Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery

NCT ID: NCT02940444

Last Updated: 2016-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thromboprophylaxis Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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case group

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

Group Type EXPERIMENTAL

Heparin

Intervention Type DRUG

control group

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

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

Interventions

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Heparin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi-Dan Lin

proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of thoracic surgery, west china hospital, sichuan university

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi-Dan Lin, MD

Role: CONTACT

+86 18980602136

Han-Yu Deng, MD

Role: CONTACT

+86 18200295920

Facility Contacts

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Han-Yu Deng, MD

Role: primary

+86 18200295920

References

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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.

Reference Type DERIVED
PMID: 28523161 (View on PubMed)

Other Identifiers

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WCH-20160601

Identifier Type: -

Identifier Source: org_study_id

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