Trial document




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  DRKS00000328

Trial Description

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Title

Prospective randomised multi-centre trial (Phase III) on the improvement of cochlear and facial nerve functions after vestibular schwannoma surgery by prophylactic vasoactive treatment.

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Trial Acronym

AkNiPro

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Facial nerve paresis and hearing loss are common complications after vestibular schwannoma surgery. The purpose of this clinical research study is to see if adding a prophylactic treatment consisting of nimodipine and hydroxyethylstarch one day prior until seven days after the surgery may help to reduce the complications named above. This treatment has not yet been established in clinical routine, however, preceding studies showed promising results on patients receiving prophylactic treatment. To confirm the positive effect on the preservation of facial and hearing nerve functions on a higher number of patients the present study was initiated. In the future, vasoactive treatment may be recommended as a routine therapy.

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Brief Summary in Scientific Language

Depending on the size of the tumor and the preoperative function of the facial and vestibular nerves, facial nerve paresis and hearing loss are common complications after vestibular schwannoma surgery. A Pilot-study with 30 patients (Neurosurgery, 2007 Jul;61(1):92-7; discussion 97-8) showed a beneficial effect of prophylactic treatment consisting of nimopidine and hydroxyethylstarch on preservation of facial and cochlear nerve functions in vestibular schwannoma surgery. To confirm these results as well as to increase the scientific power a prospective, randomised clinical trial (Phase III) with a higher number of patients is needed.

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Organizational Data

  •   DRKS00000328
  •   2010/02/17
  •   [---]*
  •   yes
  •   Approved
  •   AkNiPro, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

  •   U1111-1113-5499 
  •   2009-012088-32 
  •   4035768 
  •   KKSH-066  (Martin-Luther-Universität Halle-Wittenberg)
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Health Condition or Problem studied

  •   LLT 10000522: Acoustic neurinoma
  •   D33.3 -  Benign neoplasm: Cranial nerves
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Interventions/Observational Groups

  •   Surgery plus prophylactic vasoactive treatment consisting of nimodipine (Nimotop® S 5-10 ml/h (1-2 mg/h) i.v.) and hydroxyethylstarch (Voluven® 6%, aim at a hematocrit 30-35%, max. 2 x 500 ml/d, i.v.) which start the day before surgery and to be continued until the seventh postoperative day
  •   Surgery without prophylactic vasoactive treatment. When intra-operative monitoring show signs of a deterioration of facial or cochlear nerve function, vasoactive treatment consisting of nimodipine (Nimotop® S 5-10 ml/h (1-2 mg/h) i.v.) and hydroxyethylstarch (Voluven® 6%, aim at a hematocrit 30-35%, max. 2 x 500 ml/d, i.v.) will be started immediately. Vasoactive treatment will then be continued until the seventh postoperative day.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

Binary outcome value. Deterioration of facial nerve functions 12 month after surgery for at least 1 grade (House-Brackmann classification)

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Secondary Outcome

Facial nerve functions once during the first 7 days postoperatively as well as 3, 6 and 12 month after surgery compared to the preoperative situation determined using the House-Brackmann classification. || Cochlear nerve functions once during the first 7 days postoperatively and 12 month after surgery determined using the following classifications
a)"Committee on Hearing and Equilibrium guidelines for the evaluation of hearing preservation in acoustic neuroma (vestibular schwannoma)"
b) Grading of hearing loss according Gardener and Robertson

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/01/27
  •   112
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age >= 18 years
- Male or female patients who are able to give informed consent
- Acoustic neuroma, indication for surgery
- Written informed consent

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Exclusion Criteria

- Contraindication for the administration of study drug (nimodipine, hydroxyethylstarch)
- Concurrent treatment with other experimental drugs or
participation in another clinical trial with any investigational drug within 30 days prior to study screening
- History of critical interactions between nimodipine and other potentially nephrotoxic agents such as aminoglycosids, cephalosporids, furosemid
- Preoperative facial nerve function House-Brackmann grade VI
- Preliminary surgery of the acoustic neuroma
- Pregnancy and lactation
- Incompliance
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening
- Other reasons for inability to undergo surgery
- Neurofibrimatosis type 2

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Addresses

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    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät
    • Magdeburger Str. 8
    • 06112  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale) Klinik und Poliklinik für Neurochirurgie
    • Mr.  Dr. med.  Christian  Scheller 
    • Ernst-Grube-Straße 40
    • 06097  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale) Klinik und Poliklinik für Neurochirurgie
    • Mr.  Dr. med.  Christian  Scheller 
    • Ernst-Grube-Straße 40
    • 06097  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Prodekanat Forschung
    • Magdeburger Straße 8
    • 06097  Halle (Saale)
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/26
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Trial Publications, Results and other Documents

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