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

Not Applicable

Completed

• Conditions: Lung Neoplasms; Esophageal Neoplasms; Venous Thromboembolism
• Interventions: Drug: Nadroparin Calcium; Drug: Fondaparinux

• Registration Number: NCT01267305
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-25
• Study First Submitted QC: 2010-12-25
• Study First Posted: 2010-12-28
• Study Start: 2011-01
• Primary Completion: 2013-04
• Study Completion: 2013-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-28
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eso lmwh2	Nadroparin Calcium	use LMWH twice daily after esophagectomy
eso Fondaparinux	Fondaparinux	use Fondaparinux once daily after esophagectomy
lung lmwh1	Nadroparin Calcium	use LMWH once daily after lung resection
lung lmwh2	Nadroparin Calcium	use LMWH twice daily after lung resection
lung Fondaparinux	Fondaparinux	use Fondaparinux once daily after lung resection
eso lmwh1	Nadroparin Calcium	use LMWH once daily after esophagectomy

Primary Outcome Measures

Name	Time	Method
TEG values	three days after surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, China