Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (\>3 months after DHC) and those receiving early cranioplasty (within 8 weeks).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Coagulopathy on the First Postoperative Day Predicts the Long-term Survival of Traumatic Brain Injury Patients

NCT04322721

Traumatic Brain Injury Coagulation Disorder

COMPLETED

Management of Anticoagulants and Antithrombotics in Patients With CSDH

NCT05079295

Chronic Subdural Hematoma Anticoagulant-induced Bleeding Thromboembolic Stroke +1 more

UNKNOWN

Minimally Invasive Surgery For Patients With Spontaneous Deep Intracerebral Hemorrhage

NCT07234955

Intracerebral Hemorrhage Basal Ganglia Intracerebral Haemorrhage

RECRUITING

An Observational Study of Early Coagulopathy, or Clotting Disorder, in Injured Patients

NCT00744003

Trauma-induced Coagulopathy

WITHDRAWN

Coagulopathy in Cardiac Surgery

NCT03475940

Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (\>3 months after DHC) and those receiving early cranioplasty (within 8 weeks).

The primary endpoint involves a comprehensive evaluation of long-term functional outcomes at 6 months post-injury ("injury" defined as "acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage"). This assessment aims to determine whether the timing of cranioplasty influences patients' neurological recovery, cognitive function, and overall quality of life. By comparing the outcomes of patients who undergo standard of care cranioplasty with those who undergo early cranioplasty, the study seeks to provide valuable insights into the potential benefits of the latter approach.

The findings of this research hold the potential to guide clinical practice and inform decision-making for patients who have undergone DHC. By considering a range of complications and incorporating a robust statistical framework, the study contributes to a more nuanced understanding of the advantages and disadvantages associated with different cranioplasty timing strategies.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Craniocerebral Trauma Stroke Intracranial Hemorrhages

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The collection of outcomes will be performed without regard to the treatment versus control arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early cranioplasty

Cranioplasty procedure performed prior to 8 weeks following the initial decompressive hemicraniectomy.

Group Type ACTIVE_COMPARATOR

Early cranioplasty

Intervention Type PROCEDURE

Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Early cranioplasty is defined as being performed within 8 weeks following the decompressive hemicraniectomy.

Standard-of-care cranioplasty

Cranioplasty procedure performed after 3 months following the initial decompressive hemicraniectomy.

Group Type PLACEBO_COMPARATOR

Standard-of-care cranioplasty

Intervention Type PROCEDURE

Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Standard-of-care cranioplasty is defined as being performed after 3 months following the decompressive hemicraniectomy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Early cranioplasty

Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Early cranioplasty is defined as being performed within 8 weeks following the decompressive hemicraniectomy.

Intervention Type PROCEDURE

Standard-of-care cranioplasty

Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Standard-of-care cranioplasty is defined as being performed after 3 months following the decompressive hemicraniectomy.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults of age greater than or equal to 18 years at the time of acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage necessitating decompressive hemicraniectomy (DHC)
* Patient's cranial flap fulfills Craniectomy Contour Class A or B after 4 weeks postoperatively (doi:10.1227/ons.0000000000000689)
* Medically optimized for general anesthesia/surgery

Exclusion Criteria

* Active systemic infection in weeks 6-8 post-DHC leading up to cranioplasty (e.g. pneumonia, urinary tract infection, soft tissue infection, bacteremia)
* Cranial infection in the post-DHC period
* Patient deemed not appropriate for early cranioplasty by attending neurosurgeon
* Patient mortality prior to 8 weeks post-injury ("injury" defined as "acute traumatic injury or source of increased intracranial pressure causing brain injury secondary to stroke or intracranial hemorrhage")

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes