The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery
1 other identifier
interventional
362
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2010
CompletedFirst Posted
Study publicly available on registry
December 28, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedApril 29, 2014
April 1, 2014
2.2 years
December 25, 2010
April 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
three days after surgery
Secondary Outcomes (3)
bleeding quantity of chest drainage
three days after surgery
incidence rate of deep venous thromboembolism（DVT)
after surgery up to 7 days
inhospital mortality
after surgery up to 28 days
Study Arms (6)
lung lmwh1
ACTIVE COMPARATORuse LMWH once daily after lung resection
lung lmwh2
EXPERIMENTALuse LMWH twice daily after lung resection
lung Fondaparinux
EXPERIMENTALuse Fondaparinux once daily after lung resection
eso lmwh1
ACTIVE COMPARATORuse LMWH once daily after esophagectomy
eso lmwh2
EXPERIMENTALuse LMWH twice daily after esophagectomy
eso Fondaparinux
EXPERIMENTALuse Fondaparinux once daily after esophagectomy
Interventions
2.5mg IH qd(8AM) after operation
4100AxaIU IH qd(8AM) after operation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital
Shanghai, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lizhen Xuan
Shanghai Zhongshan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- department of anesthesiology and surgical intensive care unit
Study Record Dates
First Submitted
December 25, 2010
First Posted
December 28, 2010
Study Start
January 1, 2011
Primary Completion
April 1, 2013
Study Completion
August 1, 2013
Last Updated
April 29, 2014
Record last verified: 2014-04