Acquired Platelet Function Disorder, Coagulopathy, Glioma, Surgery, Thromboelastometry
Conditions
Keywords
bleeding, clotting tests, neurosurgery, clotting time, maximum clot firmness, kinetics, lysis, primary hemostasis, platelet dysfunction, coagulation
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.
Interventions
PROCEDUREExposure 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).
PROCEDUREExposure 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).
Sponsors
Instituto de Salud Carlos III
Santiago R. Leal-Noval
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of coagulation factor XIII activity | From 24-hour before surgery (baseline) at 48-hour after surgery | Factor XIII chromogenic activity assay. |
| Change of CT / FIBTEM: clotting time (seconds). | 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) | 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 INR: International Normalized Ratio | 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). | 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). | 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) | 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 | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of days | from surgery to hospital discharge, an average of 2 weeks. | length of stay at ICU and hospital |
| perioperative bleeding | from surgery to hospital discharge, an average of 2 weeks. | Any bleeding occurring during this period. |
Countries
Spain
Contacts
Primary ContactSantiago R. Leal-Noval, MD Ph.D
Outcome results
None listed