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

April 28, 2014 updated by: Ming Zhong, Shanghai Zhongshan Hospital
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Shanghai, China, 200032
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lung lmwh1
use LMWH once daily after lung resection
4100AxaIU IH qd(8AM) after operation
Other Names:
  • Fraxiparine
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
  • Fraxiparine
Experimental: lung lmwh2
use LMWH twice daily after lung resection
4100AxaIU IH qd(8AM) after operation
Other Names:
  • Fraxiparine
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
  • Fraxiparine
Experimental: lung Fondaparinux
use Fondaparinux once daily after lung resection
2.5mg IH qd(8AM) after operation
Other Names:
  • ARIXTRA
  • H20080111
Active Comparator: eso lmwh1
use LMWH once daily after esophagectomy
4100AxaIU IH qd(8AM) after operation
Other Names:
  • Fraxiparine
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
  • Fraxiparine
Experimental: eso lmwh2
use LMWH twice daily after esophagectomy
4100AxaIU IH qd(8AM) after operation
Other Names:
  • Fraxiparine
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
  • Fraxiparine
Experimental: eso Fondaparinux
use Fondaparinux once daily after esophagectomy
2.5mg IH qd(8AM) after operation
Other Names:
  • ARIXTRA
  • H20080111

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TEG values
Time Frame: 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
three days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding quantity of chest drainage
Time Frame: three days after surgery
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)
Time Frame: after surgery up to 7 days
incidence of DVT is measured by vascular ultrasonography
after surgery up to 7 days
inhospital mortality
Time Frame: after surgery up to 28 days
the number of death in the period of hospital stay
after surgery up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lizhen Xuan, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 25, 2010

First Submitted That Met QC Criteria

December 25, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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