Trial document





This trial has been registered retrospectively.
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  DRKS00012603

Trial Description

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Title

Hypervolemic treatment in acute non-arteriitic aion

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Trial Acronym

HAA

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URL of the Trial

http://-

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Brief Summary in Lay Language

Retrobulbar Perfusionparameters are recorded prior and after infusion of 250 cc HES - solution in NAION patients. HES is used in intesive care units for volume expansion. AION is caused by a disturbed perfusion of the optic nerve leading to subsequent ischaemic infarction. The disease is comparable to apoplexy affecting only the optic nerve.
After infusion of HES-solution an expansion of the blood volume occurs and therefore an increased retrobulbar and intraocular blood flow can be recorded. Improved blood flow might lead to better clinical outcomes in the disease and thereby be a valuable treatment option.

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Brief Summary in Scientific Language

Twenty-four consecutive patients with acute NAION are included in this study. By the use of color Doppler imaging we examine the retrobulbar hemodynamics before and 15 min after infusion of 250 cc 10% hydroxyethyl starch (molecular weight 200.000/ degree of substitution 0.5 within 30 min). Peak-systolic (PSV) and end-diastolic velocities (EDV) and Pourcelot´s resistive index (RI) are measured in the ophthalmic artery (OA), central retinal artery (CRA) and the short posterior ciliary arteries (PCA)

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Organizational Data

  •   DRKS00012603
  •   2017/07/18
  •   [---]*
  •   yes
  •   Approved
  •   123/03, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H47.0 -  Disorders of optic nerve, not elsewhere classified
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Interventions/Observational Groups

  •   250 cc 10% hydroxyethyl starch (molecular weight 200.000), i.v., once. CDI - measurements prior and 15min after infusion of HES
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Perfusionparameters (Peak-systolic (PSV) and end-diastolic velocities (EDV) and Pourcelot´s resistive index (RI) are measured in the ophthalmic artery (OA), central retinal artery (CRA) and the short posterior ciliary arteries (PCA)) measured via Colour Doppler Imaging (CDI) prior and after infusion of HES. An increased blood flow is expected after infusion of HES.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2004/02/20
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Acute non-arteriitic AION

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Exclusion Criteria

arteriitic AION

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik RWTH Aachen
    • Mr.  Prof. Dr. med.  Peter  Walter 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    •   0241-80-88192
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    •   [---]*
    •   [---]*
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    • Uniklinik RWTH Aachen, Augenklinik
    • Mr.  Prof. Dr. med.  Niklas  Plange 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Uniklinik RWTH Aachen, Augenklinik
    • Mr.  Prof. Dr. med.  Niklas  Plange 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik RWTH Aachen, Augenklinik
    • Mr.  Prof. Dr. med.  Peter  Walter 
    • Pauwelsstraße 30
    • 52074  Aachen
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2004/10/15
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.