Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Spinal Stenosis Clinical Trial

— TARGETS  

Official title:

Intravenous Versus Topical Use of Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS) : A Prospective, Randomized, Double Blind, Head-to-head Comparison Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03011866
• Other study ID #: PUMCH-000391
• Status: Not yet recruiting
• Phase: N/A
• First received: December 16, 2016
• Last updated: January 4, 2017
• Start date: February 2017

Study information

• Verified date: January 2017
• Source: Peking Union Medical College Hospital
• Contact: Qianyu Zhuang, M.D.
• Phone: 86-13552869326
• Email: zhuangqianyu[@]pumch.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists(ASA)classification of physical status I-II.

• Aged over 50yrs.

• Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries.

• Written informed consent.

Exclusion Criteria:

• ASA III-IV.

• Age= 50yrs.

• History of chronic renal dysfunction (preoperative blood creatinine> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase> 50 units/L) or history of coronary artery disease with stent placement.

• Abnormal preoperative coagulation profile (preoperative prothrombin time elongation> 3s, activated partial thromboplastin time elongation> 10s, platelet counts< 100*10^9/L or >400*10^9/L, or INR> 1.4).

• Pre-existing anemia (male< 12g/dL, female<11g/dL).

• Long-term medications of aspirin and/or other anticoagulants.

• Patients known as allergic to TXA.

• Patients who have religious and/or other beliefs limiting blood transfusion.

• Dura mater laceration and/or unexpected massive bleeding during operation.

• Cell saver application during operation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Intervertebral Disc Displacement
• Spinal Stenosis

Intervention

Drug:
• Wound topically irrigated with 500mg TXA

• 1mg/kg/hr TXA intravenous infusion till the last suture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative Total blood loss (TBL)	TBL= PBV*(hematocrit on postoperative day 3- preoperative hematocrit)/average hematocrit; Predicted blood volume(PBV)= k1* height^3(m)+ k2* weight(kg)+ k3 (female: k1=0.3561, k2=0.03308, k3=0.1833, male: k1=0.3669, k2=0.03219, k3=0.6041)	Since operation initiation till postoperative day 3 (POD3)	No
Secondary	Visible intraoperative blood loss		Since operation initiation till operation completion, an average of 120min	No
Secondary	Visible postoperative blood loss within 24hrs		0- 24hrs postoperatively	No
Secondary	Visible postoperative blood loss within 48hrs		0- 48hrs postoperatively	No
Secondary	Combined visible perioperative blood loss	Combined visible perioperative blood loss= visible intraoperative blood loss + visible postoperative blood loss within 24hrs + visible postoperative blood loss within 48hrs	Since operation initiation till postoperative 48hrs	No
Secondary	Total postoperative blood loss	Total postoperative blood loss= drainage day1(ml)* drainage Hct day1(%)/blood Hct day1(%)+ drainage day2(ml)* drainage Hct day2(%)/blood Hct day2(%)	0- 48hrs postoperatively	No
Secondary	Postoperative hidden blood loss (HBL)	HBL=TBL- combined visible perioperative blood loss	48hrs postoperatively	No
Secondary	Postoperative prothrombin time(PT)		Tested at operation completion, postoperative 24hrs and postoperative 48hrs	No
Secondary	Postoperative activated partial thromboplastin time(APTT)		Tested at operation completion, postoperative 24hrs and postoperative 48hrs	No
Secondary	Postoperative fibrinogen level(Fbg)		Tested at operation completion, postoperative 24hrs and postoperative 48hrs	No
Secondary	Postoperative international normalized ratio(INR)		Tested at operation completion, postoperative 24hrs and postoperative 48hrs	No
Secondary	Postoperative R time		Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.	No
Secondary	Postoperative K time		Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.	No
Secondary	Postoperative maximum amplitude (MA)		Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.	No
Secondary	Postoperative lysis after 30 minutes(LY 30)		Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.	No
Secondary	Postoperative hemoglobin nadir		Since operation completion till postoperative 48hrs	No
Secondary	Perioperative transfusion rates		Since operation initiation till postoperative 48hrs	No
Secondary	Perioperative transfusion amounts		Since operation initiation till postoperative 48hrs	No
Secondary	Length of hospital stay	Length of hospital stay is calculated by subtracting day of admission from day of discharge.	A single inpatient duration since the day of admission till the day of discharge, an average of 1 week	No
Secondary	Adverse event rates	Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.	Since operation initiation till postoperative 48hrs	Yes