Lung NeoplasmsNCT01267305
The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery
A study testing Fondaparinux and Nadroparin Calcium in people with Lung Neoplasms and Esophageal Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Esophageal Neoplasms, Venous Thromboembolism
- What is being tested?
- Fondaparinux and Nadroparin Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- blood clotting disfunction before surgery
- anticoagulating or antiplatelet history before surgery
- low blood platelets count
- hemorrhagic disease
- cerebral hemorrhage
- cerebral,spinal,ophthalmologic operation history
Show all 12Show fewer
- peptic ulcer
- bleeding>400ml in operation
- bleeding>100ml/h after operation
- blood transfusion in or after operation
- severe renal or liver disfunction
- severe hypertension
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Neoplasms, Esophageal Neoplasms, Venous Thromboembolism
- Being tested
- Fondaparinux, Nadroparin Calcium
- Keywords
- esophagectomy, lung resection, venous thromboembolism, low molecular weight heparin, chest drainage, TEG
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FondaparinuxDrug
Also called ARIXTRA, H20080111
2.5mg IH qd(8AM) after operation
Nadroparin CalciumDrug
Also called Fraxiparine
4100AxaIU IH qd(8AM) after operation
Nadroparin CalciumDrug
Also called Fraxiparine
4100AxaIU IH q12h(8Am,8Pm) after operation
| Study group | Role | What they receive |
|---|---|---|
| lung lmwh1 | Active comparator | use LMWH once daily after lung resection Receives: Drug: Nadroparin Calcium |
| lung lmwh2 | Experimental | use LMWH twice daily after lung resection Receives: Drug: Nadroparin Calcium |
| lung Fondaparinux | Experimental | use Fondaparinux once daily after lung resection Receives: Drug: Fondaparinux |
| eso lmwh1 | Active comparator | use LMWH once daily after esophagectomy Receives: Drug: Nadroparin Calcium |
| eso lmwh2 | Experimental | use LMWH twice daily after esophagectomy Receives: Drug: Nadroparin Calcium |
| eso Fondaparinux | Experimental | use Fondaparinux once daily after esophagectomy Receives: Drug: Fondaparinux |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three days after surgery
Secondary outcomes (3)
bleeding quantity of chest drainage
all drain from chest tube are gathered and hematocrits are measured to calculate the quantities of bleeding
Measured: three days after surgery
incidence rate of deep venous thromboembolism（DVT)
incidence of DVT is measured by vascular ultrasonography
Measured: after surgery up to 7 days
inhospital mortality
the number of death in the period of hospital stay
Measured: after surgery up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhong, Shanghai Zhongshan Hospital
- Investigators
- Lizhen Xuan, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267305
- Sponsor's protocol ID
- SICUTEG-01
- Status last verified
- Apr 2014
- First submitted
- 25 Dec 2010
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01267305
- Acronym / sponsor ID
- SICUTEG-01
- Conditions
- Lung Neoplasms, Esophageal Neoplasms, Venous Thromboembolism
- Keywords
- esophagectomy, lung resection, venous thromboembolism, low molecular weight heparin, chest drainage, TEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| lung lmwh1 | Active comparator | Drug: Nadroparin Calciumuse LMWH once daily after lung resection |
| lung lmwh2 | Experimental | Drug: Nadroparin Calciumuse LMWH twice daily after lung resection |
| lung Fondaparinux | Experimental | Drug: Fondaparinuxuse Fondaparinux once daily after lung resection |
| eso lmwh1 | Active comparator | Drug: Nadroparin Calciumuse LMWH once daily after esophagectomy |
| eso lmwh2 | Experimental | Drug: Nadroparin Calciumuse LMWH twice daily after esophagectomy |
| eso Fondaparinux | Experimental | Drug: Fondaparinuxuse Fondaparinux once daily after esophagectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- blood clotting disfunction before surgery
- anticoagulating or antiplatelet history before surgery
- low blood platelets count
- hemorrhagic disease
- cerebral hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FondaparinuxAlso: ARIXTRA, H200801112.5mg IH qd(8AM) after operation | Drug | eso Fondaparinux, lung Fondaparinux |
| Nadroparin CalciumAlso: Fraxiparine4100AxaIU IH qd(8AM) after operation | Drug | eso lmwh1, lung lmwh1 |
| Nadroparin CalciumAlso: Fraxiparine4100AxaIU IH q12h(8Am,8Pm) after operation | Drug | eso lmwh2, lung lmwh2 |
Primary outcome
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
3 secondary outcomes
bleeding quantity of chest drainage
Time frame: three days after surgery
incidence rate of deep venous thromboembolism（DVT)
Time frame: after surgery up to 7 days
inhospital mortality
Time frame: after surgery up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lizhen Xuan principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fondaparinux and Nadroparin Calcium in people with Lung Neoplasms and Esophageal Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEG values (time frame: three days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.