- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267305
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
Status
Completed
Intervention / Treatment
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:
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
|
Experimental: lung lmwh2
use LMWH twice daily after lung resection
|
4100AxaIU IH qd(8AM) after operation
Other Names:
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
|
Experimental: lung Fondaparinux
use Fondaparinux once daily after lung resection
|
2.5mg IH qd(8AM) after operation
Other Names:
|
Active Comparator: eso lmwh1
use LMWH once daily after esophagectomy
|
4100AxaIU IH qd(8AM) after operation
Other Names:
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
|
Experimental: eso lmwh2
use LMWH twice daily after esophagectomy
|
4100AxaIU IH qd(8AM) after operation
Other Names:
4100AxaIU IH q12h(8Am,8Pm) after operation
Other Names:
|
Experimental: eso Fondaparinux
use Fondaparinux once daily after esophagectomy
|
2.5mg IH qd(8AM) after operation
Other Names:
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Head and Neck Neoplasms
- Embolism and Thrombosis
- Esophageal Diseases
- Neoplasms
- Lung Neoplasms
- Hemorrhage
- Thromboembolism
- Venous Thromboembolism
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Calcium
- Calcium, Dietary
- Fondaparinux
- PENTA
- Nadroparin
Other Study ID Numbers
- SICUTEG-01
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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