NCT01832389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

October 29, 2012

Last Update Submit

March 11, 2019

Conditions

Aneurysmal Subarachnoid HaemorrhageSAH

Keywords

Subarachnoid Haemorrhage (SAH)vasospasmdelayed cerebral ischaemia (DCI)goal directed therapy (GDT)Pulse Contour Cardiac Output (PiCCO)

Outcome Measures

Primary Outcomes (1)

  • number of occurred delayed cerebral ischaemia (DCI) per patient

    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.

    14 days

Secondary Outcomes (7)

  • pulmonary and cardiovascular complications

    3 months

  • neurological complications

    3 months

  • renal and hepatic complications

    3 months

  • electrolyte and serum glucose disturbance

    3 months

  • sepsis, and mortality

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Group P

ACTIVE COMPARATOR

PiCCO-controlled group

Device: PiCCO

Group C

NO INTERVENTION

control group

Interventions

PiCCODEVICE
Group P

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • traumatic SAH
  • congestive heart failure
  • severe diseases of aorta or aortic valve
  • pregnancy
  • calcium antagonist intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

München, 81675, Germany

Location

Related Publications (3)

  • Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006 Jan 26;354(4):387-96. doi: 10.1056/NEJMra052732. No abstract available.

    PMID: 16436770BACKGROUND

  • Althouse AD, Jain SK, Shalaby A, Singh M, Weiss R, Myaskovsky L, Al-Khatib SM, Saba S. Feasibility of a Randomized Clinical Trial of Cardiac Resynchronization Therapy With or Without an Implantable Defibrillator in Older Patients. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010795. doi: 10.1161/CIRCEP.121.010795. Epub 2022 Mar 31. No abstract available.

    PMID: 35357219DERIVED

  • Anetsberger A, Gempt J, Blobner M, Ringel F, Bogdanski R, Heim M, Schneider G, Meyer B, Schmid S, Ryang YM, Wostrack M, Schneider J, Martin J, Ehrhardt M, Jungwirth B. Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial. Stroke. 2020 Aug;51(8):2287-2296. doi: 10.1161/STROKEAHA.120.029279. Epub 2020 Jul 9.

    PMID: 32640940DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

April 16, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2015

Study Completion

December 1, 2016

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

DE(1)