ThromboprophylaxisPhase 1/2NCT02940444
Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery
A Phase 1/2 study testing Heparin in people with Thromboprophylaxis and Thoracic Surgery, run by West China Hospital at 1 site in China.
Trial summary
Thromboembolism is an important perioperative complication in major thoracic surgery, even though current guidelines have recommended postoperative administration of heparin or LMWH for thromboprophylaxis for those high-risk patients, there are still many cases of thromboembolism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thromboprophylaxis, Thoracic Surgery
- What is being tested?
- Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2018
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old without any preoperative VTEs;
- patients undergoing major thoracic surgery (including lobectomy, esophagectomy, and thymectomy).
Who cannot join
- patients with coagulation disorders: preoperative international normalized ratio (INR) > 1.5, or blood platelet count < 50x10^9/L;
- patients receiving any therapeutic anticoagulation preoperatively;
- patients with severe renal or liver dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of thoracic surgery, west china hospital, sichuan university
Chengdu, Sichuan, 610041
Han-Yu Deng, MD, +86 18200295920, 907151184@qq.com
Yi-Dan Lin, MD
About this study
Official title: Safety and Efficacy of Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery
Thromboembolism is an important perioperative complication in major thoracic surgery, even though current guidelines have recommended postoperative administration of heparin or LMWH for thromboprophylaxis for those high-risk patients, there are still many cases of thromboembolism. Therefore, as the guideline itself writes, the investigators believe the rational of dose and timing of heparin in thoracic surgery are still not well established. Therefore, the investigators aimed to conduct this randomized controlled study to explore the safety and efficacy of preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery.
- Conditions
- Thromboprophylaxis, Thoracic Surgery
- Being tested
- Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | start heparin sodium (5000IU, BID) upon admission, and continue until discharge Receives: Drug: Heparin |
| control group | Active comparator | start heparin sodium (5000 IU,BID) from postoperative day 1, and continue until discharge Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative bleeding volume (ml)
During the operation, the blood loss of each patient was collected and measured, and recorded by the investigators.
Measured: the bleeding volume (ml) during operation in the operation room for all patients
chest tube drainage volume (ml)
Measured: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy )
thromboembolism occurence rate (%)
Measured: within 30 days after surgery
APTT (s)
Measured: on postoperative day 1 for both group
PT(s)
Measured: on postoperative day 1 for both group
INR
Measured: on postoperative day 1 for both group
blood platlet count(/L)
Measured: on postoperative day 1 for both group
chest tube drainage duration (days)
Measured: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy )
Secondary outcomes (4)
PT(s)
Measured: rightly upon hospital admission day
APTT(s)
Measured: rightly upon hospital admission day
INR
Measured: rightly upon hospital admission day
blood platlet count(/L)
Measured: rightly upon hospital admission day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboprophylaxisStudies of the same condition, open and under way.
- More trials run by West China 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Dan Lin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940444
- Sponsor's protocol ID
- WCH-20160601
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Deng HY, Shi CL, Li G, Luo J, Wang ZQ, Lin YD, Liu LX, Zhou QH. The safety profile of preoperative administration of heparin for thromboprophylaxis in Chinese patients intended for thoracoscopic major thoracic surgery: a pilot randomized controlled study. J Thorac Dis. 2017 Apr;9(4):1065-1072. doi: 10.21037/jtd.2017.03.148.
PubMed 28523161
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02940444
- Acronym / sponsor ID
- WCH-20160601
- Conditions
- Thromboprophylaxis, Thoracic Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Oct 2016 (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.
Thromboembolism is an important perioperative complication in major thoracic surgery, even though current guidelines have recommended postoperative administration of heparin or LMWH for thromboprophylaxis for those high-risk patients, there are still many cases of thromboembolism. Therefore, as the guideline itself writes, the investigators believe the rational of dose and timing of heparin in thoracic surgery are still not well established. Therefore, the investigators aimed to conduct this randomized controlled study to explore the safety and efficacy of preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Drug: Heparinstart heparin sodium (5000IU, BID) upon admission, and continue until discharge |
| control group | Active comparator | Drug: Heparinstart heparin sodium (5000 IU,BID) from postoperative day 1, and continue until discharge |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-75 years old without any preoperative VTEs;
- patients undergoing major thoracic surgery (including lobectomy, esophagectomy, and thymectomy).
Key exclusion criteria (3 listed)
- patients with coagulation disorders: preoperative international normalized ratio (INR) > 1.5, or blood platelet count < 50x10^9/L;
- patients receiving any therapeutic anticoagulation preoperatively;
- patients with severe renal or liver dysfunction.
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 |
|---|---|---|
| Heparin | Drug | case group, control group |
Primary outcome
intraoperative bleeding volume (ml)
Time frame: the bleeding volume (ml) during operation in the operation room for all patients
During the operation, the blood loss of each patient was collected and measured, and recorded by the investigators.
chest tube drainage volume (ml)
Time frame: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy )
thromboembolism occurence rate (%)
Time frame: within 30 days after surgery
APTT (s)
Time frame: on postoperative day 1 for both group
PT(s)
Time frame: on postoperative day 1 for both group
INR
Time frame: on postoperative day 1 for both group
blood platlet count(/L)
Time frame: on postoperative day 1 for both group
chest tube drainage duration (days)
Time frame: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy )
4 secondary outcomes
PT(s)
Time frame: rightly upon hospital admission day
APTT(s)
Time frame: rightly upon hospital admission day
INR
Time frame: rightly upon hospital admission day
blood platlet count(/L)
Time frame: rightly upon hospital admission day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Derived from this study: PubMed 28523161Deng HY, Shi CL, Li G, Luo J, Wang ZQ, Lin YD, Liu LX, Zhou QH. The safety profile of preoperative administration of heparin for thromboprophylaxis in Chinese patients intended for thoracoscopic major thoracic surgery: a pilot randomized controlled study. J Thorac Dis. 2017 Apr;9(4):1065-1072. doi: 10.21037/jtd.2017.03.148.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Heparin in people with Thromboprophylaxis and Thoracic Surgery, run by West China 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Oct 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Dan Lin, MD (+86 18980602136, hanyudeng@stu.scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative bleeding volume (ml) (time frame: the bleeding volume (ml) during operation in the operation room for all patients). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02940444, which also lists 1 linked publication.
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 24 Oct 2016.