Clinical trial NCT02940444: Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery
Official title: Safety and Efficacy of Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Thromboprophylaxis
Thoracic Surgery
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: intraoperative bleeding volume (ml)
timeFrame: the bleeding volume (ml) during operation in the operation room for all patients
measure: chest tube drainage volume (ml)
timeFrame: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy )
measure: thromboembolism occurence rate (%)
timeFrame: within 30 days after surgery
measure: APTT (s)
timeFrame: on postoperative day 1 for both group
measure: PT(s)
timeFrame: on postoperative day 1 for both group
measure: INR
timeFrame: on postoperative day 1 for both group
measure: blood platlet count(/L)
timeFrame: on postoperative day 1 for both group
measure: chest tube drainage duration (days)
timeFrame: 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:
measure: PT(s)
timeFrame: rightly upon hospital admission day
measure: APTT(s)
timeFrame: rightly upon hospital admission day
measure: INR
timeFrame: rightly upon hospital admission day
measure: blood platlet count(/L)
timeFrame: rightly upon hospital admission day
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of thoracic surgery, west china hospital, sichuan university
state: Sichuan
Study officials:
References:
citation: Deng HY, Shi CL, Li G, Luo J, Wang ZQ, Lin YD, Liu LX, Zhou QH. The safety profile of preoperative administration of heparin for thromboprophylaxis in Chinese patients intended for thoracoscopic major thoracic surgery: a pilot randomized controlled study. J Thorac Dis. 2017 Apr;9(4):1065-1072. doi: 10.21037/jtd.2017.03.148.