Hip FractureNCT02738073
Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture
A study testing Tranexamic Acid in people with Hip Fracture, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Feb 2017
- Phase
- Interventional
- 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 Bryn Mawr Hospital with fracture of the femoral neck, intertrochanteric region, or subtrochanteric region of the femur will be considered for the study.
Who cannot join
- age under 18
- allergy to TA
- known current or history of venous thromboembolism (VTE)
- history of known coagulopathy or bleeding disorder
- current subarachnoid hemorrhage
- previous history of seizures
Show all 11Show fewer
- current use of estrogen/progesterone therapy
- renal failure defined as creatinine clearance less than 30 ml/min4
- multiple fractures
- pregnant or breastfeeding women
- planned nonoperative management of the fracture
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
About this study
Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and knee arthroplasty patients. Both the timing and dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has also been shown to decrease as result of TA administration. Despite the support for TA utilization that exists in the arthroplasty literature, the data is scarce regarding its administration during surgical treatment of hip fractures. This is patient population who is at high risk for transfusion due to symptomatic post-operative anemia. This study aims to investigate whether TA's advantageous effects in the arthroplasty patient population can be extrapolated to the more unstable, heterogeneous hip fracture patient population. If the study is able to show a difference in blood loss and transfusion requirement, the long term implications of this with regards to cost and mortality can be significant.
- Conditions
- Hip Fracture
- Being tested
- Control: Saline, Tranexamic Acid
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control: SalineDrug
Tranexamic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Control: Saline |
| Interventional | Active comparator | Not described Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
calculation of blood loss during the perioperative period
This study aims to investigate the effect of tranexamic acid (TA) on blood loss and transfusion requirement during the perioperative period in patients who are admitted to the hospital with fracture of the hip and undergo surgical treatment. Both the drop in hemoglobin level from time of surgery (T0 being defined as just prior to surgery, while the patient waits in surgical holding area) over the subsequent several days, as well as post-operative transfusion rate, will be measured. The researchers' hypothesis is that both the hemoglobin drop and the subsequent transfusion requirement in patients who receive TA will be less than those who received saline placebo.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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 N/A
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738073
- Sponsor's protocol ID
- 14RGOOD01
- Status last verified
- Apr 2016
- First submitted
- 10 Feb 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture
- ClinicalTrials.gov ID
- NCT02738073
- Acronym / sponsor ID
- 14RGOOD01
- Conditions
- Hip Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Primary completion
- Feb 2017 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- 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.
Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and knee arthroplasty patients. Both the timing and dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has also been shown to decrease as result of TA administration. Despite the support for TA utilization that exists in the arthroplasty literature, the data is scarce regarding its administration during surgical treatment of hip fractures. This is patient population who is at high risk for transfusion due to symptomatic post-operative anemia. This study aims to investigate whether TA's advantageous effects in the arthroplasty patient population can be extrapolated to the more unstable, heterogeneous hip fracture patient population. If the study is able to show a difference in blood loss and transfusion requirement, the long term implications of this with regards to cost and mortality can be significant.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Control: Saline |
| Interventional | Active comparator | Drug: Tranexamic Acid |
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 Bryn Mawr Hospital with fracture of the femoral neck, intertrochanteric region, or subtrochanteric region of the femur will be considered for the study.
Key exclusion criteria (11 listed)
- age under 18
- allergy to TA
- known current or history of venous thromboembolism (VTE)
- history of known coagulopathy or bleeding disorder
- current subarachnoid hemorrhage
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 |
|---|---|---|
| Control: Saline | Drug | Control |
| Tranexamic Acid | Drug | Interventional |
Primary outcome
calculation of blood loss during the perioperative period
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2-3 days
This study aims to investigate the effect of tranexamic acid (TA) on blood loss and transfusion requirement during the perioperative period in patients who are admitted to the hospital with fracture of the hip and undergo surgical treatment. Both the drop in hemoglobin level from time of surgery (T0 being defined as just prior to surgery, while the patient waits in surgical holding area) over the subsequent several days, as well as post-operative transfusion rate, will be measured. The researchers' hypothesis is that both the hemoglobin drop and the subsequent transfusion requirement in patients who receive TA will be less than those who received saline placebo.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid in people with Hip Fracture, run by Rothman Institute Orthopaedics 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 11 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: status not confirmed, as of the sponsor's last update on 14 Apr 2016. 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. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Morrison, MS, CCRP (267-339-7818, tiffany.morrison@rothmaninstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calculation of blood loss during the perioperative period (time frame: participants will be followed for the duration of hospital stay, an expected average of 2-3 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 14 Apr 2016.