) |
RDEF7 | Brainstem/cerebellar signs (Y/N/C=can't assess) |
RDEF8 | Other deficit (Y/N/C=can't assess) |
STYPE | Stroke subtype (TACS/PACS/POCS/LACS/OTH=other) |
RDATE | Year and month of randomisation (yyyy-mm) |
HOURLOCAL | Local time - hours (99-missing data) of randomisation |
MINLOCAL | Local time - minutes (99-missing data) of randomisation |
DAYLOCAL | Estimate of local day of week; 1 - Sunday, 2-Monday, 3-Tuesday, 4-Wednesday, 5-Thursday, 6-Friday, 7-Saturday |
RXASP | Trial aspirin allocated (Y/N) |
RXHEP | Trial heparin allocated (M/L/N). The terminology for the allocated dose of unfractioned heparin changed slightly from the pilot to the main study. Patients were allocated either 12500 units subcutaneously twice daily (coded as H in the pilot and M in the main trial), 5000 units twice daily (coded as L throughout) or to 'avoid heparin' (coded as N throughout). |
Data collected on 14 day/discharge form about treatments given in hospital
| |
DASP14 | Aspirin given for 14 days or till death or discharge (Y/N/U=unknown) |
DASPLT | Discharged on long term aspirin (Y/N/U=unknown) |
DLH14 | Low dose heparin given for 14 days or till death/discharge (Y/N/U=unknown) |
DMH14 | Medium dose heparin given for 14 days or till death/discharge (Y/N/U=unknown) |
DHH14 | Medium dose heparin given for 14 days etc in pilot (combine with above; Y/N) |
ONDRUG | Estimate of time in days on trial treatment |
DSCH | Non trial subcutaneous heparin (Y/N/U=unknown) |
DIVH | Non trial intravenous heparin (Y/N/U=unknown) |
DAP | Non trial antiplatelet drug (Y/N/U=unknown) |
DOAC | Other anticoagulants (Y/N/U=unknown) |
DGORM | Glycerol or manitol (Y/N/U=unknown) |
DSTER | Steroids (Y/N/U=unknown) |
DCAA | Calcium antagonists (Y/N/U=unknown) |
DHAEMD | Haemodilution (Y/N/U=unknown) |
DCAREND | Carotid surgery (Y/N/U=unknown) |
DTHROMB | Thrombolysis (Y/N/U=unknown) |
DMAJNCH | Major non-cerebral haemorrhage (Y/N/U=unknown) |
DMAJNCHD | Date of above (days elapsed from randomisation) |
DMAJNCHX | Comment on above |
DSIDE | Other side effect (Y/N/U=unknown) |
DSIDED | Date of above (days elapsed from randomisation) |
DSIDEX | Comment on above |
Final diagnosis of initial event
| |
DDIAGISC | Ischaemic stroke (Y/N/U=unknown) |
DDIAGHA | Haemorrhagic stroke (Y/N/U=unknown) |
DDIAGUN | Indeterminate stroke (Y/N/U=unknown) |
DNOSTRK | Not a stroke (Y/N/U=unknown) |
DNOSTRKX | Comment on above |
Recurrent stroke within 14 days
| |
DRSISC | Ischaemic recurrent stroke (Y/N/U=unknown) |
DRSISCD | Date of above (days elapsed from randomisation) |
DRSH | Haemorrhagic stroke (Y/N/U=unknown) |
DRSHD | Date of above (days elapsed from randomisation) |
DRSUNK | Unknown type (Y/N/U=unknown) |
DRSUNKD | Date of above (days elapsed from randomisation) |
Other events within 14 days
| |
DPE | Pulmonary embolism; (Y/N/U=unknown) |
DPED | Date of above (days elapsed from randomisation) |
DALIVE | Discharged alive from hospital (Y/N/U=unknown) |
DALIVED | Date of above (days elapsed from randomisation) |
DPLACE | Discharge destination (A-Home/B-Relatives home/C-Residential care/D-Nursing home/E-Other hospital departments/U-Unknown) |
DDEAD | Dead on discharge form (Y/N/U=unknown) |
DDEADD | Date of above (days elapsed from randomisation); NOTE: this death is not necessarily within 14 days of randomisation |
DDEADC | Cause of death (1-Initial stroke/2-Recurrent stroke (ischaemic or unknown)/3-Recurrent stroke (haemorrhagic)/4-Pneumonia/5-Coronary heart disease/6-Pulmonary embolism/7-Other vascular or unknown/8-Non-vascular/0-unknown) |
DDEADX | Comment on death |
Data collected at 6 months
| |
FDEAD | Dead at six month follow-up (Y/N/U=unknown) |
FLASTD | Date of last contact (days elapsed from randomisation) |
FDEADD | Date of death (days elapsed from randomisation); NOTE: this death is not necessarily within 6 months of randomisation |
