Safety and Efficacy of Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery
Overview
- Phase
- Phase 1
- Intervention
- Heparin
- Conditions
- Thromboprophylaxis
- Sponsor
- West China Hospital
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- INR
- Last Updated
- 9 years ago
Overview
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.
Investigators
Yi-Dan Lin
proffessor
West China Hospital
Eligibility Criteria
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.
Arms & Interventions
case group
start heparin sodium (5000IU, BID) upon admission, and continue until discharge
Intervention: Heparin
control group
start heparin sodium (5000 IU,BID) from postoperative day 1, and continue until discharge
Intervention: Heparin
Outcomes
Primary Outcomes
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 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 )
APTT (s)
Time Frame: on postoperative day 1 for both group
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.
PT(s)
Time Frame: on postoperative day 1 for both group
thromboembolism occurence rate (%)
Time Frame: within 30 days after surgery
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
- 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)