Blood Loss Following Open Femur Fracture SurgeryPhase 4NCT03679481
The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
A Phase 4 study testing Tranexamic acid (TXA) and Normal saline in people with Blood Loss Following Open Femur Fracture Surgery, run by The University of Texas Health Science Center, Houston.
Trial summary
The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss Following Open Femur Fracture Surgery
- What is being tested?
- Tranexamic acid (TXA) and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.
Who cannot join
- Preoperative use of any anticoagulant
- History of deep venous thrombosis or pulmonary embolus
- Allergy to TXA
- Hepatic dysfunction (AST/ALT > 60)
- Renal dysfunction (Cr > 1.5 or GFR < 30)
- History of cerebrovascular accident in the past 12 months
Show all 10Show fewer
- Active coronary artery disease (event in the past 12 months)
- Presence of drug-eluting stent
- Color blindness
- Presence of an additional acute injury that could contribute to blood transfusion requirements
About this study
The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.
- Being tested
- Tranexamic acid (TXA), Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA)Drug
Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
Normal salineDrug
Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid (TXA) | Experimental | Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline. Receives: Drug: Tranexamic acid (TXA) |
| Normal saline | Placebo comparator | Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion requirements as assessed by number of packed red blood cell units received
Measured: from the time of surgery to hospital discharge (about 3-5 days)
Secondary outcomes (4)
Surgical blood loss as assessed by change in red blood cell volume
Blood loss will be determined using the following calculations:
[Patient's Blood Volume (PBV) = (k1 x Height^3 (m)) + (k2 x Weight (kg)) + k3] (- k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men) (- k1 = 0.3561, k2=0.03308, and k3 = 0.1833 for women)
Multiplying the PBV by the hematocrit (Hct) gives the red blood cell (RBC) volume. As such, a change in the RBC volume can be calculated from a change in the Hct level as follows. PACU is post-anesthesia care unit: [Operative RBC volume loss = PBV x (Day of surgery Hct - PACU Hct)]
If a patient requires an intraoperative transfusion, the calculation will be adjusted as follows:
Operative RBC volume loss = [ [PBV x (Day of surgery Hct - PACU Hct)] +)] + (No. of Units Transfused x 0.285) / (Day of surgery Hct - Post-op Hct) / 2) ]
Measured: baseline, while in PACU (which is about 4-6 hours after surgery)
Surgical blood loss as assessed by an intraoperative cell salvage machine
The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss.
Measured: at the time of surgery
Length of hospital stay
Measured: from the time of hospital admission to the time of hospital discharge (about 5 days)
Number of participants with complications
Complications include infection, venous thromboembolic event, and mortality.
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Why it stopped: study not started due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss Following Open Femur Fracture SurgeryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Warner, The University of Texas Health Science Center, Houston
- Investigators
- Stephen J Warner, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679481
- Sponsor's protocol ID
- HSC-MS-17-0920
- Status last verified
- Oct 2019
- First submitted
- 24 Jul 2018
- Last updated
- 17 Oct 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
- ClinicalTrials.gov ID
- NCT03679481
- Acronym / sponsor ID
- HSC-MS-17-0920
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not started due to lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 20 Sep 2018 (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.
The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid (TXA) | Experimental | Drug: Tranexamic acid (TXA)Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline. |
| Normal saline | Placebo comparator | Drug: Normal salineFollowing induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.
Key exclusion criteria (10 listed)
- Preoperative use of any anticoagulant
- History of deep venous thrombosis or pulmonary embolus
- Allergy to TXA
- Hepatic dysfunction (AST/ALT > 60)
- Renal dysfunction (Cr > 1.5 or GFR < 30)
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 acid (TXA)Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline. | Drug | Tranexamic acid (TXA) |
| Normal salineFollowing induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline. | Drug | Normal saline |
Primary outcome
Transfusion requirements as assessed by number of packed red blood cell units received
Time frame: from the time of surgery to hospital discharge (about 3-5 days)
4 secondary outcomes
Surgical blood loss as assessed by change in red blood cell volume
Time frame: baseline, while in PACU (which is about 4-6 hours after surgery)
Surgical blood loss as assessed by an intraoperative cell salvage machine
Time frame: at the time of surgery
Length of hospital stay
Time frame: from the time of hospital admission to the time of hospital discharge (about 5 days)
Number of participants with complications
Time frame: 6 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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.
Stephen J Warner, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid (TXA) and Normal saline in people with Blood Loss Following Open Femur Fracture Surgery, run by The University of Texas Health Science Center, Houston.
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 1 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: withdrawn, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Transfusion requirements as assessed by number of packed red blood cell units received (time frame: from the time of surgery to hospital discharge (about 3-5 days)). 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 17 Oct 2019.