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Aneurysmal Subarachnoid HaemorrhagePiSAHNCT01832389

Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage

A study testing PiCCO in people with Aneurysmal Subarachnoid Haemorrhage and SAH, run by Technical University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Aneurysmal Subarachnoid Haemorrhage, SAH
What is being tested?
PiCCO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteGermany
Study dates
Mar 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    München, 81675

Other trials in Germany

About this study

Official title: Does a PiCCO-controlled Advanced Haemodynamic Monitoring Improve the Outcome After Aneurysmal Subarachnoid Haemorrhage?

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.

Read the 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).

Being tested
PiCCO
Keywords
Subarachnoid Haemorrhage (SAH), vasospasm, delayed cerebral ischaemia (DCI), goal directed therapy (GDT), Pulse Contour Cardiac Output (PiCCO)
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PiCCODevice

Study groups in NCT01832389
Study groupRoleWhat they receive
Group PActive comparatorPiCCO-controlled group
Receives: Device: PiCCO
Group CNo interventioncontrol group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 days

Secondary outcomes (7)

  1. pulmonary and cardiovascular complications

    Measured: 3 months

  2. neurological complications

    Measured: 3 months

  3. renal and hepatic complications

    Measured: 3 months

  4. electrolyte and serum glucose disturbance

    Measured: 3 months

  5. sepsis, and mortality

    Measured: 3 months

  6. length of hospital and intensive care unit stay

    Measured: 3 months

  7. amount of volume and catecholamines administered

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionNov 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01832389
Sponsor's protocol ID
PiSAH
Acronym
PiSAH
Status last verified
Mar 2019
First submitted
29 Oct 2012
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16436770

  • 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.

    PubMed 35357219

  • 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.

    PubMed 32640940

Questions about this trial

What is this clinical trial studying?

A study testing PiCCO in people with Aneurysmal Subarachnoid Haemorrhage and SAH, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of occurred delayed cerebral ischaemia (DCI) per patient (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01832389, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.

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