Admission HbA1C in Aneurysmal Subarachnoid Hemorrhage

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Heinrich-Heine University, Duesseldorf
Sponsor:
Information provided by (Responsible Party):
Neurochirurgische Klinik, Universitätsklinikum Düsseldorf, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT02081820
First received: February 28, 2014
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition
Hyperglycemia
Aneurysmal Subarachnoid Hemorrhage

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Observational Study on the Prognostic Relevance of Admission Glycated Hemoglobin (HbA1C) in Patients With Aneurysmal Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • modified Rankin score [ Time Frame: 6 month after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of DCI related new infarction on discharge ct scan [ Time Frame: at discharge, approx. 14-21days after admission ] [ Designated as safety issue: No ]
    Incidence of new infarction on discharge ct scan not attributable to causes other then DCI.


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
aneurysmal subarachnoid hemorrhage
observational, no intervention

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081820

Contacts
Contact: Kerim Beseoglu, M.D. 0049-211-81- ext 19727 beseoglu@med.uni-duesseldorf.de

Locations
Germany
Department of Neurosurgery, Heinrich-Heine-University Düsseldorf Recruiting
Düsseldorf, NRW, Germany, 40225
Contact: Kerim Beseoglu, M.D.    0049-211-81 ext 19727    beseoglu@med.uni-duesseldorf.de   
Principal Investigator: Kerim Beseoglu, M.D.         
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Kerim Beseoglu, M.D. Department of Neurosurgery, Heinrich-Heine-University, Düsseldorf
  More Information

Additional Information:
No publications provided

Responsible Party: Neurochirurgische Klinik, Universitätsklinikum Düsseldorf, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02081820     History of Changes
Other Study ID Numbers: UKD-NCH-2014-001
Study First Received: February 28, 2014
Last Updated: March 5, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:
hyperglycemia
aneurysmal subarachnoid hemorrhage
glycated hemoglobin
outcome
DCI

Additional relevant MeSH terms:
Hyperglycemia
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014