Hemostasis Alterations in Neurosurgical Patients

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-03-31

Brief Summary

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

Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.

Related Clinical Trials

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

Major Liver Resection: Early Clotting Disorders and Functional Impairment.

NCT02813538

Hepatic Insufficiency Blood Coagulation Disorders

COMPLETED

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

NCT04322721

Traumatic Brain Injury Coagulation Disorder

COMPLETED

Correlation Between Reticulated Platelets and Major Adverse Cardiac and Cerebrovascular Events After Noncardiac Surgery

NCT02097602

Cardiac Death Congestive Heart Failure Angina Pectoris +3 more

COMPLETED

Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery

NCT01606865

Postoperative Bleeding

COMPLETED

Management of Anticoagulants and Antithrombotics in Patients With CSDH

NCT05079295

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

UNKNOWN

Detailed Description

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

Brain parenchyma express tissue factor and other coagulation factors in high concentrations. In addition, neuro critical patients (NCP) may present platelet dysfunction, hyperfibrinolysis, hypo coagulation and / or hyper coagulation status, early after the injury. It is not known whether these alterations of hemostasis are due to a specific brain response to aggression, or they are included into a systemic response. This prospective, observational study is aimed to investigate the coagulation disorders specifically associated with cerebral aggression.

This is a prospective, cohort study including (calculated sample size) a study group of patients undergoing elective surgery (glial tumors) and other one undergoing colo rectal surgery. Alterations of the hemostasis will be evaluated by clotting tests, thromboelastometry and tests for platelet function. Samples will be drawn before and after surgical procedures. Multiple statistical comparisons intra and inter groups will be performed.

Conditions

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

Glioma Coagulopathy Acquired Platelet Function Disorder Thromboelastometry Surgery

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Exposure to glioma resection surgery

Patients undergoing elective glioma resection

Exposure to glioma resection surgery

Intervention Type PROCEDURE

The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).

Exposure to colon resection surgery

Patients undergoing elective colon cancer resection

Exposure to colon resection surgery

Intervention Type PROCEDURE

The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).

Interventions

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

Exposure to glioma resection surgery

The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).

Intervention Type PROCEDURE

Exposure to colon resection surgery

The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Patients undergoing elective surgeries: glioma or colon cancer resections.

Exclusion Criteria

* Severe bleeding leading to patient's' death.
* Incomplete tumor resection.
* Peri operative complications leading to severe bleeding or prolonged ICU or hospital stay.
* Peri operative blood components transfusion.
* Peri operative transfusion of concentrate coagulation factors.
* Intake of anti coagulant and / or antiaggregant drugs 7 days before surgery.
* History of coagulopathy.
* Inform consent denied for patients or relatives.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No