Trial document




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  DRKS00011175

Trial Description

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Title

Multicenter, randomized, controlled trial of remote ischemic preconditioning in the surgical management of gliomas

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Trial Acronym

RIP_G

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URL of the Trial

http://-

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Brief Summary in Lay Language

Regarding neurosurgical tumor resections perioperative ischemia (stroke) is a frequent phenomenon and often responsible for postoperative neurological deficits. In particular in the field of cardiac surgery, but also in other fields it has been shown that the application of ischemic stimulus, not only in the target organ, but also elsewhere in the body, can prevent ischemia in some patients. This is described as ischemic preconditioning. In Neurosurgery it has not been sufficiently evaluated. This Study evaluates the effect of ischemic preconditioning on the occurrence of preoperative ischemia in patients with gliomas (intrinsic brain tumors).

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Brief Summary in Scientific Language

Regarding neurosurgical tumor resections perioperative ischemia is a frequent phenomenon and often responsible for postoperative neurological deficits. In particular in the field of cardiac surgery, but also in other fields it has been shown that the application of ischemic stimulus, not only in the target organ, but also elsewhere in the body, can prevent ischemia in some patients. This is described as ischemic preconditioning. In Neurosurgery it has not been sufficiently evaluated. This Study evaluates the effect of ischemic preconditioning on the occurrence of preoperative ischemia in patients with gliomas.
Randomization of by computer in two study arms (ratio 1:1). Induction of ischemic preconditioning: A
blood pressure cuff is attached to the arm (contralateral to the brain tumor) and inflated three times for 5 minutes at 200 mmHg in the treatment group after induction of anesthesia. Between the cycles, the cuff pressure is released to allow reperfusion. In the placebo group, a blood pressure cuff is only attached to the arm. The other anesthetic procedures correspond to the standard procedures for resection of brain tumors. The postoperative MRI will be evaluated for the volume of the postoperative ischemia. Additionally
postoperative neurological status between the two groups will be compared. By exosome and metabolite analysis in a subgroup of patients the effect of ischemic preconditioning will be characterized.

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Organizational Data

  •   DRKS00011175
  •   2016/10/11
  •   [---]*
  •   yes
  •   Approved
  •   339/16 S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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

  •   C71.9 -  Malignant neoplasm: Brain, unspecified
  •   I63.9 -  Cerebral infarction, unspecified
  •   Glioma, brain tumor
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Interventions/Observational Groups

  •   A blood pressure cuff is attached to the arm (contralateral to the brain tumor) and inflated
    three times for 5 minutes at 200 mmHg in the treatment group after induction of anesthesia. Between the cycles, the cuff pressure is released to allow reperfusion.
  •   In the placebo group, a blood pressure cuff is attached to the arm, only.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Volume of ischemia assessed by direct postoperative cMRI (<72h)

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Secondary Outcome

neurological deficits (NIHSS one week postoperative/discharge), clinical status (KPS one week postoperative/discharge), time to tumor progression, overallsurvival, hemodynamic parameters during surgery

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/20
  •   440
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Patients with suspected primary brain tumor for which surgical resection is planned;
Consent to participate in the study;
Age> 18.

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Exclusion Criteria

Non OP-enabled patient (from anesthesiological, medical or surgical view);
Patients who have to be operated immediately without extensive preoperative diagnosis;
Lack of surgical consent;
Lack of consent to participate in the study;
Pregnancy;
Age <18 years;
History of peripheral arterial disease (PAD) or DM with use of oral antidiabetics.

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Addresses

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    • Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar
    • Mr.  PD Dr  Jens  Gempt 
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar
    • Mr.  PD Dr  Jens  Gempt 
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar
    • Mr.  PD Dr  Jens  Gempt 
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar
    • Mr.  PD Dr  Jens  Gempt 
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.