Study design

Design

MEASURE is a longitudinal, observational registry that will prospectively enroll patients from all Dutch SAH treatment centers.

Population

All consecutive patients with SAH who are admitted in one of the Dutch SAH treatment centers. Patients with aneurysmal SAH, perimesencephalic SAH, angio-negative SAH and SAH caused by other vascular malformations will be included in the registry.

In- and exclusion criteria

To be eligible to participate in this registry, a subject must meet all the following criteria

  • Spontaneous SAH in one or more basal cisterns or fissures, proven by non-contrast head CT or lumbar puncture, irrespective of the cause (including aneurysmal SAH, SAH caused by another vascular malformation, angio-negative SAH, perimesencephalic hemorrhage)
  • Written informed consent in non-deceased patients

A potential subject who meets the following criterium will be excluded from participation in this registry

  • Traumatic SAH
  • Non-traumatic convexity SAH (for example caused by cerebral amyloid angiopathy, reversible cerebral vasoconstriction syndrome, or cerebral venous sinus thrombosis)
  • Patients under the age of 18 years

Main study parameters

The modified Ranking Scale (mRS) score after 6 months ± 30 days after aSAH.

Secondary study parameters

  • Complications related to the treatment of the ruptured aneurysm
  • Complications related to SAH
  • mRS after 18 months ± 30 days after aSAH
  • Degree of aneurysm occlusion. For endovascular treatment according to the (modified) Raymond Roy classification at 6 and 18 months ± 30 days after aSAH. For neurosurgical treatment the percentage of occlusion, moment according to local treatment protocol.
  • Newly found aneurysm at additional imaging (in patients with primary angionegative SAH)
  • Patient reported outcomes up to 18 months (± 30 days) using online/postal questionnaires or a telephone interview
  • Costs up to 18 months (± 30 days) using online/postal questionnaires or a telephone interview

Informed consent

Patients admitted in one of the tertiary SAH referral centers will be informed about the registry and asked for consent. This will be done by either a research nurse, investigator or treating physician. Patients or their legal representative are given as much time as they need to consider their decision before filling in the consent. The patient information letter and broad consent form is attached as a separate document. If no informed consent can be obtained from the patients because of incompetence at the time, i.e., by the effect of the SAH, consent will be obtained from the legal representative. If during the admission period no legal representative is available, obtaining consent will be postponed until the legal representative is available, or the patient becomes competent. As soon as the legal representative is available, or the patient becomes competent, the consent procedure will be attempted. If the legal representative previously has given consent and the patient becomes competent, new informed consent will be obtained from the patient. If the patient refuses consent, acquisition of data will cease, and data acquired up until then will be used for analysis. If the patient wishes, the up until then acquired data will be destroyed. If a patient dies before formal consent was given, available data will be included in the registry.