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

Primary Purpose

Lung Neoplasms, Esophageal Neoplasms, Venous Thromboembolism

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Fondaparinux

Nadroparin Calcium

About this trial

This is an interventional prevention trial for Lung Neoplasms focused on measuring esophagectomy, lung resection, venous thromboembolism, low molecular weight heparin, chest drainage, TEG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

lung lmwh1

lung lmwh2

lung Fondaparinux

eso lmwh1

eso lmwh2

eso Fondaparinux

Arm Description

use LMWH once daily after lung resection

use LMWH twice daily after lung resection

use Fondaparinux once daily after lung resection

use LMWH once daily after esophagectomy

use LMWH twice daily after esophagectomy

use Fondaparinux once daily after esophagectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

bleeding quantity of chest drainage

all drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding

incidence rate of deep venous thromboembolism（DVT)

incidence of DVT is measured by vascular ultrasonography

inhospital mortality

the number of death in the period of hospital stay

Full Information

NCT ID

NCT01267305

First Posted

December 25, 2010

Last Updated

April 28, 2014

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01267305

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms, Esophageal Neoplasms, Venous Thromboembolism

Keywords

esophagectomy, lung resection, venous thromboembolism, low molecular weight heparin, chest drainage, TEG

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

362 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lung lmwh1

Arm Type

Active Comparator

Arm Description

use LMWH once daily after lung resection

Arm Title

lung lmwh2

Arm Type

Experimental

Arm Description

use LMWH twice daily after lung resection

Arm Title

lung Fondaparinux

Arm Type

Experimental

Arm Description

use Fondaparinux once daily after lung resection

Arm Title

eso lmwh1

Arm Type

Active Comparator

Arm Description

use LMWH once daily after esophagectomy

Arm Title

eso lmwh2

Arm Type

Experimental

Arm Description

use LMWH twice daily after esophagectomy

Arm Title

eso Fondaparinux

Arm Type

Experimental

Arm Description

use Fondaparinux once daily after esophagectomy

Intervention Type

Drug

Intervention Name(s)

Fondaparinux

Other Intervention Name(s)

ARIXTRA, H20080111

Intervention Description

2.5mg IH qd(8AM) after operation

Intervention Type

Drug

Intervention Name(s)

Nadroparin Calcium

Other Intervention Name(s)

Fraxiparine

Intervention Description

4100AxaIU IH qd(8AM) after operation

Intervention Type

Drug

Intervention Name(s)

Nadroparin Calcium

Other Intervention Name(s)

Fraxiparine

Intervention Description

4100AxaIU IH q12h(8Am,8Pm) after operation

Primary Outcome Measure Information:

Title

TEG values

Description

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

Time Frame

three days after surgery

Secondary Outcome Measure Information:

Title

bleeding quantity of chest drainage

Description

all drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding

Time Frame

three days after surgery

Title

incidence rate of deep venous thromboembolism（DVT)

Description

incidence of DVT is measured by vascular ultrasonography

Time Frame

after surgery up to 7 days

Title

inhospital mortality

Description

the number of death in the period of hospital stay

Time Frame

after surgery up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lizhen Xuan

Organizational Affiliation

Shanghai Zhongshan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital

City

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

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

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