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Status unknownNCT02940444Updated Oct 24, 2016

Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery

A Phase 1/2 interventional study of Heparin in Thromboprophylaxis and Thoracic Surgery, sponsored by West China Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-24.

Sponsored by West China Hospital · Phase 1/2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Thromboprophylaxis
  • Thoracic Surgery

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03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 84 across 198 interventional studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-75 years old without any preoperative VTEs;
  • patients undergoing major thoracic surgery (including lobectomy, esophagectomy, and thymectomy).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    case group

    start heparin sodium (5000IU, BID) upon admission, and continue until discharge

    Drug: Heparin

  • Active comparator
    control group

    start heparin sodium (5000 IU,BID) from postoperative day 1, and continue until discharge

    Drug: Heparin

Interventions

  • DrugHeparin
06

What researchers measure

Primary outcomes

  1. intraoperative bleeding volume (ml)

    During the operation, the blood loss of each patient was collected and measured, and recorded by the investigators.

    Time frame: the bleeding volume (ml) during operation in the operation room for all patients

  2. 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 )

  3. thromboembolism occurence rate (%)

    Time frame: within 30 days after surgery

  4. APTT (s)

    Time frame: on postoperative day 1 for both group

  5. PT(s)

    Time frame: on postoperative day 1 for both group

  6. INR

    Time frame: on postoperative day 1 for both group

  7. blood platlet count(/L)

    Time frame: on postoperative day 1 for both group

  8. 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 )

Secondary outcomes

  1. PT(s)

    Time frame: rightly upon hospital admission day

  2. APTT(s)

    Time frame: rightly upon hospital admission day

  3. INR

    Time frame: rightly upon hospital admission day

  4. blood platlet count(/L)

    Time frame: rightly upon hospital admission day

07

Study locations

1 of 1 sites recruiting
  • Department of thoracic surgery, west china hospital, sichuan university
    Chengdu, Sichuan 610041, China
    • Han-Yu Deng, MD · Contact · 907151184@qq.com · +86 18200295920
    • Yi-Dan Lin, MD · Principal investigator
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02940444
Lead sponsor
West China Hospital
Responsible party
Yi-Dan Lin (proffessor, West China Hospital) — Principal investigator
First posted
Oct 21, 2016
Start date
Jun 2016
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Oct 24, 2016

Study contacts

Yi-Dan Lin, MD
Contact
hanyudeng@stu.scu.edu.cn
+86 18980602136
Han-Yu Deng, MD
Contact
907151184@qq.com
+86 18200295920

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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