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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure to glioma resection surgery | Patients undergoing elective glioma resection |
| |
| Exposure to colon resection surgery | Patients undergoing elective colon cancer resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure to glioma resection surgery | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of INR: International Normalized Ratio | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of aPTT: activated partial thromboplastin time (seconds). | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of CT / EXTEM: clotting time (seconds). | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of MCF / EXTEM: maximum clot firmness (mm) | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of ML / EXTEM: Maximum lysis (%) percentage of clot which has actually lysed | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative bleeding | Any bleeding occurring during this period. | from surgery to hospital discharge, an average of 2 weeks. |
| number of days | length of stay at ICU and hospital |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients undergoing elective glioma (study group) and colon (control group) surgeries.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Santiago R. Leal-Noval, MD Ph.D | Contact | 0034955012528 | 312528 | srlealnoval@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Santiago R. Leal-Noval, MD Ph.D | University Hospital "Virgen del RocÃo", Seville, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santiago R. Leal-Noval | Recruiting | Seville | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36945200 | Derived | Leal-Noval SR, Cuenca DX, Diaz A, Fernandez-Pacheco J, Garcia-Garmendia JL, Casado M. Whole Blood Platelet Aggregation Assessed by ROTEM Platelet Equipment in Healthy Volunteers from Southern Europe: A Verification Study. J Appl Lab Med. 2023 May 4;8(3):551-558. doi: 10.1093/jalm/jfad008. | |
| 31846350 | Derived |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Exposure to colon resection surgery | 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). |
|
| From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of col EPI (PFA-200): collage epinephrine bitartrate ( seconds) | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of ara-tem / ROTEM values : platelet activation with arachidonic acid (ohm) | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of adp-tem / ROTEM values : platelet activation with adenosine diphosphate (ohm) | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of trap-tem / ROTEM values : platelet activation with thrombin activating peptide (ohm) | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of CT / FIBTEM: clotting time (seconds). | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of MCF / FIBTEM: maximum clot firmness (mm) | 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. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| Change of coagulation factor XIII activity | Factor XIII chromogenic activity assay. | From 24-hour before surgery (baseline) at 48-hour after surgery |
| from surgery to hospital discharge, an average of 2 weeks. |
| 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. |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |