CClinicalTrials.gg
Sign In
CompletedNCT01267305Updated Apr 29, 2014

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

An interventional study of Fondaparinux and Nadroparin Calcium in Lung Neoplasms, Esophageal Neoplasms and Venous Thromboembolism, sponsored by Shanghai Zhongshan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-29.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
362
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Neoplasms
  • Esophageal Neoplasms
  • Venous Thromboembolism

Keywords

  • esophagectomy
  • lung resection
  • venous thromboembolism
  • low molecular weight heparin
  • chest drainage
  • TEG
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 362 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
362 participants (actual)

Study arms

  • Active comparator
    lung lmwh1

    use LMWH once daily after lung resection

    Drug: Nadroparin Calcium

  • Experimental
    lung lmwh2

    use LMWH twice daily after lung resection

    Drug: Nadroparin Calcium

  • Experimental
    lung Fondaparinux

    use Fondaparinux once daily after lung resection

    Drug: Fondaparinux

  • Active comparator
    eso lmwh1

    use LMWH once daily after esophagectomy

    Drug: Nadroparin Calcium

  • Experimental
    eso lmwh2

    use LMWH twice daily after esophagectomy

    Drug: Nadroparin Calcium

  • Experimental
    eso Fondaparinux

    use Fondaparinux once daily after esophagectomy

    Drug: Fondaparinux

Interventions

  • DrugFondaparinux

    2.5mg IH qd(8AM) after operation

    Also known as: ARIXTRA, H20080111

  • DrugNadroparin Calcium

    4100AxaIU IH qd(8AM) after operation

    Also known as: Fraxiparine

  • DrugNadroparin Calcium

    4100AxaIU IH q12h(8Am,8Pm) after operation

    Also known as: Fraxiparine

06

What researchers measure

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

    Time frame: three days after surgery

Secondary outcomes

  1. bleeding quantity of chest drainage

    all drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding

    Time frame: three days after surgery

  2. incidence rate of deep venous thromboembolism（DVT)

    incidence of DVT is measured by vascular ultrasonography

    Time frame: after surgery up to 7 days

  3. inhospital mortality

    the number of death in the period of hospital stay

    Time frame: after surgery up to 28 days

07

Study locations

1 site
  • Zhongshan Hospital
    Shanghai, 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01267305
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Ming Zhong (department of anesthesiology and surgical intensive care unit, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Dec 28, 2010
Start date
Jan 2011
Primary completion
Apr 2013
Completion
Aug 2013
Last update
Apr 29, 2014

Study contacts

Lizhen Xuan
principal investigator · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Shanghai Zhongshan Hospital

Start the discussion