NCT02940444

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 17, 2016

Last Update Submit

October 21, 2016

Conditions

ThromboprophylaxisThoracic Surgery

Outcome Measures

Primary Outcomes (8)

  • intraoperative bleeding volume (ml)

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

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

  • chest tube drainage volume (ml)

    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 (%)

    within 30 days after surgery

  • APTT (s)

    on postoperative day 1 for both group

  • PT(s)

    on postoperative day 1 for both group

  • INR

    on postoperative day 1 for both group

  • blood platlet count(/L)

    on postoperative day 1 for both group

  • chest tube drainage duration (days)

    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)

    rightly upon hospital admission day

  • APTT(s)

    rightly upon hospital admission day

  • INR

    rightly upon hospital admission day

  • blood platlet count(/L)

    rightly upon hospital admission day

Study Arms (2)

case group

EXPERIMENTAL

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

Drug: Heparin

control group

ACTIVE COMPARATOR

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

Drug: Heparin

Interventions

HeparinDRUG
case groupcontrol group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of thoracic surgery, west china hospital, sichuan university

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28523161DERIVED

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Yi-Dan Lin, MD

CONTACT

+86 18980602136hanyudeng@stu.scu.edu.cn

Han-Yu Deng, MD

CONTACT

+86 18200295920907151184@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
proffessor

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 21, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 24, 2016

Record last verified: 2016-10

Locations

CN(1)