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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01267305
Enrollment
362
Registered
2010-12-28
Start date
2011-01-31
Completion date
2013-08-31
Last updated
2014-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms, Esophageal Neoplasms, Venous Thromboembolism

Keywords

esophagectomy, lung resection, venous thromboembolism, low molecular weight heparin, chest drainage, TEG

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.

Interventions

DRUGFondaparinux

2.5mg IH qd(8AM) after operation

4100AxaIU IH qd(8AM) after operation

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TEG valuesthree days after surgery1.5ml 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

MeasureTime frameDescription
bleeding quantity of chest drainagethree days after surgeryall drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding
incidence rate of deep venous thromboembolism(DVT)after surgery up to 7 daysincidence of DVT is measured by vascular ultrasonography
inhospital mortalityafter surgery up to 28 daysthe number of death in the period of hospital stay

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026