Stroke: immediate anticoagulation had no clear effect on recurrent embolic stroke.

Clinical bottom line (level 1b-)

  1. Patients with an embolic stroke who were given immediate anticoagulation had no clear difference in recurrent embolism, haemorrhagic infarction or death, than those not given immediate anticoagulation.
Cerebral Embolism Study Group : Stroke 1983; 14 (5): 668-676
Expires June 2003

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 4 academic centres, USA

45 patients (aged range 42 to 83 years; mean 65, 58% male) sudden, focal brain infarction compattible with cardiogenic embolism with a clinical diagnosis of the source of embolism

Excluded if
  • ancillary investigations not completed within 48 hours
  • pregnancy
  • bloody or xanthochromic cerebrospinal fluid
  • persistent hypertension >180/115 mmHg
  • active peptic ulcer disease or occult blood in the stool
  • haemorrhagic infarction on initial CT
  • serum creatinine >4.0 mg/dl
  • severe anaemia (<9 gm/dl) or thrombocytopenia
  • aged over 78 years
  • history of heparin allergy or prior adverse reaction to heparin
  • age <18 years or mentally incompetent
  • therapeutic anticoagulation (prothrombin time >1.5 times control) with coumadin at the time of stroke


    • Control Group: (n = 21, 21 analysed): no anticoagulation for 10 days
    Experimental Group: (n = 24, 24 analysed): immediate (within 48 hours of symptom onset) anticoagulation with heparin - bolus IV injection of 5000-10000 units followed by continuous infusion at a rate adjusted to prolong the prothrombin time 1.5 to 2.5 times the pretreatment level, and continued for 14 days
    If long-term anticoagulation with coumadin was planned, it was started at least 48 hours after heparin therapy in the immediate group, and on the 10th day in the delayed group. Prothrombin levles were monitored daily.
    100% followed for 14 days

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    recurrent embolism 14 days 2
    (9.52%)    		 0
    (0.00%)    		 100%
    (% to %)    		 9.52%
    (-3.03% to 22.1%)    		 11
    (NNT = 5 to infinity;
    NNH = 33 to infinity)
    haemorrhagic infarction 14 days 2
    (9.52%)    		 0
    (0.00%)    		 100%
    (% to %)    		 9.52%
    (-3.03% to 22.1%)    		 11
    (NNT = 5 to infinity;
    NNH = 33 to infinity)
    death 14 days 2
    (9.52%)    		 0
    (0.00%)    		 100%
    (% to %)    		 9.52%
    (-3.03% to 22.1%)    		 11
    (NNT = 5 to infinity;
    NNH = 33 to infinity)

    Comments

    1. There were no clear differences in baseline characteristics between the two groups.
    2. The trial was too small to show any clear difference in recurrent embolism, haemorrhagic infarction or death, between the two groups.

    Citation

    1. Cerebral Embolism Study Group , : Immediate anticoagulation of embolic stroke: A randomised trial. Stroke 1983; 14 (5): 668-676
    Contributor: Clare Wotton and Musab Hayatli, December 1999
    Reviewer:

    Clinical Question.
    Patient embolic stroke
    Intervention or Exposure immediate anticoagulation
    Comparison delayed anticoagulation
    Outcome recurrent embolism