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

Zhejiang University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Metastasis Spinal Tumor

Treatments: Drug: stroke-physiological saline solution (SPSS); Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06023212

2022_LHY

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 10 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

tranexamic acid group

Experimental group

Description:

injection of 2 bottles of tranexamic acid (1g/bottle) before making incision; tranexamic acid soaked gauze applied to the wound before closing the wound; Intravenous injection of tranexamic acid 3 times (every 8 hours）within 24 hours after operation；

Treatment:

Drug: Tranexamic Acid

SPSS group

Placebo Comparator group

Description:

injection of 2 bottles of stroke-physiological saline solution（SPSS）before making incision; SPSS soaked gauze applied to the wound before closing the wound; Intravenous injection of SPSS 3 times (every 8 hours）within 24 hours after operation；

Treatment:

Drug: stroke-physiological saline solution (SPSS)