Metastasis Spinal TumorPhase 1/2NCT06023212
Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients
A Phase 1/2 study testing Tranexamic Acid and stroke-physiological saline solution (SPSS) in people with Metastasis Spinal Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Metastasis Spinal Tumor
- What is being tested?
- Tranexamic Acid and stroke-physiological saline solution (SPSS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed as metastatic carcinoma of the thoracolumbar spine
- solitary neoplasm involve only one segment of spine
- patients underwent separation surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 311200
Hengyuan Li, MD, 13616519278, hengyuanxiang007@163.com
About this study
Official title: 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
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.
- Conditions
- Metastasis Spinal Tumor
- Being tested
- Tranexamic Acid, stroke-physiological saline solution (SPSS)
- Keywords
- Tranexamic Acid, blood loss, seperation surgery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
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.
stroke-physiological saline solution (SPSS)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid group | Experimental | 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； Receives: Drug: Tranexamic Acid |
| SPSS group | Placebo comparator | 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； Receives: Drug: stroke-physiological saline solution (SPSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
total blood loss
the 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）
Measured: measured 3 days postoperatively
Intraoperative blood loss
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)
Measured: 1 day (measured once after surgery)
Secondary outcomes (1)
allogeneic transfusion blood volume
amount of allogeneic transfusion blood volume needed during operation
Measured: 1 day (measured once during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Dec 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastasis Spinal TumorStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023212
- Sponsor's protocol ID
- 2022_LHY
- Status last verified
- Jan 2025
- First submitted
- 29 Aug 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06023212
- Acronym / sponsor ID
- 2022_LHY
- Conditions
- Metastasis Spinal Tumor
- Keywords
- Tranexamic Acid, blood loss, seperation surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid group | Experimental | Drug: Tranexamic Acidinjection 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； |
| SPSS group | Placebo comparator | Drug: stroke-physiological saline solution (SPSS)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； |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as metastatic carcinoma of the thoracolumbar spine
- solitary neoplasm involve only one segment of spine
- patients underwent separation surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidIV 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. | Drug | tranexamic acid group |
| stroke-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. | Drug | SPSS group |
Primary outcome
total blood loss
Time frame: measured 3 days postoperatively
the 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 loss
Time frame: 1 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)
1 secondary outcome
allogeneic transfusion blood volume
Time frame: 1 day (measured once during surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic Acid and stroke-physiological saline solution (SPSS) in people with Metastasis Spinal Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hengyuan Li, MD (13616519278, hengyuanxiang007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total blood loss (time frame: measured 3 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.