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临床试验/NCT01608971
NCT01608971已完成不适用

The Effects of Heparin Level Based Versus Weight Based Protamine Dosing on Protamine Demand, Markers of Haemostasis, Blood Product Utilization and Perioperative Blood Loss in Patients Undergoing Extended Cardiac Surgery Cardiac Surgery

Heart and Diabetes Center North-Rhine Westfalia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Rotem MCF Fibtem and MCF Intem

研究概览

简要总结

Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a protamine regimen based on the initial heparin dose before CPB might lead to overdose of protamine. In contrast, a protamine regimen based on the actual heparin concentration may avoid this condition. The investigators compare both regimens of protamine dosing in patients undergoing complex surgery with CPB and assess its effect on the amount of protamine given, markers of the coagulation system, utilization of blood products and perioperative blood loss.

详细描述

Before induction of anesthesia, patients are randomized to the two different dosing regimen for protamine. Both, the anesthetist and the surgeon were blinded regarding the grouping of the patients.

Anesthesia and CPB

Anesthesia is performed as a balanced anesthesia with a bolus of fentanyl, etomidate, pancuronium-bromide followed by a continuous infusion of remifentanil and vaporization of sevoflurane. Additionally, in all patients a continuous infusion of 0.25 µg/kg/min milrinone will be started after induction of anesthesia. Further inotropic or vasoactive agents (Dobutamine 3-5 µg/kg/min; epinephrine 0.05-0.2 µg(kg/min, norepinephrine 0.05-0.2 µg/kg/min) will be only given when a target cardiac index of < 2.2 l/m² BSA and mean arterial pressure of >70 mmHg is not achieved with this therapy.

In order to compensate the degree of hemodilution due to differences in weight, in patients with a body surface area (BSA) of <1.8 m², a CPB system with a priming volume of 1100 ml will be used while in patients with a BSA of >1.8m² a system with a priming volume of 1500 ml was employed. CBP will be performed with open non-coated CPB circuits in mild hypothermia with a core temperature of 32-34°C. Cardioplegia will be achieved using warm blood cardioplegia according to Calafiore.

All patients receive tranexamic acid (TA) with a bolus of 1 g to the patient, 0.5 g added to the CPB volume and a continuous infusion of 0.2 g/hour during CPB.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary surgery
  • Preoperative hemoglobin value < 12 g/l
  • Preoperative platelet count < 200 c/µl
  • Patients with a body weight < 50 kg
  • No known defect of the coagulation system
  • Normal pre-operative ROTEM values of the INTEM and FIBTEM
  • Patients with unimpaired renal function (creatinine clearance < 30 ml/kg/min)

排除标准

  • <18 years
  • No informed consent
  • Re-do surgery
  • Known defect of the coagulation system
  • Renal impairment

结局指标

主要结局

Rotem MCF Fibtem and MCF Intem

时间窗: 15 Minutes after protamine infusion

The following parameters of the INTEM test will be analyzed: MCF \[mm\] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF \[mm\] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.

INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer

时间窗: Tests will be measured 15 minutes after Protamine infusion

The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT \[seconds\](coagulation time), CFT \[seconds\] (clot formation time) and the CT \[seconds\] of the HEPTEM test which is non sensitive for residual heparine.

次要结局

  • 12 h Postoperative Blood Loss(15 min after protamine administration until 12 hours postoperatively)
  • Transfusion of Blood Products and Coagulation Factors(From protamine administration until 12 h after surgery)

研究者

发起方
Heart and Diabetes Center North-Rhine Westfalia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Koster

Senior anaestetist

Heart and Diabetes Center North-Rhine Westfalia

研究点 (1)

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