Craniotomy Clinical Trial
Official title:
A Randomised Controlled Trial to Evaluate Decompressive Craniectomy for Patients With Cerebral Herniation Undergoing Evacuation of Acute Epidural Hematoma
Although craniotomy provides a more complete evacuation of the acute epidural hematoma, there are insufficient data to support specific surgical treatment method. We aim to perform a multi-center, parallel-group randomized clinical trial to compare the outcome and cost-effectiveness of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury patients with cerebral herniation undergoing evacuation of an acute epidural hematoma.
The incidence of epidural hematoma (EDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. Among patients in coma, up to 9% harbored an EDH requiring craniotomy. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%. The decision to operate on an acute EDH (AEDH) is usually based on the patient's GCS score, age, pupillary abnormalities, comorbidities, CT findings, associated intracranial lesions, in delayed decisions, the time between neurological deterioration and surgery, and intracranial pressure. An AEDH greater than 30 ml should be surgically evacuated regardless of the patient's Glasgow Coma Scale (GCS) score. There are insufficient data to support one surgical treatment method. However, craniotomy provides a more complete evacuation of the hematoma for patients with an AEDH that require an operation to remove the clot. But whether decompressive craniectomy (DC) should be employed still has considerable controversy. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. The difference between these two procedures is that a bone flap is left out before closing the skin in DC. Both approaches are widely used among neurological surgeons (although the indications may differ), therefore there is sufficient experience in the centers to set up a randomized clinical trial. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02880566 -
Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy
|
N/A | |
| Completed |
NCT05103735 -
Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
|
||
| Completed |
NCT04285359 -
Impact of Severe Intraoperative Hyperglycemia on Infection Rate After Elective Intracranial Interventions
|
||
| Completed |
NCT03364283 -
Sitting Versus Horizontal Position on Craniotomies
|
||
| Completed |
NCT01502540 -
Pain Prevalence After Major Craniotomy
|
N/A | |
| Recruiting |
NCT06157359 -
Effect of SNB on the QoR in Patients Undergoing Supratentorial Tumor Resection
|
N/A | |
| Recruiting |
NCT01474304 -
Intravenous Acetaminophen for Craniotomy Patients
|
Phase 2 | |
| Completed |
NCT01617837 -
The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04229966 -
Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases
|
||
| Completed |
NCT01987648 -
eCRANIO Trial Study on Elective CRAniotomies: Postoperative Neurointensive Care, Imaging and Outcome
|
||
| Recruiting |
NCT05962684 -
A Greek-designed ERAS Protocol in Elective Craniotomy
|
||
| Completed |
NCT05940935 -
The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations
|
||
| Completed |
NCT03033706 -
Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy
|
N/A | |
| Completed |
NCT00658242 -
Craniofacial Surgery Perioperative Registry
|
N/A | |
| Completed |
NCT04859907 -
Bone Flap Fixation Systems For Craniotomy Procedures
|
N/A | |
| Active, not recruiting |
NCT02237716 -
Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery
|
N/A | |
| Recruiting |
NCT01966939 -
Influences of Types of Skull Surgery on Temporomandibular Joint Performance
|
N/A | |
| Completed |
NCT01606969 -
Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution
|
N/A | |
| Completed |
NCT00590499 -
Agitation in Post Operative Neurosurgical Patients
|
N/A | |
| Withdrawn |
NCT01282645 -
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
|
N/A |