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InfarctionNCT04865757

Space Flap for Cerebral Protection Following Decompressive Hemicraniectomy for Stroke

A study testing Space Flap in people with Infarction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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

In this study the investigators want to investigate to what extent the application of an artificial bone flape (space flap) influences the success of a decompressive craniectomy. In all participants, a space flap is placed immediately after removal of the skull cap. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Infarction
What is being tested?
Space Flap
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSwitzerland
Study dates
Jul 2012to Sep 2020
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 65 years
  • Decompressive hemi-craniectomy planed for*:
  • Impairment of consciousness or progressive reduction of consciousness and
  • Mass effect on brain imaging (oedema exceeding 50% of the MCA territory and midline shift), and
  • Exclusion of other causes of impaired consciousness (e.g. hypoperfusion, hypotension, cerebral reinfarction, epileptic seizures
  • Informed consent from relatives

Who cannot join

  • Bilateral, nonreactive, not drug-induced pupillary dilation, associated with coma*
  • Simultaneous presence of all four of the following unfavorable prognostic factors: *
  • Age 50 years
  • Involvement of additional vascular territories
  • Unilateral pupillary dilation
  • GCS<8
Show all 12Show fewer
  • Severe comorbidity (severe heart failure or myocardial infarction, incurable neoplasia, etc. *
  • Refusal by the patient of this treatment, as known from current interaction with the patient, from existing written documents or related by the patient's proxies. *
  • Known pulmonary or cranial infection
  • Any coagulopathy
  • Rapid neurological decline prohibiting the extra time needed for space flab production (10min)
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Dep. of Neurosurgery, Bern University Hospital

    Bern, 3010

Other trials in Switzerland

About this study

In this study the investigators want to investigate to what extent the application of an artificial bone flape (space flap) influences the success of a decompressive craniectomy.

In all participants, a space flap is placed immediately after removal of the skull cap. In a second operation, after 1-3 months, an operation is performed, in which the stored own skull bone is re-inserted. The artificial bone cover is removed at this point.

Read the detailed description

The destruction of local brain parenchyma after cerebral infarction leads to local swelling within a few days. In the beginning the ischemic brain expand at the expense of the CSF and venous spaces. However, once these spaces are partially displaced further swelling invariably leads to increase of the intracranial pressure due to the limited space available inside the cranial vault. In cases of large infarctions this increase in intracranial pressure (ICP) may entail life threatening secondary injuries to the brain. The surgical removal of a large part of the skull (decompressive hemi-craniectomy) allows the ischemic brain to expand, therefore avoiding an increase of ICP and it's deleterious effects. After removal of a part of the skull the skin is closed again, and the skull flap is kept in sterile environment. Several months after decompression craniectomy patients undergo implantation of either their preserved bone flap or of a bone flap substitute (so-called patient specific implant, or PSI, mostly made out of Palacos®).

Decompressive hemi-craniectomy comes at a cost for the patient, despite its undisputed role as a life saving surgery after large cerebral infarction. During the first days after surgery the brain may use the space freed up by bone removal. In some cases the brain may prolapse even further out of the cranial vault, leading to brain herniation. Brain herniation are common and may lead to further damage due to axonal shearing injuries in the brain, and to hemorrhages and infarction at the craniotomy edges. The lack of the protective skull prior to re-implantation of the bone flap puts the brain at risk of injuries due to falls during rehabilitation and exposes the brain indirectly to atmospheric pressure. Various neurological deficits subsumed as the syndrome of the trephined have been described in these patients. The symptoms of the syndrome of the trephined have in common that they appear a few weeks after decompression and significantly improve after re-implantation of the patient's own bone. The symptoms range from orthostatic headache and dizziness to motor paresis, aphasia, cognitive decline and brainstem compression symptoms. The pathophysiology behind the syndrome of the trephined can be understood as an "open box" phenomenon. After removal of the bone the brain is separated from the atmospheric pressure only by the skin. The skin, however, does not hold against atmospheric pressure and sinks into the skull cavity (sinking skin flap) once the brain swelling diminishes. Physiologic dynamics of the cerebrospinal fluid are deranged, leading to hydrocephalus, subdural hygromas and parenchymal effusions. This assumption is enforced by pathophysiological observations of decreased cerebral blood flow in both hemispheres following decompression, and normalization thereof following re-implantation of the bone flap.

This pilot study aims at assessing feasibility of a change in surgical protocol. The rate of ICP control will be used to determine the sample size of a planned monocenter study.

Conditions
Infarction
Being tested
Space Flap
Keywords
Decompressive hemi-craniectomy, bone flap
Medical subject headings
Infarction

What participants receive

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

  • Space FlapDevice

    A space flap is formed out of Palacos®, adjusted to the skull surface with temporal augmentation

Study groups in NCT04865757
Study groupRoleWhat they receive
Space FlapExperimentalA space flap is formed out of Palacos®, adjusted to the skull surface with temporal augmentation
Receives: Device: Space Flap

What is being measured

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

  1. ICP Control

    ICP Control (number of hours with mean ICP equal to or > 20mmHg)

    Measured: 1 day after surgery

Secondary outcomes (8)

  1. Intracranial infections

    Intracranial infections (proven by microbiology)

    Measured: 1 day after surgery

  2. Postoperative hematomas

    Postoperative hematomas localized at the edge of the craniotomy

    Measured: 1 day after surgery

  3. Postoperative infarctions

    Postoperative infarctions localized at the edge of the craniotomy

    Measured: 1 day after surgery

  4. Brain herniation

    Brain herniation (>1.5cm out of cranial vault)

    Measured: 1 day after surgery

  5. Syndrom of the trephined

    Syndrom of the trephined assessed by MRI/CT Scan

    Measured: 1 day after surgery

  6. Hydrocephalus malresorptivus

    Hydrocephalus malresorptivus assessed by MRI/CT Scan

    Measured: 1 month after surgery

  7. Adhesions between the brain and the skin

    Adhesions between the brain and the skin

    Measured: 1 month after surgery

  8. Adhesions between the palacos and the temporal muscle

    Adhesions between the palacos and the temporal muscle

    Measured: 1 month after surgery

Timeline

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

  1. First posted29 Apr 2021
  2. Study startJul 2012
  3. Primary completionAug 2020
  4. Study completionSep 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04865757
Sponsor's protocol ID
080/12
Status last verified
Apr 2021
First submitted
22 Apr 2021
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Langfitt TW. Increased intracranial pressure. Clin Neurosurg. 1969;16:436-71. doi: 10.1093/neurosurgery/16.cn_suppl_1.436. No abstract available.

