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Hematoma clinical trials

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NCT ID: NCT04607447 Recruiting - Clinical trials for Chronic Subdural Hematoma

Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

CSDH-LP
Start date: August 4, 2020
Phase: N/A
Study type: Interventional

The proportion of the elderly population is increasing rapidly. Chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. The standard treatment for cSDH is mostly surgery. Clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. At present, the mechanism of cSDH is not completely clear. Our previous observational studies had shown significant correlation between cSDH and intracranial hypotension. So we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.

NCT ID: NCT04574843 Recruiting - Clinical trials for Chronic Subdural Hematoma

Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)

NCT ID: NCT04573387 Recruiting - Clinical trials for Hematoma, Subdural, Chronic

Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy

ECHO
Start date: December 29, 2020
Phase: N/A
Study type: Interventional

A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.

NCT ID: NCT04559646 Completed - Clinical trials for Hematoma Postoperative

Application of the "Haemoblock" in Pacemaker Patients

Start date: January 1, 2021
Phase:
Study type: Observational

Pocket hematoma is a known complication of pacemaker (PM) implantation. Pocket hematoma is accompanied by a local discomfort associated with the infiltration of subcutaneous tissue. In some cases, this complication requires repeated surgical revisions, which increases the risk of infection, and increases the duration of a hospital stay. The search for ways to prevent bleeding from the PM pocket is of great practical interest. This question is especially acute in relation to patients who are constantly on anticoagulation and/or antiplatelet therapy. A number of authors propose to carry out complete or partial cancellation of these drugs for the period before surgery and in the early postoperative period. In our opinion, this approach in most cases carries a potential risk to the health of patients, especially in the case of patients who have previously undergone surgical correction of valve insufficiency and/or who have undergone percutaneous endovascular interventions. The use of local hemostatic drugs is one of the promising directions for increasing the efficiency of intraoperative hemostasis. The haemostatic solution "Haemoblock" has shown its hemostatic potential in general surgical practice. The possibilities of "Haemoblock" in the prevention of pocket hematoma have not been studied. The hemostatic effect of "Haemoblock" is achieved within 1-2 minutes due to the formation of a clot with blood plasma proteins, first of all with albumin. As a result of the action of the "Haemoblock", a strong polymethacrylate membrane is formed on the surface of the wound, which, among other things, has a bactericidal effect.

NCT ID: NCT04554407 Active, not recruiting - Clinical trials for Hematoma Postoperative

Study to Evaluate the Performance of a Sustained Vacuum System

Start date: August 11, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.

NCT ID: NCT04511572 Recruiting - Clinical trials for Chronic Subdural Hematomas

Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma

ELIMINATE
Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Chronic subdural hematoma (cSDH) is a common neurological affliction which affects mostly frail and elderly patients. Surgical evacuation by using burr hole craniostomy (BHC) is the most frequently used treatment but carries a recurrence rate varying between 10-30% in the literature. Especially in this frail population re-operation is undesirable. Embolization of the middle meningeal artery is an adjuvant treatment which has been reported in multiple case reports and larger case series, showing a beneficial effect on recurrence rate, reducing it to <5%, without complications. Objectives: Primary: To evaluate whether additional embolization of the middle meningeal artery after surgery for cSDH reduces the recurrent surgery rate. Secondary: to evaluate whether the use of middle meningeal artery embolization after surgical treatment in symptomatic cSDH patients increases quality of life (SF-36 and the EQ-5D-5L), performance in activities of daily living (AMC Linear Disability Score), functional outcome (mRS), cognitive functioning (MOCA) and reduces mortality, occurrence of complications, recurrence rate, size and volume of the hematoma, neurological impairment (mNIHSS, Markwalder score) and the use of care and health-related costs (iMCQ and iPCQ). Study design: Multicenter, randomized controlled open-label superiority trial. Study population: Patients diagnosed with a cSDH who require surgery. Intervention: The intervention group will receive embolization in addition to standard surgical treatment. The control group will receive surgery only. Main study endpoint: The number of patients who require reoperation within 24 weeks after the intervention. Symptomatic cSDH patients will undergo peri-operative embolization of the middle meningeal artery until 72 hours after surgical treatment. Complications are monitored during hospital admission and follow-up. Radiological and clinical follow-up is at eight, 16 and 24 weeks post-intervention with a CT-scan of the head and assessment of mRS, MOCA, mNIHSS, Markwalder score, SF-36, EQ-5D-5L, ALDS, iMCQ and iPCQ. Standard care after surgery entails outpatient follow-up with on average two CT-scans, indicated by clinical signs and symptoms.

NCT ID: NCT04505293 Completed - Head Trauma Clinical Trials

Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

Start date: October 5, 2021
Phase: N/A
Study type: Interventional

The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.

NCT ID: NCT04502745 Terminated - Clinical trials for Chronic Subdural Hematoma

A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.

NCT ID: NCT04500795 Withdrawn - Clinical trials for Chronic Subdural Hematoma

Prospective Study on the Use of Middle Meningeal Artery Embolization for Chronic Subdural Haematoma

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Subdural haematoma is a common neurosurgical condition that results in different levels of neurological deficits in patients. It can be further classified into acute and chronic, which have different pathophysiology. Acute haematoma is a common result of traumatic injuries involving the tearing of the bridging veins, while chronic subdural haematoma can be both a result of traumatic injuries or recurrence following surgical management of the acute counterpart. For symptomatic patients, they are often surgically managed by haematoma drainage via burr-hole drainage and craniotomy. Recurrent bleeding following close monitor or surgical evacuation of haematoma is however very high. Recent studies approximate the recurrence rate of 2%-33.3%. Recent evidence suggests the angiogenesis of middle meningeal arteries (MMA) in response to inflammation and healing process contributes to the development of chronic subdural haematoma, and its high recurrence chance. Several studies have looked into the use of middle meningeal artery embolization to halt the bleeding of a chronic subdural haematoma, and have found promising results in terms of haematoma reduction and prevention of surgical rescues.

NCT ID: NCT04496180 Not yet recruiting - Clinical trials for Surgical Site Infection

Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy

CiPNT/SSI
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Post-operative wound complications in abdominal surgery have a major impact on patient outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not clear in the literature moreover concerning its potential economic benefits The hypothesis of this study is that CINPt has the potential to reduce Surgical Site Infections. Secondly the investigators aim to study the economic impact of CINPt used after abdominal emergency laparotomies.