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Completed

NCT Number: NCT01267305

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

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.

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Key information

Conditions

Lung Neoplasms Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fondaparinux

Drug

2.5mg IH qd(8AM) after operation

Other names: ARIXTRA, H20080111

Nadroparin calcium

Drug

4100AxaIU IH qd(8AM) after operation

Other names: Fraxiparine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. incidence rate of deep venous thromboembolism（DVT)

    Time frame: after surgery up to 7 days

    incidence of DVT is measured by vascular ultrasonography

  3. inhospital mortality

    Time frame: after surgery up to 28 days

    the number of death in the period of hospital stay

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 28, 2010
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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