Clinical trial NCT02081820: Admission HbA1C in Aneurysmal Subarachnoid Hemorrhage
Official title: Observational Study on the Prognostic Relevance of Admission Glycated Hemoglobin (HbA1C) in Patients With Aneurysmal Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Aneurysmal Subarachnoid Hemorrhage
Keywords: hyperglycemia
aneurysmal subarachnoid hemorrhage
glycated hemoglobin
outcome
DCI
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with confirmed aneurysmal subarachnoid hemorrhage admitted within 72 hours to our department aged over 18 years.

Brief summary: In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission after aSAH serves as an approximation of blood glucose levels in the weeks preceding aneurysm rupture. In this patient registry admission HbA1c, clinical course and neurological outcome after 6 month are recorded, to determine whether elevated blood glucose levels prior to aneurysm rupture influence the clinical course and patient outcome after aSAH.

Detailed description: In patients suffering from aneurysmal subarachnoid hemorrhage (aSAH), hyperglycemia is considered an adverse prognostic factor. Glycated hemoglobin (or HbA1c) can be measured to estimate the average plasma glucose concentration over prolonged periods of time, thus determination of glycated hemoglobin at admission after aSAH serves as an approximation of blood glucose levels in the weeks preceding aneurysm rupture.

In this patient registry admission HbA1c within 72 hours after confirmed aneurysmal subarachnoid hemorrhage in patients aged over 18 years is determined and correlated with clinical course and neurological outcome after 6 month as determined by modified Rankin score. Additionally, patients are monitored for incidence of delayed cerebral ischemia (DCI) and the incidence of new infarction on the discharge ct scan attributable to DCI. General treatment of cerebral aneurysm and subarachnoid hemorrhage in all patients follows international guidelines.

Eligibility criteria: Inclusion Criteria:

* confirmed aneurysmal subarachnoid hemorrhage
* admission within 72hours after hemorrhage
* Age \>18 years

Exclusion Criteria:

* non-aneurysmal SAH
* admission \>72hours after hemorrhage
* Age \<18 years

Primary outcomes:
measure: modified Rankin score
timeFrame: 6 month after discharge
Secondary outcomes:
measure: Incidence of DCI related new infarction on discharge ct scan
timeFrame: at discharge, approx. 14-21days after admission
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of Neurosurgery, Heinrich-Heine-University Düsseldorf
state: NRW
Study officials:
affiliation: Department of Neurosurgery, Heinrich-Heine-University, Düsseldorf
name: Kerim Beseoglu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: