ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03011866
Date of registration:	16/12/2016
Prospective Registration:	Yes
Primary sponsor:	Peking Union Medical College Hospital
Public title:	Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries TARGETS
Scientific 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
Date of first enrolment:	February 2017
Target sample size:	176
Recruitment status:	Not yet recruiting
URL:	https://clinicaltrials.gov/show/NCT03011866
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment

Contacts

Name:	Qianyu Zhuang, M.D.
Address:
Telephone:	86-13552869326
Email:	zhuangqianyu@pumch.cn
Affiliation:

Key inclusion & exclusion criteria

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.

Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intervertebral Disc Displacement

Spinal Stenosis

Intervention(s)

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

Drug: Wound topically irrigated with 500mg TXA

Primary Outcome(s)

Perioperative Total blood loss (TBL) [Time Frame: Since operation initiation till postoperative day 3 (POD3)]

Secondary Outcome(s)

Length of hospital stay [Time Frame: A single inpatient duration since the day of admission till the day of discharge, an average of 1 week]

Perioperative transfusion amounts [Time Frame: Since operation initiation till postoperative 48hrs]

Postoperative activated partial thromboplastin time(APTT) [Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs]

Postoperative international normalized ratio(INR) [Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs]

Postoperative fibrinogen level(Fbg) [Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs]

Postoperative hidden blood loss (HBL) [Time Frame: 48hrs postoperatively]

Postoperative R time [Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.]

Combined visible perioperative blood loss [Time Frame: Since operation initiation till postoperative 48hrs]

Total postoperative blood loss [Time Frame: 0- 48hrs postoperatively]

Adverse event rates [Time Frame: Since operation initiation till postoperative 48hrs]

Postoperative K time [Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.]

Visible postoperative blood loss within 48hrs [Time Frame: 0- 48hrs postoperatively]

Postoperative lysis after 30 minutes(LY 30) [Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.]

Perioperative transfusion rates [Time Frame: Since operation initiation till postoperative 48hrs]

Visible intraoperative blood loss [Time Frame: Since operation initiation till operation completion, an average of 120min]

Postoperative maximum amplitude (MA) [Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.]

Visible postoperative blood loss within 24hrs [Time Frame: 0- 24hrs postoperatively]

Postoperative hemoglobin nadir [Time Frame: Since operation completion till postoperative 48hrs]

Postoperative prothrombin time(PT) [Time Frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs]

Secondary ID(s)

PUMCH-000391

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.