Hemostasis Alterations in Neurosurgical Patients (ABCD)

Santiago R. Leal-Noval

Status: Unknown

Conditions: Glioma; Coagulopathy; Surgery; Acquired Platelet Function Disorder; Thromboelastometry

Treatments: Procedure: Exposure to glioma resection surgery; Procedure: Exposure to colon resection surgery

Study type: Observational

Funder types: Other

Identifiers

NCT02652897

FIS PI15 / 00512

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Exposure to glioma resection surgery

Description:

Patients undergoing elective glioma resection

Treatment:

Procedure: Exposure to glioma resection surgery

Exposure to colon resection surgery

Description:

Patients undergoing elective colon cancer resection

Treatment:

Procedure: Exposure to colon resection surgery