    PubMed 4981573

  • Steiger HJ. Outcome of acute supratentorial cerebral infarction in patients under 60. Development of a prognostic grading system. Acta Neurochir (Wien). 1991;111(3-4):73-9. doi: 10.1007/BF01400491.

    PubMed 1950691

  • Wirtz CR, Steiner T, Aschoff A, Schwab S, Schnippering H, Steiner HH, Hacke W, Kunze S. Hemicraniectomy with dural augmentation in medically uncontrollable hemispheric infarction. Neurosurg Focus. 1997 May 15;2(5):E3; discussion 1 p following E3. doi: 10.3171/foc.1997.2.5.7.

    PubMed 15096004

  • Doerfler A, Engelhorn T, Forsting M. Decompressive craniectomy for early therapy and secondary prevention of cerebral infarction. Stroke. 2001 Mar;32(3):813-5. doi: 10.1161/01.str.32.3.813. No abstract available.

    PubMed 11239209

  • Juttler E, Schwab S, Schmiedek P, Unterberg A, Hennerici M, Woitzik J, Witte S, Jenetzky E, Hacke W; DESTINY Study Group. Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): a randomized, controlled trial. Stroke. 2007 Sep;38(9):2518-25. doi: 10.1161/STROKEAHA.107.485649. Epub 2007 Aug 9.

    PubMed 17690310

  • Hofmeijer J, Kappelle LJ, Algra A, Amelink GJ, van Gijn J, van der Worp HB; HAMLET investigators. Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial. Lancet Neurol. 2009 Apr;8(4):326-33. doi: 10.1016/S1474-4422(09)70047-X. Epub 2009 Mar 5.

    PubMed 19269254

  • Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard JP, Boutron C, Couvreur G, Rouanet F, Touze E, Guillon B, Carpentier A, Yelnik A, George B, Payen D, Bousser MG; DECIMAL Investigators. Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial). Stroke. 2007 Sep;38(9):2506-17. doi: 10.1161/STROKEAHA.107.485235. Epub 2007 Aug 9.

    PubMed 17690311

  • Sanus GZ, Tanriverdi T, Ulu MO, Kafadar AM, Tanriover N, Ozlen F. Use of Cortoss as an alternative material in calvarial defects: the first clinical results in cranioplasty. J Craniofac Surg. 2008 Jan;19(1):88-95. doi: 10.1097/scs.0b013e31815c93fe.

    PubMed 18216670

  • Wagner S, Schnippering H, Aschoff A, Koziol JA, Schwab S, Steiner T. Suboptimum hemicraniectomy as a cause of additional cerebral lesions in patients with malignant infarction of the middle cerebral artery. J Neurosurg. 2001 May;94(5):693-6. doi: 10.3171/jns.2001.94.5.0693.

    PubMed 11354398

  • Honeybul S, Ho KM. Long-term complications of decompressive craniectomy for head injury. J Neurotrauma. 2011 Jun;28(6):929-35. doi: 10.1089/neu.2010.1612. Epub 2011 Jun 1.

    PubMed 21091342

  • Aarabi B, Hesdorffer DC, Ahn ES, Aresco C, Scalea TM, Eisenberg HM. Outcome following decompressive craniectomy for malignant swelling due to severe head injury. J Neurosurg. 2006 Apr;104(4):469-79. doi: 10.3171/jns.2006.104.4.469.

    PubMed 16619648

  • Sakamoto S, Eguchi K, Kiura Y, Arita K, Kurisu K. CT perfusion imaging in the syndrome of the sinking skin flap before and after cranioplasty. Clin Neurol Neurosurg. 2006 Sep;108(6):583-5. doi: 10.1016/j.clineuro.2005.03.012.

    PubMed 15921849

  • Dujovny M, Fernandez P, Alperin N, Betz W, Misra M, Mafee M. Post-cranioplasty cerebrospinal fluid hydrodynamic changes: magnetic resonance imaging quantitative analysis. Neurol Res. 1997 Jun;19(3):311-6. doi: 10.1080/01616412.1997.11740818.

    PubMed 9192385

  • Stiver SI, Wintermark M, Manley GT. Reversible monoparesis following decompressive hemicraniectomy for traumatic brain injury. J Neurosurg. 2008 Aug;109(2):245-54. doi: 10.3171/JNS/2008/109/8/0245.

    PubMed 18671636

  • Mokri B. Orthostatic headaches in the syndrome of the trephined: resolution following cranioplasty. Headache. 2010 Jul;50(7):1206-11. doi: 10.1111/j.1526-4610.2010.01715.x. Epub 2010 Jun 18.

    PubMed 20561067

Questions about this trial

What is this clinical trial studying?

A study testing Space Flap in people with Infarction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 6 inclusion and 12 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 29 Apr 2021. 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 Switzerland. 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?

ICP Control (time frame: 1 day after surgery). 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 NCT04865757, which also lists 22 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 29 Apr 2021.

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