Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery

Study Overview
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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.

Official Title
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Safety and Efficacy of Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery

Conditions
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Thromboprophylaxis, Thoracic Surgery

Intervention / Treatment
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* Drug: Heparin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: case group<br>start heparin sodium (5000IU, BID) upon admission, and continue until discharge | Drug: Heparin<br> <br> |
| Active Comparator: control group<br>start heparin sodium (5000 IU,BID) from postoperative day 1, and continue until discharge | Drug: Heparin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |