The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of different dose of LMWH compared with fondaparinux for thromboprophylaxis is efficacious and safety after thoracic surgery.

Official Title
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The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery

Conditions
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Lung Neoplasms, Esophageal Neoplasms, Venous Thromboembolism

Intervention / Treatment
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* Drug: Fondaparinux
* Drug: Nadroparin Calcium
* Drug: Nadroparin Calcium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of esophageal carcinoma and planned for esophagectomy clinical diagnosis of lung carcinoma and planned for lung resection general anesthesia combined with epidural anesthesia Exclusion Criteria: blood clotting disfunction before surgery anticoagulating or antiplatelet history before surgery low blood platelets count hemorrhagic disease cerebral hemorrhage cerebral,spinal,ophthalmologic operation history peptic ulcer bleeding>400ml in operation bleeding>100ml/h after operation blood transfusion in or after operation severe renal or liver disfunction severe hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lung lmwh1<br>use LMWH once daily after lung resection | Drug: Nadroparin Calcium<br>* 4100AxaIU IH qd(8AM) after operation<br>* Other names: Fraxiparine;|
| Experimental: lung lmwh2<br>use LMWH twice daily after lung resection | Drug: Nadroparin Calcium<br>* 4100AxaIU IH q12h(8Am,8Pm) after operation<br>* Other names: Fraxiparine;|
| Experimental: lung Fondaparinux<br>use Fondaparinux once daily after lung resection | Drug: Fondaparinux<br>* 2.5mg IH qd(8AM) after operation<br>* Other names: H20080111;|
| Active Comparator: eso lmwh1<br>use LMWH once daily after esophagectomy | Drug: Nadroparin Calcium<br>* 4100AxaIU IH qd(8AM) after operation<br>* Other names: Fraxiparine;|
| Experimental: eso lmwh2<br>use LMWH twice daily after esophagectomy | Drug: Nadroparin Calcium<br>* 4100AxaIU IH q12h(8Am,8Pm) after operation<br>* Other names: Fraxiparine;|
| Experimental: eso Fondaparinux<br>use Fondaparinux once daily after esophagectomy | Drug: Fondaparinux<br>* 2.5mg IH qd(8AM) after operation<br>* Other names: H20080111;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEG values | 1.5ml aterial blood sample will be obtained daily for TEG , and the vulues of TEG,such as R,K,Alpha angle,MA,G,CI ,will be measured | three days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding quantity of chest drainage | all drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding | three days after surgery | 
| incidence rate of deep venous thromboembolism（DVT) | incidence of DVT is measured by vascular ultrasonography | after surgery up to 7 days | 
| inhospital mortality | the number of death in the period of hospital stay | after surgery up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophagectomy, lung resection, venous thromboembolism, low molecular weight heparin, chest drainage, TEG