Clinical Research Directory

MiDura-Study (Neuro-Patch in Duraplasty)

The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer

Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware

The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.

Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors

Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor. At the end of the operation, this covering is carefully closed again. In some cases, the closure might not be completely adequate leading to cerebrospinal fluid leak. This leakage may collect under the scalp or flow out through the surgical wound. When this happens, the surgical wound may not heal properly, and the risk of infection can increase. These complications can delay recovery and may postpone additional treatments, such as radiotherapy or chemotherapy, that are often needed after brain tumor surgery. Although cerebrospinal fluid leakage is less common after supratentorial craniotomy (surgery on the upper part of the brain) than after other types of brain surgery, it remains a challenging complication and has not been well studied in this group of patients. The aim of this study is to determine how often cerebrospinal fluid leakage occurs after supratentorial craniotomy for intracranial tumors, identify factors that increase the risk of leakage, and evaluate how these leaks are managed. Understanding these factors may help reduce the occurrence of cerebrospinal fluid leakage and improve postoperative recovery in the future.

Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General Anesthesia

This study aims to assess the accuracy, repeatability, and reproducibility of preoperative evaluation of Inferior Vena Cava (IVC) collapsibility index and caval aorta index for prediction of hypotension after induction of general anesthesia.

A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive

This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (TN-CFF) to allow clinical study of the TN-CFF device in a greater number of patients.

Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases

This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.

Post Market Study of Tutopatch In Craniotomy

This is a post market prospective, multi-center study of up to 75 participants at approximately 8 clinical study sites. The objective of the study is to evaluate safety by assessing incidence of device and/or procedure related adverse events.

Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic 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.

Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy

This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.

Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

The SPARTA study is a prospective multicenter observational trial in the Netherlands with the aim of identifying the best clinical care in patients with aneurysmal subarachnoidal haemorrhage. Differences in outcome between surgical treatment and endovascular treatment will be explored. Furthermore, cost effectiveness and radiological prognostic factors will be examined.

A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive

This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (TN-CFF) to allow clinical study of the TN-CFF device in a greater number of patients.

Effectiveness of 3D Bone Matrix in Cranioplasty

The objective of this clinical trial is to evaluate the effectiveness of a 3D bone scaffold in relation to a scaffold formed by PCL + β-TCP (polycaprolactone and beta-tricalcium phosphate), compared to the use of PMMA (polymethyl methacrylate) acrylic cement for bone regeneration in patients undergoing cranioplasty in the city of Valdivia, Chile, between the years 2024-2025. The main beneficiaries will be patients, users of the public or private health system, who require bone regeneration. The intermediate beneficiaries are the health team: doctors specialized in surgery and orthopedics, dedicated in their professional work to bone reconstruction and regeneration.

Efficacy and Safety of Non-sedation Trial in Patients After Neurosurgical Craniotomy

Neurosurgical patients may be more vulnerable to stress caused by agitation after craniotomy, due to longer anesthesia duration, delayed extubation and pain and post-craniotomy frontal pneumocephalus and so on. Analgesia and sedation are important to the neurosurgical patients. However, there is little data to document the effects of protocolised analgesia and sedation on patients with neurological injury. The analgesia and sedation for neurosurgical patients is complex and difficult. The aim of the study is to explore the efficacy and safety of non-sedation strategies in patients admitted to ICU after neurosurgery craniotomy. This is a single-arm, single center, prospective clinical trial. Sixty- five adult patients whose Richmond Agitation-Sedation Scale (RASS) score greater than 1 point and intensive care unit (ICU) stay \> 24 hours after neurosurgical craniotomy will be enrolled. Patients eligible for this study will undergo non-sedation strategy, which continuous analgesia without sedation is performed with remifentanil. The remifentanil will be titrated (from 0.1µg/kg/min to 0.2ug/kg/min) every 10-15 minutes to achieve the goal for sedation (RASS score maintaining -2 to + 1). The patients in the non-sedation trial do not receive any sedatives but could receive bolus doses (2.5 or 5mg) of morphine for analgesia. The primary endpoints is the rate of successful sedation using non-sedation trials in the patients after neurosurgical craniotomy in ICU, defined as 1) RASS score -2 to +1. 2) No additional sedation required (any sedation medicine). The safety endpoints are the incidence of adverse events, including accidental removal of tubes (tracheal reintubation within 2 hours after extubation and reintubation of central venous catheterization (CVC) or gastric tube within 4h), significant agitation (RSAA score greater than 2), occurrences of need for CT or MRI brain scans.