Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery

Sichuan University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Thromboprophylaxis; Thoracic Surgery

Treatments: Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02940444

WCH-20160601

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

case group

Experimental group

Description:

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

Treatment:

Drug: Heparin

control group

Active Comparator group

Description:

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

Treatment:

Drug: Heparin