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Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery

Phase 1
Conditions
Thromboprophylaxis
Thoracic Surgery
Interventions
Registration Number
NCT02940444
Lead Sponsor
West China Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
2000
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
control groupHeparinstart heparin sodium (5000 IU,BID) from postoperative day 1, and continue until discharge
case groupHeparinstart heparin sodium (5000IU, BID) upon admission, and continue until discharge
Primary Outcome Measures
NameTimeMethod
INRon postoperative day 1 for both group
blood platlet count(/L)on postoperative day 1 for both group
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 )
APTT (s)on postoperative day 1 for both group
intraoperative bleeding volume (ml)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.

PT(s)on postoperative day 1 for both group
thromboembolism occurence rate (%)within 30 days after surgery
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 Outcome Measures
NameTimeMethod
APTT(s)rightly upon hospital admission day
PT(s)rightly upon hospital admission day
INRrightly upon hospital admission day
blood platlet count(/L)rightly upon hospital admission day

Trial Locations

Locations (1)

Department of thoracic surgery, west china hospital, sichuan university

🇨🇳

Chengdu, Sichuan, China

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