MEASURE

The Multicenter Registry of Patients with Subarachnoid Hemorrhage (MEASURE) is a longitudinal, observational registry that will prospectively enroll patients from all Dutch SAH treatment centers. Patients with aneurysmal subarachnoid hemorrhage (SAH), perimesencephalic SAH, angio-negative SAH and SAH caused by other vascular malformations will be included in the registry. MEASURE is part of the ‘Collaboration for New TReatments of Acute Stroke 2.0’ (CONTRAST 2.0) consortium.

Kind regards,

On behalf of the MEASURE executive committee and the CONTRAST consortium,
Professor H.D. (Jeroen) Boogaarts, MD PhD (neurosurgeon, Radboud University Medical Center, Principal Investigator)
Professor G.J.E. (Gabriël) Rinkel, MD PhD (neurologist, University Medical Center Utrecht, Principal Investigator)
Professor D. (Dagmar) Verbaan, PhD (clinical epidemiologist, Amsterdam University Medical Center, Principal investigator)
M.D.I. (Mervyn) Vergouwen, MD PhD (neurologist, University Medical Center Utrecht, Principal Investigator)
P.B. (Philippine) van Wijngaarden, MD (PhD candidate, University Medical Center Utrecht, Coordinating Investigator)

Rationale and aim

One of the most important determinants of poor outcome after aSAH is rebleeding of the aneurysm. The risk of rebleeding can be diminished or, ideally, obviated by endovascular or neurosurgical treatment of the aneurysm. For decades, neurosurgical clipping was the standard treatment for a ruptured aneurysm. After publication of the ISAT trial, endovascular coiling became the preferred method, if both clipping and coiling were eligible. Additionally, over the last decade advanced endovascular treatment options were introduced, such as balloon- or stent-assisted coiling, flow diverting stents, and intrasaccular devices. Despite these advances and benefits of new endovascular techniques and materials, procedures might also have higher complication rates compared to standard coiling.

Several (mostly single-centre) SAH registries in the world have increased our knowledge on SAH-disease-specific complications (such as rebleeding, delayed cerebral ischemia, hydrocephalus) and long-term outcomes. Registries usually focused on the prevention and treatment of these disease-specific complications and functional or cognitive outcomes, however, they did not capture data on this novel endovascular armamentarium. And notably, regulatory and re-imbursement bodies are increasingly seeking for real-world data on implementation and follow-up of new endovascular devices and techniques.

The MEASURE registry will gather highly detailed data on patients with subarachnoid hemorrhage in current clinical practice in the Netherlands and use this data to answer key clinical questions.

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.

Study protocol and documents

Registry protocol

SOP MEASURE

Zakkaartje

Zakkaartje MEASURE

PIF

• Amsterdam UMC
  • PIF ‘MEASURE Registry patient’ AUMC
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ AUMC
  • PIF ‘MEASURE Registry patient tweede instantie’ AUMC
• Elisabeth Tweesteden Ziekenhuis
  • PIF ‘MEASURE Registry patient’ ETZ
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ ETZ
  • PIF ‘MEASURE Registry patient tweede instantie’ ETZ
• Erasmus Medisch Centrum
  • PIF ‘MEASURE Registry patient’ EMC
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ EMC
  • PIF ‘MEASURE Registry patient tweede instantie’ EMC
• Haagland Medisch Centrum
  • PIF ‘MEASURE Registry patient’ HMC
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ HMC
  • PIF ‘MEASURE Registry patient tweede instantie’ HMC
• Isala
  • PIF ‘MEASURE Registry patient’ ISALA
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ ISALA
  • PIF ‘MEASURE Registry patient tweede instantie’ ISALA
• Maastricht UMC
  • PIF ‘MEASURE Registry patient’ MUMC
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ MUMC
  • PIF ‘MEASURE Registry patient tweede instantie’ MUMC
• Radboudumc
  • PIF ‘MEASURE Registry patient’ Radboud UMC
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ Radboud UMC
  • PIF ‘MEASURE Registry patient tweede instantie’ radboud UMC
• UMC Groningen
  • PIF ‘MEASURE Registry patient’ UMCG
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ UMCG
  • PIF ‘MEASURE Registry patient tweede instantie’ UMCG
  • PIF ‘MEASURE Registry nabestaande’ UMCG
• UMC Utrecht
  • PIF ‘MEASURE Registry patient’ UMCU
  • PIF ‘MEASURE Registry wettelijke vertegenwoordiger’ UMCU
  • PIF ‘MEASURE Registry patient tweede instantie’ UMCU

Intervention CRFs

Neurosurgical aneurysm treatment

Endovascular aneurysm treatment

Organization

Principle investigators

Professor H.D. (Jeroen) Boogaarts, MD PhD (neurosurgeon, Radboud University Medical Center, Principal Investigator)
Professor G.J.E. (Gabriël) Rinkel, MD PhD (neurologist, University Medical Center Utrecht, Principal Investigator)
Professor D. (Dagmar) Verbaan, PhD (clinical epidemiologist, Amsterdam University Medical Center, Principal investigator)
M.D.I. (Mervyn) Vergouwen, MD PhD (neurologist, University Medical Center Utrecht, Principal Investigator)

Coordinating investigator

P.B. (Philippine) van Wijngaarden, MD (PhD candidate, University Medical Center Utrecht, Coordinating Investigator)

Participating centers

• Amsterdam UMC
  • Location: Amsterdam
  • Local investigator(s): D. Verbaan, B.J. Emmer
  • Research assistant
• Elisabeth Tweesteden Ziekenhuis
  • Location: Tilburg
  • Local investigator(s): P.J.P. Nachtergaele, B. van der Pol, H.G.J. Kortman, J. Manuputty
  • Research assistant
• Erasmus Medisch Centrum
  • Location: Rotterdam
  • Local investigator(s): V. Volovici, P.J. van Doormaal, R. Dammers, B. Roozenbeek
  • Research assistant
• Haagland Medisch Centrum
  • Location: Den Haag/Leiden
  • Local investigator(s): W.A. Moojen, I.R. van den Wijngaard
  • Research assistant
• Isala
  • Location: Zwolle
  • Local investigator(s): M. Foumani, M.H. den Hertog, F.H. Potters
  • Research assistant
• Maastricht UMC
  • Location: Maastricht]
  • Local investigator(s): I.R. de Ridder, R.H.L. Haeren, W.H. van Zwam
  • Research assistant
• Radboudumc
  • Location: Nijmegen
  • Local investigator(s): H.D. Boogaarts
  • Research assistant
• UMC Groningen
  • Location: Groningen
  • Local investigator(s): J.M.C. van Dijk, M. Uyttenboogaart
  • Research assistant
• UMC Utrecht
  • Location: Utrecht
  • Local investigator(s): M.D.I. Vergouwen, A. van der Zwan, I.C. van der Schaaf
  • Research assistant.

Contact

University Medical Center Utrecht, Trial Bureau Neurology
MEASURE researchers
D.03.242
Postbus 85500
3508 GA Utrecht
Email: measure@umcutrecht.nl
088-75 55 55 5

Study progress

MEASURE include patient

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