Pelvic MassEarly Phase 1NCT03128866
Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery
A Early Phase 1 study testing Hemipelvectomy and Tranexamic Acid in people with Pelvic Mass, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pelvic Mass
- What is being tested?
- Hemipelvectomy and Tranexamic Acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2017to 31 May 2028
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both pediatric and adult patients can be eligible to participate
- Cognitively impaired and non-English speakers can be eligible to participate.
- Both male and female patients must have a pelvic tumor and are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption
Who cannot join
- Patient with a history of genetic prothrombotic state
- Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis
- Patients with thrombosis of the planned site of resection will not be excluded if the thrombus is caused directly by tumor burden or outflow obstruction
- Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment
- Patients will not be eligible if they have a history of color vision defects
- Patients will not be eligible if they have a history of retinal vein or artery occlusion
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- Patients will not be eligible if they have a history of intracranial hemorrhage in past 6 months
- Patients will not be eligible if they have a history of hypersensitivity to tranexamic acid
- Patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73m2)
- Patients will not be eligible if they present or have a history of seizure disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss.
SECONDARY OBJECTIVES:
- To determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week.
II. To determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7.
III. To determine if use of tranexamic acid has an effect on complication, length of intensive care unit (ICU), and hospital stays.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TRANEXAMIC ACID): Patients receive tranexamic acid intravenously (IV) over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.
ARM II (NO TRANEXAMIC ACID): Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 7 days.
- Conditions
- Pelvic Mass
- Being tested
- Hemipelvectomy, Tranexamic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemipelvectomyProcedure or surgery
Undergo hemipelvectomy
Tranexamic AcidDrug
Also called Cyclokapron, Cyklokapron, Lysteda, Tranhexamic Acid
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (tranexamic acid) | Experimental | Patients receive tranexamic acid IV over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Hemipelvectomy; Drug: Tranexamic Acid |
| Arm II (no tranexamic acid) | Experimental | Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Hemipelvectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss
Intraoperative blood loss and perioperative blood loss (total of intraoperative EBL and 1 week drain) will be compared between two groups utilizing two-sample t-test or Wilcoxon rank-sum test. Log-transformation will be taken on the blood loss measurements as appropriate. Multivariable linear regression models will be used to compare two treatment groups in intraoperative and perioperative blood loss by adjusting for significant covariates. Model selection technique, including backward elimination, will be implemented.
Measured: During first post-operative week
Secondary outcomes (6)
Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of intense care unit (ICU), and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Measured: At the time of procedure
Total number of units of PRBCs, FFP, cryoprecipitate, and platelets
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Measured: During first post-operative week
Thromboelastography (TEG)
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Measured: At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure
Change in laboratory measurements
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Measured: Baseline up to 7 days post-surgery
Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding)
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Measured: Up to 7 days post-surgery
Length of ICU and hospital stay
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Measured: Up to 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start19 May 2017
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic MassStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Valerae O Lewis, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128866
- Sponsor's protocol ID
- 2016-0650
- Other IDs
- NCI-2018-01178, 2016-0650
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2017
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
- ClinicalTrials.gov ID
- NCT03128866
- Acronym / sponsor ID
- 2016-0650
- Conditions
- Pelvic Mass
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 25 Apr 2017 (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.
This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.
Detailed description
PRIMARY OBJECTIVES:
- To determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss.
SECONDARY OBJECTIVES:
- To determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week.
II. To determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7.
III. To determine if use of tranexamic acid has an effect on complication, length of intensive care unit (ICU), and hospital stays.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TRANEXAMIC ACID): Patients receive tranexamic acid intravenously (IV) over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.
ARM II (NO TRANEXAMIC ACID): Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 7 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (tranexamic acid) | Experimental | Procedure: Hemipelvectomy, Drug: Tranexamic AcidPatients receive tranexamic acid IV over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity. |
| Arm II (no tranexamic acid) | Experimental | Procedure: HemipelvectomyPatients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Both pediatric and adult patients can be eligible to participate
- Cognitively impaired and non-English speakers can be eligible to participate.
- Both male and female patients must have a pelvic tumor and are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption
Key exclusion criteria (10 listed)
- Patient with a history of genetic prothrombotic state
- Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis
- Patients with thrombosis of the planned site of resection will not be excluded if the thrombus is caused directly by tumor burden or outflow obstruction
- Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment
- Patients will not be eligible if they have a history of color vision defects
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 |
|---|---|---|
| HemipelvectomyUndergo hemipelvectomy | Procedure or surgery | Arm I (tranexamic acid), Arm II (no tranexamic acid) |
| Tranexamic AcidAlso: Cyclokapron, Cyklokapron, Lysteda, Tranhexamic AcidGiven IV | Drug | Arm I (tranexamic acid) |
Primary outcome
Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss
Time frame: During first post-operative week
Intraoperative blood loss and perioperative blood loss (total of intraoperative EBL and 1 week drain) will be compared between two groups utilizing two-sample t-test or Wilcoxon rank-sum test. Log-transformation will be taken on the blood loss measurements as appropriate. Multivariable linear regression models will be used to compare two treatment groups in intraoperative and perioperative blood loss by adjusting for significant covariates. Model selection technique, including backward elimination, will be implemented.
6 secondary outcomes
Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets
Time frame: At the time of procedure
Total number of units of PRBCs, FFP, cryoprecipitate, and platelets
Time frame: During first post-operative week
Thromboelastography (TEG)
Time frame: At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure
Change in laboratory measurements
Time frame: Baseline up to 7 days post-surgery
Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding)
Time frame: Up to 7 days post-surgery
Length of ICU and hospital stay
Time frame: Up to 7 days post-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 24 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Valerae O Lewis principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hemipelvectomy and Tranexamic Acid in people with Pelvic Mass, run by M.D. Anderson Cancer Center at 1 site in United States.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss (time frame: During first post-operative week). 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 24 Sep 2026.