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

Fudan University

Status: Completed

Conditions: Lung Neoplasms; Venous Thromboembolism; Esophageal Neoplasms

Treatments: Drug: Fondaparinux; Drug: Nadroparin Calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT01267305

SICUTEG-01

Details and patient eligibility

About

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.

Enrollment: 362 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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362 participants in 6 patient groups

lung lmwh1

Active Comparator group

Description:

use LMWH once daily after lung resection

Treatment:

Drug: Nadroparin Calcium

Drug: Nadroparin Calcium

lung lmwh2

Experimental group

Description:

use LMWH twice daily after lung resection

Treatment:

Drug: Nadroparin Calcium

Drug: Nadroparin Calcium

lung Fondaparinux

Experimental group

Description:

use Fondaparinux once daily after lung resection

Treatment:

Drug: Fondaparinux

eso lmwh1

Active Comparator group

Description:

use LMWH once daily after esophagectomy

Treatment:

Drug: Nadroparin Calcium

Drug: Nadroparin Calcium

eso lmwh2

Experimental group

Description:

use LMWH twice daily after esophagectomy

Treatment:

Drug: Nadroparin Calcium

Drug: Nadroparin Calcium

eso Fondaparinux

Experimental group

Description:

use Fondaparinux once daily after esophagectomy

Treatment:

Drug: Fondaparinux