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Table 3 Reasons for non-eligibility for the trial

From: Slow recruitment in the HIMALAIA study: lessons for future clinical trials in patients with delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage based on feasibility data

 

Number of patients

n = 383

Reasons for non-eligibility (%)

Contraindication for participation

367 (96%)

 Moribund on admission

160 (44%)a

 No aneurysm found

67 (18%)

 Aneurysm could not (entirely) be treated

47 (13%)

  Partial coiling

9

  Delayed aneurysm treatment due to severe vasospasm

11

  Aneurysm treatment technically not possible

27

 Signs of DCI on admission

23 (6%)

 Cardiac contraindication for iHT

18 (5%)

 Transfer to another hospital

17 (5%)

 Contraindication for CT-contrast agent

10 (3%)

 Noncardiac contraindication for iHT

7 (2%)

 No Dutch or English

6 (2%)

 Legally incompetent patient without a legal representative present

5 (1%)

 DCI immediately after treatment of the aneurysm

3 (1%)

 Admission after DCI risk periodb

1 (0.3%)

 Pregnancy

1 (0.3%)

 Treatment restriction requested by family

1 (0.3%)

 Initially not recognized aSAH

1 (0.3%)

Incorrectly deemed not eligible

16 (4%)

 Delayed admission to the hospital without any signs of DCI yet

5 (31%)

 Not asked for informed consent due to misinterpretation of the in- and exclusion criteria for eligibility while they were actually eligible

11 (69%)

  1. aThree patients eventually did not die during admission. bAdmission after the risk period for DCI had already passed, defined as admission after 14 days after the initial hemorrhage. DCI Delayed cerebral ischemia, iHT Induced hypertension, aSAH Aneurysmal subarachnoid hemorrhage