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Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients

Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients: a Triple Blinded, Randomized Controlled Trial to Assess the Efficacy of Tranexamic Acid for Hemostasis

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06023212
Enrollment
150
Registered
2023-09-05
Start date
2023-12-01
Completion date
2026-08-01
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasis Spinal Tumor

Keywords

Tranexamic Acid, blood loss, seperation surgery

Brief summary

Massive blood loss occurs in metastatic spinal tumor resection and may cause severe complications. The objective of this study is to investigate whether the use of tranexamic acid will reduce perioperative and postoperative bleeding when compared to those without use of tranexamic acid.

Interventions

DRUGTranexamic Acid

IV drip of 2 bottles of tranexamic acid (2g) before making incision during surgery; 1g tranexamic acid soaked gauze applied to the wound for 5 minintes before suture; patients were administered IV drip of tranexamic acid 3 times (every 8 hours)within 24 hours after surgery.

DRUGstroke-physiological saline solution (SPSS)

IV drip of 2 bottles of saline before making incision during surgery; saline soaked gauze applied to the wound for 5 minintes before suture; patients were administered IV drip of saline 3 times (every 8 hours)within 24 hours after surgery.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed as metastatic carcinoma of the thoracolumbar spine * solitary neoplasm involve only one segment of spine * patients underwent separation surgery

Exclusion criteria

* coagulation function was abnormal preoperatively * patients are allergic to tranexamic acid * neoplasm involve more than one segment of spine * patients with rich blood supply who need embolization

Design outcomes

Primary

MeasureTime frameDescription
total blood lossmeasured 3 days postoperativelythe loss of total blood volume caused by various operations (mainly during surgical operations) throughout the entire treatment process. Total blood volume = preoperative blood volume \*(preoperative hematocrit - hematocrit 3 days postoperatively)
Intraoperative blood loss1 day (measured once after surgery)Refers to the total blood loss of a patient experienced during operation from skin incision to wound suture. Intraoperative blood loss = intraoperative drainage volume - intraoperative flushing volume + blood loss estimation using gauze (calculated as 10 cm × 10 cm gauze absorbs 10 ml)

Secondary

MeasureTime frameDescription
allogeneic transfusion blood volume1 day (measured once during surgery)amount of allogeneic transfusion blood volume needed during operation

Countries

China

Contacts

Primary ContactHengyuan Li, MD
hengyuanxiang007@163.com13616519278

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026