Space Flap for Cerebral Protection Following Decompressive Hemicraniectomy for Stroke

NCT04865757 | Completed

• 1 other identifier: 080/12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infarction

Keywords

Decompressive hemi-craniectomy; bone flap

Outcome Measures

Primary Outcomes (1)

• ICP Control

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

  1 day after surgery

Secondary Outcomes (8)

• Intracranial infections

  1 day after surgery

• Postoperative hematomas

  1 day after surgery

• Postoperative infarctions

  1 day after surgery

• Brain herniation

  1 day after surgery

• Syndrom of the trephined

  1 day after surgery

Study Arms (1)

Space Flap

EXPERIMENTAL

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

Device: Space Flap

Interventions

Space Flap DEVICE

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

Space Flap

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Informed consent from relatives

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (22)

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

  PMID: 4981573 BACKGROUND

• 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.

  PMID: 1950691 BACKGROUND

• 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.

  PMID: 15096004 BACKGROUND

• 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.

  PMID: 11239209 BACKGROUND

• 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.

  PMID: 17690310 BACKGROUND

• 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.

  PMID: 19269254 BACKGROUND

• 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.

  PMID: 17690311 BACKGROUND

• 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.

  PMID: 18216670 BACKGROUND

• 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.

  PMID: 11354398 BACKGROUND

• 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.

  PMID: 21091342 BACKGROUND

• 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.

  PMID: 16619648 BACKGROUND

• 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.

  PMID: 15921849 BACKGROUND

• 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.

  PMID: 9192385 BACKGROUND

• 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.

  PMID: 18671636 BACKGROUND

• 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.

  PMID: 20561067 BACKGROUND

• Joseph V, Reilly P. Syndrome of the trephined. J Neurosurg. 2009 Oct;111(4):650-2. doi: 10.3171/2009.3.JNS0984.

  PMID: 19361266 BACKGROUND

• Bijlenga P, Zumofen D, Yilmaz H, Creisson E, de Tribolet N. Orthostatic mesodiencephalic dysfunction after decompressive craniectomy. J Neurol Neurosurg Psychiatry. 2007 Apr;78(4):430-3. doi: 10.1136/jnnp.2006.099242. Epub 2006 Nov 21.

  PMID: 17119005 BACKGROUND

• Akins PT, Guppy KH. Sinking skin flaps, paradoxical herniation, and external brain tamponade: a review of decompressive craniectomy management. Neurocrit Care. 2008;9(2):269-76. doi: 10.1007/s12028-007-9033-z.

  PMID: 18064408 BACKGROUND

• Fodstad H, Love JA, Ekstedt J, Friden H, Liliequist B. Effect of cranioplasty on cerebrospinal fluid hydrodynamics in patients with the syndrome of the trephined. Acta Neurochir (Wien). 1984;70(1-2):21-30. doi: 10.1007/BF01406039.

  PMID: 6741628 BACKGROUND

• Yang XF, Wen L, Shen F, Li G, Lou R, Liu WG, Zhan RY. Surgical complications secondary to decompressive craniectomy in patients with a head injury: a series of 108 consecutive cases. Acta Neurochir (Wien). 2008 Dec;150(12):1241-7; discussion 1248. doi: 10.1007/s00701-008-0145-9. Epub 2008 Nov 13.

  PMID: 19005615 BACKGROUND

• Won YD, Yoo DS, Kim KT, Kang SG, Lee SB, Kim DS, Hahn ST, Huh PW, Cho KS, Park CK. Cranioplasty effect on the cerebral hemodynamics and cardiac function. Acta Neurochir Suppl. 2008;102:15-20. doi: 10.1007/978-3-211-85578-2_3.

  PMID: 19388280 BACKGROUND

• Michel P, Arnold M, Hungerbuhler HJ, Muller F, Staedler C, Baumgartner RW, Georgiadis D, Lyrer P, Mattle HP, Sztajzel R, Weder B, Tettenborn B, Nedeltchev K, Engelter S, Weber SA, Basciani R, Fandino J, Fluri F, Stocker R, Keller E, Wasner M, Hanggi M, Gasche Y, Paganoni R, Regli L; Swiss Working Group of Cerebrovascular Diseases with the Swiss Society of Neurosurgery and the Swiss Society of Intensive Care Medicine. Decompressive craniectomy for space occupying hemispheric and cerebellar ischemic strokes: Swiss recommendations. Int J Stroke. 2009 Jun;4(3):218-23. doi: 10.1111/j.1747-4949.2009.00283.x. No abstract available.

  PMID: 19659825 BACKGROUND

MeSH Terms

Conditions

Infarction

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Schucht Philippe, MD

  Dep. of Neurosurgery, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 29, 2021
• Study Start: July 1, 2012
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

CH (1)