Clinical trial NCT02652897: Hemostasis Alterations in Neurosurgical Patients
Official title: Prospective Study on Hemostasis Alterations in Patients Undergoing Neuro Surgical Glioma Resection Acronym: (ABCD Study: Acute Brain Coagulopathy Development Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Coagulopathy
Acquired Platelet Function Disorder
Thromboelastometry
Surgery
Keywords: bleeding
clotting tests
neurosurgery
clotting time
maximum clot firmness
kinetics
lysis
primary hemostasis
platelet dysfunction
coagulation
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2016-01-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing elective glioma (study group) and colon (control group) surgeries.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of INR: International Normalized Ratio
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of aPTT: activated partial thromboplastin time (seconds).
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of CT / EXTEM: clotting time (seconds).
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of MCF / EXTEM: maximum clot firmness (mm)
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of ML / EXTEM: Maximum lysis (%) percentage of clot which has actually lysed
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of col EPI (PFA-200): collage epinephrine bitartrate ( seconds)
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of ara-tem / ROTEM values : platelet activation with arachidonic acid (ohm)
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of adp-tem / ROTEM values : platelet activation with adenosine diphosphate (ohm)
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of trap-tem / ROTEM values : platelet activation with thrombin activating peptide (ohm)
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of CT / FIBTEM: clotting time (seconds).
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of MCF / FIBTEM: maximum clot firmness (mm)
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
measure: Change of coagulation factor XIII activity
timeFrame: From 24-hour before surgery (baseline) at 48-hour after surgery
Secondary outcomes:
measure: perioperative bleeding
timeFrame: from surgery to hospital discharge, an average of 2 weeks.
measure: number of days
timeFrame: from surgery to hospital discharge, an average of 2 weeks.
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Santiago R. Leal-Noval
Study officials:
affiliation: University Hospital "Virgen del Rocío", Seville, Spain
name: Santiago R. Leal-Noval, MD Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leal-Noval SR, Fernandez-Pacheco J, Casado-Mendez M, Cancela P, Narros JL, Arellano-Orden V, Dusseck R, Diaz-Martin A, Munoz-Gomez M. A prospective study on the correlation between thromboelastometry and standard laboratory tests - influence of type of surgery and perioperative sampling times. Scand J Clin Lab Invest. 2020 May;80(3):179-184. doi: 10.1080/00365513.2019.1704051. Epub 2019 Dec 17.