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Trial record 50 of 198 for:    Hemorrhage AND SAH

Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage (PiSAH)

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ClinicalTrials.gov Identifier: NCT01832389
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Tracking Information
First Submitted Date  ICMJE October 29, 2012
First Posted Date  ICMJE April 16, 2013
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE March 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
number of occurred delayed cerebral ischaemia (DCI) per patient [ Time Frame: 14 days ]
a 2 point increase in the score of the NIHSS-scale lasting for at least 8 hours or a ≥ 2-point decrease in the Glasgow Coma Scale (GCS) lasting for at least 8 hours (as signs of a new focal neurological deficit); and/or radiologic signs of cerebral infarction in presence of vasospasm. other causes of neurological aggravation (e.g. hydrocephalus, re-bleeding etc) had to be excluded.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2013)
number of occurred delayed cerebral ischaemia (DCI) per patient [ Time Frame: 14 days ]
a 2 point increase in the score of the NIHSS-scale lasting for at least 8 hours
Change History Complete list of historical versions of study NCT01832389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2013)
  • pulmonary and cardiovascular complications [ Time Frame: 3 months ]
  • neurological complications [ Time Frame: 3 months ]
  • renal and hepatic complications [ Time Frame: 3 months ]
  • electrolyte and serum glucose disturbance [ Time Frame: 3 months ]
  • sepsis, and mortality [ Time Frame: 3 months ]
  • length of hospital and intensive care unit stay [ Time Frame: 3 months ]
  • amount of volume and catecholamines administered [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage
Official Title  ICMJE Does a PiCCO-controlled Advanced Haemodynamic Monitoring Improve the Outcome After Aneurysmal Subarachnoid Haemorrhage?
Brief Summary The objective of this study is to determine whether a goal-directed therapy can reduce the incidence of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.
Detailed Description

The aneurysmal subarachnoid haemorrhage (SAH) is a frequent and dangerous worldwide cause for stroke. A typical complication presents delayed cerebral ischemia as a consequence of cerebral vasospasms, which occurs in 46% of the cases. The Triple-H-therapy (Hypervolaemia, Hypertension and Haemodilution) was favoured to prevent ischaemic complications after vasospasm for a long time. However recently, the focus is mainly on hypertension, and it is recommended to maintain normovolaemia. The debate how to assure normovolaemia is still on going, therefore, this study was designed to examine whether a PiCCO-controlled haemodynamic monitoring and a goal-directed therapy can reduce the incidence of delayed cerebral ischaemia after SAH.

The present study is a prospective randomized controlled clinical study. Patients older than 18 years with an aneurysmal SAH will be enrolled. They will be divided into two groups: a control group "C" and a PiCCO group "P". Both groups will be treated according to the current guidelines. In addition, in group P the volume and catecholamine therapy will be controlled by means of PiCCO-controlled monitoring and an algorithm.

The primary end point is the number of occurred delayed cerebral ischaemia per patient. Secondary end points are neurological, pulmonary, cardiovascular, renal, and hepatic complications as well as electrolyte and serum glucose disturbance, sepsis, and mortality, length of hospital and intensive care unit stay and the amount of volume and catecholamines administered.

All participants are to be contacted three months after discharge, and their health status is to be determined by using the GOS (Glasgow Outcome Scale).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aneurysmal Subarachnoid Haemorrhage
  • SAH
Intervention  ICMJE Device: PiCCO
Study Arms  ICMJE
  • Active Comparator: Group P
    PiCCO-controlled group
    Intervention: Device: PiCCO
  • No Intervention: Group C
    control group
Publications * Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006 Jan 26;354(4):387-96. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2013)
108
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aneurysmal Subarachnoid Haemorrhage (SAH)
  • Age ≥ 18 years

Exclusion Criteria:

  • traumatic SAH
  • congestive heart failure
  • severe diseases of aorta or aortic valve
  • pregnancy
  • calcium antagonist intolerance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01832389
Other Study ID Numbers  ICMJE PiSAH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Technische Universität München
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bettina Jungwirth, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Principal Investigator: Aida Anetsberger, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
PRS Account Technische Universität München
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP