Prospective Study on Hemostasis Alterations in Patients Undergoing Neuro Surgical Glioma Resection Acronym: (ABCD Study: Acute Brain Coagulopathy Development Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of INR: International Normalized Ratio
研究概览
简要总结
Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective surgeries: glioma or colon cancer resections.
排除标准
- •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.
结局指标
主要结局
Change of INR: International Normalized Ratio
时间窗: 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).
时间窗: 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).
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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).
时间窗: 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)
时间窗: 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
时间窗: From 24-hour before surgery (baseline) at 48-hour after surgery
Factor XIII chromogenic activity assay.
次要结局
- 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.)
研究者
Santiago R. Leal-Noval
Santiago R. Leal-Noval, MD, PhD, Critical Care specialist
Hospitales Universitarios Virgen del Rocío