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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02081820
Other study ID # UKD-NCH-2014-001
Secondary ID
Status Completed
Phase N/A
First received February 28, 2014
Last updated March 17, 2015
Start date July 2012
Est. completion date December 2014

Study information

Verified date March 2015
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Neurosurgery, Heinrich-Heine-University Düsseldorf Düsseldorf NRW

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary modified Rankin score 6 month after discharge No
Secondary Incidence of DCI related new infarction on discharge ct scan Incidence of new infarction on discharge ct scan not attributable to causes other then DCI. at discharge, approx. 14-21days after admission No
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