FDEADC | Cause of death (1-Initial stroke/2-Recurrent stroke (ischaemic or unknown)/3-Recurrent stroke (haemorrhagic)/4-Pneumonia/5-Coronary heart disease/6-Pulmonary embolism/7-Other vascular or unknown/8-Non-vascular/0-unknown) |
FDEADX | Comment on death |
FRECOVER | Fully recovered at 6 month follow-up (Y/N/U=unknown) |
FDENNIS | Dependent at 6 month follow-up (Y/N/U=unknown) |
FPLACE | Place of residance at 6 month follow-up (A-Home/B-Relatives home/C-Residential care/D-Nursing home/E-Other hospital departments/U-Unknown) |
FAP | On antiplatelet drugs at six month follow-up (Y/N/U=unknown) |
FOAC | On oral anticoagulants at six month follow-up (Y/N/U=unknown) |
Other data and derived variables
| |
FU1_RECD | Date discharge form received (days elapsed from randomisation) |
FU2_DONE | Date 6 month follow-up done (days elapsed from randomisation) |
COUNTRY | Abbreviated country code |
CNTRYNUM | Country code (see Table 1) |
FU1_COMP | Date discharge form completed (days elapsed from randomisation) |
NCCODE | Coding of compliance (see Table 3) |
CMPLASP | Compliant for aspirin (N/Y) |
CMPLHEP | Compliant for heparin (N/Y) |
ID | Indicator variable for death (1 = died; 0 = did not die) |
TD | Time of death or censoring in days |
EXPDD | Predicted probability of death/dependence at 6 month |
EXPD6 | Predicted probability of death at 6 month |
EXPD14 | Predicted probability of death at 14 days |
SET14D | Know to be dead or alive at 14 days (1 = Yes, 0 = No); this does not necessarily mean that we know outcome at 6 months - see OCCODE for this |
ID14 | Indicator of death at 14 days (1 = Yes, 0 = No) |
OCCODE | Six month outcome (1-dead/2-dependent/3-not recovered/4-recovered/0 or 9 - missing status |
Indicator variables for specific causes of death
| |
DEAD1 | Initial stroke (1 = Yes, 0 = No) |
DEAD2 | Reccurent ischaemic/unknown stroke (1 = Yes, 0 = No) |
DEAD3 | Reccurent haemorrhagic stroke (1 = Yes, 0 = No) |
DEAD4 | Pneumonia (1 = Yes, 0 = No) |
DEAD5 | Coronary heart disease (1 = Yes, 0 = No) |
DEAD6 | Pulmonary embolism (1 = Yes, 0 = No) |
DEAD7 | Other vascular or unknown (1 = Yes, 0 = No) |
DEAD8 | Non vascular (1 = Yes, 0 = No) |
H14 | Cerebral bleed/heamorrhagic stroke within 14 days; this is slightly wider definition than DRSH and is used for analysis of cerebral bleeds; (1 = Yes, 0 = No) |
ISC14 | Indicator of ischaemic stroke within 14 days (1 = Yes, 0 = No) |
NK14 | Indicator of indeterminate stroke within 14 days (1 = Yes, 0 = No) |
STRK14 | Indicator of any stroke within 14 days (1 = Yes, 0 = No) |
HTI14 | Indicator of haemorrhagic transformation within 14 days (1 = Yes, 0 = No) |
PE14 | Indicator of pulmonary embolism within 14 days (1 = Yes, 0 = No) |
DVT14 | Indicator of deep vein thrombosis on discharge form (1 = Yes, 0 = No) |
TRAN14 | Indicator of major non-cerebral bleed within 14 days (1 = Yes, 0 = No) |
NCB14 | Indicator of any non-cerebral bleed within 14 days (1 = Yes, 0 = No) |
1. | Should not have been randomised |
---|---|
2. | Refused treatment |
3. | Initial event not a stroke |
4. | Haemorrhagic stroke |
5. | Non compliers |
6. | Discharged after 14 days |
7. | Discharged up to 14 days |
8. | Died prior to receiving the study drug(s) |
9. | Died after receiving the study drug(s) |
10. | Recurrent stroke/pulmonary embolism |
11. | Clinical decision |
11a. | Suspected abnormality |
11b. | Withdrawn as dying |
11c. | Pre-existing condition |
11d. | Stated abnormal PTT |
11e. | Stated surgery |
11f. | Stated atrial fibrillation |
12. | Administration problem |
13. | Missed out more than 3 doses |
14. | Side effect |
14a. | Refused treatment |
14b. | Discharged |
14c. | Administration problem |
14d. | Clinical decision |
14e. | Recurrent stroke |
14f. | Haemorrhagic stroke |
Number | |
---|---|
Ischaemic stroke | 17398 |
Haemorrhagic stroke | 599 |
Definite stroke, pathological type unknown | 992 |
Not a stroke | 420 |
Uncertain diagnosis | 26 |
Total | 19435 |