Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940444
• Other study ID #: WCH-20160601
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 17, 2016
• Last updated: October 21, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2016
• Source: West China Hospital
• Contact: Yi-Dan Lin, MD
• Phone: +86 18980602136
• Email: hanyudeng[@]stu.scu.edu.cn
• Is FDA regulated: No
• Health authority: China: west china hospital, sichuan university
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thoracic Surgery
• Thromboprophylaxis

Intervention

Drug:
• Heparin

Locations

Country	Name	City	State
China	Department of thoracic surgery, west china hospital, sichuan university	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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 )	Yes
Primary	thromboembolism occurence rate (%)		within 30 days after surgery	No
Primary	APTT (s)		on postoperative day 1 for both group	No
Primary	PT(s)		on postoperative day 1 for both group	No
Primary	INR		on postoperative day 1 for both group	No
Primary	blood platlet count(/L)		on postoperative day 1 for both group	No
Primary	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 )	Yes
Secondary	PT(s)		rightly upon hospital admission day	No
Secondary	APTT(s)		rightly upon hospital admission day	No
Secondary	INR		rightly upon hospital admission day	No
Secondary	blood platlet count(/L)		rightly upon hospital admission day	No