Postoperative Blood LossPhase 2/3NCT05047133
Effect of Early Administration of TXA in Adult Hip Fractures
A Phase 2/3 study testing Tranexamic acid in people with Postoperative Blood Loss, run by Ascension Health at 1 site in United States.
Trial summary
This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Blood Loss
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Jul 2022
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation
Who cannot join
- Polytrauma patients
- Previous operation on the ipsilateral hip
- Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)
- Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)
- History of seizure disorder
- Patients on birth control
Show all 9Show fewer
- Pregnant Women
- Prisoners
- Active thromboembolic disease (DVT/PE, MI, Stroke)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ascension Genesys Hospital
Grand Blanc, Michigan, 48439
Sandra Watt, MS, BSN, 810-606-7713, sandra.watt@ascension.org
About this study
Official title: Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?
This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.
- Conditions
- Postoperative Blood Loss
- Being tested
- Tranexamic acid
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Lysteda
TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups
| Study group | Role | What they receive |
|---|---|---|
| Early Adminstration of TXA + Intraoperative TXA | Experimental | This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively. Receives: Drug: Tranexamic acid |
| Intraoperative only TXA | Other | This group will only receive the intraoperative TXA. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Blood Transfusion
Patient receives a blood transfusion during their postoperative stay in the hospital
Measured: Up to two weeks
Overall Blood Loss
Calculate the difference in postoperative blood loss between groups
Measured: Up to two weeks
Secondary outcomes (4)
Length of hospital stay
Overall length of hospital stay
Measured: Up to two weeks
Postoperative Pain
Difference in overall pain scores between groups
Measured: Up to two weeks
Wound complications
Acute wound complications documented after surgical intervention
Measured: Up to two weeks
Acute DVT/PE
Documented deep venous thrombosis or pulmonary embolism
Measured: Up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Blood LossStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jacob Hinkley, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047133
- Sponsor's protocol ID
- 1722787-1
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?
- ClinicalTrials.gov ID
- NCT05047133
- Acronym / sponsor ID
- 1722787-1
- Conditions
- Postoperative Blood Loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 16 Sep 2021 (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 is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Adminstration of TXA + Intraoperative TXA | Experimental | Drug: Tranexamic acidThis group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively. |
| Intraoperative only TXA | Other | Drug: Tranexamic acidThis group will only receive the intraoperative TXA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation
Key exclusion criteria (9 listed)
- Polytrauma patients
- Previous operation on the ipsilateral hip
- Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)
- Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)
- History of seizure disorder
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 acidAlso: LystedaTXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups | Drug | Early Adminstration of TXA + Intraoperative TXA, Intraoperative only TXA |
Primary outcome
Postoperative Blood Transfusion
Time frame: Up to two weeks
Patient receives a blood transfusion during their postoperative stay in the hospital
Overall Blood Loss
Time frame: Up to two weeks
Calculate the difference in postoperative blood loss between groups
4 secondary outcomes
Length of hospital stay
Time frame: Up to two weeks
Postoperative Pain
Time frame: Up to two weeks
Wound complications
Time frame: Up to two weeks
Acute DVT/PE
Time frame: Up to two weeks
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 16 Sep 2021.
- Individual participant dataSharing planned: No
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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 2/3 study testing Tranexamic acid in people with Postoperative Blood Loss, run by Ascension Health 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 1 inclusion and 9 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 16 Sep 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jacob Hinkley, DO, MS (810-606-5669, jacob.hinkley2@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Blood Transfusion (time frame: Up to two weeks). 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 16 Sep 2021.