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

This study is currently recruiting participants.
Verified December 2012 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Ming Zhong, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01267305
First received: December 25, 2010
Last updated: December 2, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Lung Neoplasms
Esophageal Neoplasms
Venous Thromboembolism
 Drug: Fondaparinux
Drug: Nadroparin Calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • TEG values [ Time Frame: three days after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: three days after surgery ] [ Designated as safety issue: Yes ]
    all drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding

  • incidence rate of deep venous thromboembolism（DVT) [ Time Frame: after surgery up to 7 days ] [ Designated as safety issue: Yes ]
    incidence of DVT is measured by vascular ultrasonography

  • inhospital mortality [ Time Frame: after surgery up to 28 days ] [ Designated as safety issue: Yes ]
    the number of death in the period of hospital stay


Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lung lmwh1
use LMWH once daily after lung resection
 Drug: Nadroparin Calcium
4100AxaIU IH qd(8AM) after operation
Other Names:
  • Nadroparin Calcium
  • Fraxiparine
Experimental: lung lmwh2
use LMWH twice daily after lung resection
 Drug: Nadroparin Calcium
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
  • Nadroparin Calcium
  • Fraxiparine
Experimental: lung Fondaparinux
use Fondaparinux once daily after lung resection
 Drug: Fondaparinux
2.5mg IH qd(8AM) after operation
Other Names:
  • ARIXTRA
  • H20080111
Active Comparator: eso lmwh1
use LMWH once daily after esophagectomy
 Drug: Nadroparin Calcium
4100AxaIU IH qd(8AM) after operation
Other Names:
  • Nadroparin Calcium
  • Fraxiparine
Experimental: eso lmwh2
use LMWH twice daily after esophagectomy
 Drug: Nadroparin Calcium
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
  • Nadroparin Calcium
  • Fraxiparine
Experimental: eso Fondaparinux
use Fondaparinux once daily after esophagectomy
 Drug: Fondaparinux
2.5mg IH qd(8AM) after operation
Other Names:
  • ARIXTRA
  • H20080111

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267305

Contacts
Contact: Lizhen Xuan, doctor 86-21-64041990 ext 2324 xuanlizhen@yahoo.cn

Locations
China
Zhongshan Hospital Recruiting
Shanghai, China, 200032
Contact: Lizhen Xuan     86-21-64041990 ext 2324     xuanlizhen@yahoo.cn    
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Principal Investigator: Lizhen Xuan Shanghai Zhongshan Hospital
  More Information

No publications provided

Responsible Party: Ming Zhong, department of anesthesiology and surgical intensive care unit, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01267305     History of Changes
Other Study ID Numbers: SICUTEG-01
Study First Received: December 25, 2010
Last Updated: December 2, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shanghai Zhongshan Hospital:
esophagectomy
lung resection
venous thromboembolism
 low molecular weight heparin
chest drainage
TEG

Additional relevant MeSH terms:
Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Hemorrhage
Lung Neoplasms
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Pathologic Processes
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Fondaparinux
PENTA
Anticoagulants
Heparin, Low-Molecular-Weight
Nadroparin
Calcium, Dietary
Hematologic Agents

ClinicalTrials.gov processed this record on June 17, 2013