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

NCT ID: NCT01267305

Last Updated: 2014-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-08-31

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.

Detailed Description

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Conditions

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Lung Neoplasms Esophageal Neoplasms Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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lung lmwh1

use LMWH once daily after lung resection

Group Type ACTIVE_COMPARATOR

Nadroparin Calcium

Intervention Type DRUG

4100AxaIU IH qd(8AM) after operation

lung lmwh2

use LMWH twice daily after lung resection

Group Type EXPERIMENTAL

Nadroparin Calcium

Intervention Type DRUG

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

lung Fondaparinux

use Fondaparinux once daily after lung resection

Group Type EXPERIMENTAL

Fondaparinux

Intervention Type DRUG

2.5mg IH qd(8AM) after operation

eso lmwh1

use LMWH once daily after esophagectomy

Group Type ACTIVE_COMPARATOR

Nadroparin Calcium

Intervention Type DRUG

4100AxaIU IH qd(8AM) after operation

eso lmwh2

use LMWH twice daily after esophagectomy

Group Type EXPERIMENTAL

Nadroparin Calcium

Intervention Type DRUG

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

eso Fondaparinux

use Fondaparinux once daily after esophagectomy

Group Type EXPERIMENTAL

Fondaparinux

Intervention Type DRUG

2.5mg IH qd(8AM) after operation

Interventions

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Fondaparinux

2.5mg IH qd(8AM) after operation

Intervention Type DRUG

Nadroparin Calcium

4100AxaIU IH qd(8AM) after operation

Intervention Type DRUG

Nadroparin Calcium

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

Intervention Type DRUG

Other Intervention Names

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ARIXTRA H20080111 Fraxiparine Fraxiparine

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming Zhong

department of anesthesiology and surgical intensive care unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lizhen Xuan

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

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Zhongshan Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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SICUTEG-01

Identifier Type: -

Identifier Source: org_study_id

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