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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00007931
Date of registration:	08/06/2015
Prospective Registration:	No
Primary sponsor:	Konsortium des GCRRStellvert. Prof. Dr. Oliver SakowitzKlinik für NeurochirurgieKlinikum Ludwigsburg
Public title:	Cranioplasty after 'decompressive' craniectomy - Registry - German Cranial Reconstruction Registry (GCRR)
Scientific title:	Cranioplasty after 'decompressive' craniectomy - Registry - German Cranial Reconstruction Registry (GCRR) - GCRR
Date of first enrolment:	21/04/2015
Target sample size:	1000
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00007931
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
Phase:

Countries of recruitment
Austria	Germany	Switzerland

Contacts

Name:	Henrik Giese
Address:	Im Neuenheimer Feld 400 69120 Heidelberg Germany
Telephone:	06221-566999
Email:	Henrik.Giese@med.uni-heidelberg.de
Affiliation:	Universitätsklinikum Heidelberg - Neurochirurgische Klinik

Name:	Henrik Giese
Address:	Im Neuenheimer Feld 400 69120 Heidelberg Germany
Telephone:	06221-5636574
Email:	Henrik.Giese@med.uni-heidelberg.de
Affiliation:	Universitätsklinikum Heidelberg

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with a clinical condition that requires temporary removal of the cranial bone (decompressive craniectomy, DC)
• Space-occupying cerebral infarction
• Traumatic Brain Injury
• Subarachnoid haemorrhage
• Intracranial haemorrhage
• Sinus venous thrombosis
• Space-occupying cerebral infections

2. Patients after DC which now require surgical cranioplasty (CP)

3. Patients with osteolytic or bone-destructing tumours of the skull

4. Age of (legal) majority

Exclusion criteria: 1. Patients in a clinical condition that requires permanent removal of the cranial bone

2. Patients in palliative care

3. Patients with craniofacial malformations (e.g. craniosynostosis)

4. Patients that require skull base reconstruction

5. Patients after suboccipital DC

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Other nontraumatic intracranial haemorrhage

Intracranial injury

Other cerebrovascular diseases

Intracerebral haemorrhage

Intracranial and intraspinal phlebitis and thrombophlebitis

Cerebral infarction

Subarachnoid haemorrhage

osteolytic or bone-destructing tumours of the skull
I63
S06
I62
I60
I61
G08
I67

Intervention(s)

Group 1: The GCCR is a single-arm observational study. All patients with a "decompressive" or “tumor related” craniectomy and subsequent cranioplasty are analyzed using a structured questionnaire. Patient specific risk factors, surgical details, materials for cranioplasty, intra- and postoperative complications as well as neurological outcome and cosmetic result will be recorded. The investigation period will cover acute complications as well as subsequent problems (e.g. aseptic bone necrosis) and long-term outcome.

Primary Outcome(s)

1) Neurological status (GOS, mRs) before and after 1st and 2nd surgery and at time of re-presentation

2) Overall mortality: death within a period of 3 months ± 14 d after cranioplasty intervention

3) Surgical revision within a period of 3 months ± 14 d after cranioplasty intervention

Secondary Outcome(s)

1) Patient satisfaction after cranioplasty surgery

2) Time to bone flap re-implantation (cranioplasty)

3.) Rate of surgery-related complications of both procedures (craniectomy and cranioplasty) detected up to 30 days after surgery

4) Quality indicators of surgery

Secondary ID(s)

U1111-1168-7425

Source(s) of Monetary Support

Codman DePuy SynthesMichalis NikolaouMarketing Manager - EMEACranial Surgery

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 29/01/2015
Contact:

ethikkommission-I@med.uni-heidelberg.de

Ethikkommission der Medizinischen Fakultät Heidelberg

+49-6221-338220

ethikkommission-I@med.uni-heidelberg.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00007931#studyResults

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