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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267305
• Other study ID #: SICUTEG-01
• Status: Completed
• Phase: N/A
• First received: December 25, 2010
• Last updated: April 28, 2014
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: April 2014
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Lung Neoplasms
• Neoplasms
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Fondaparinux
2.5mg IH qd(8AM) after operation
• Nadroparin Calcium
4100AxaIU IH qd(8AM) after operation
• Nadroparin Calcium
4100AxaIU IH q12h(8Am,8Pm) after operation

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	bleeding quantity of chest drainage	all drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding	three days after surgery	Yes
Secondary	incidence rate of deep venous thromboembolism(DVT)	incidence of DVT is measured by vascular ultrasonography	after surgery up to 7 days	Yes
Secondary	inhospital mortality	the number of death in the period of hospital stay	after surgery up to 28 days	Yes