Prospective Study on Hemostasis Alterations in Patients Undergoing Neuro Surgical Glioma Resection Acronym: (ABCD Study: Acute Brain Coagulopathy Development Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glioma
- Sponsor
- Santiago R. Leal-Noval
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change of INR: International Normalized Ratio
- Last Updated
- 7 years ago
Overview
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.
Investigators
Santiago R. Leal-Noval
Santiago R. Leal-Noval, MD, PhD, Critical Care specialist
Hospitales Universitarios Virgen del Rocío
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.
Outcomes
Primary Outcomes
Change of INR: International Normalized Ratio
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing INR (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of aPTT: activated partial thromboplastin time (seconds).
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing aPTT (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of CT / EXTEM: clotting time (seconds).
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing CT / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of MCF / EXTEM: maximum clot firmness (mm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing MCF / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of ML / EXTEM: Maximum lysis (%) percentage of clot which has actually lysed
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing ML (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of col EPI (PFA-200): collage epinephrine bitartrate ( seconds)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing col EPI (measured by platelet function analyzer : PFA-200 test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of ara-tem / ROTEM values : platelet activation with arachidonic acid (ohm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm\* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of adp-tem / ROTEM values : platelet activation with adenosine diphosphate (ohm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm\* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of trap-tem / ROTEM values : platelet activation with thrombin activating peptide (ohm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm\* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of CT / FIBTEM: clotting time (seconds).
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing CT / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of MCF / FIBTEM: maximum clot firmness (mm)
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Blood samples for assessing MCF / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.
Change of coagulation factor XIII activity
Time Frame: From 24-hour before surgery (baseline) at 48-hour after surgery
Factor XIII chromogenic activity assay.
Secondary Outcomes
- perioperative bleeding(from surgery to hospital discharge, an average of 2 weeks.)
- number of days(from surgery to hospital discharge, an average of 2 weeks.)