Acute Blood Loss AnemiaPhase 1NCT01683955
Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty
A Phase 1 study testing Tranexamic acid in people with Acute Blood Loss Anemia and Osteoarthritis, Hip, run by Henry Ford Health System at 2 sites in United States.
Trial summary
This study aims to assess postoperative blood loss and transfusion rates in total hip replacement after one-time administration of topical tranexamic acid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Blood Loss Anemia, Osteoarthritis, Hip
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2013to 3 Nov 2013
- Phase
- Phase 1
- 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
- All adult patients over age eighteen
- Primary unilateral total hip arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)
Who cannot join
- patient history of venous thromboembolic disease or coagulopathy
- use of anticoagulant medications within 7 days of surgery
- history of arterial embolic disease
- history of Class III or IV heart failure
- renal failure
- intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford Hospital
Detroit, Michigan, 48067
HFH Main campus
Detroit, Michigan, 48202
About this study
This study aims to assess postoperative blood loss and transfusion rates in total hip replacement after one-time administration of topical tranexamic acid.
Read the detailed description
Autologous (donor) blood transfusion is an expensive and common occurrence after total hip replacement. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total hip replacements, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total hip arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.
- Conditions
- Acute Blood Loss Anemia, Osteoarthritis, Hip
- Being tested
- Tranexamic acid, Placebo
- Keywords
- Tranexamic Acid, Blood transfusion, Total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called cyclokapron
Topical tranexamic acid (2g/100mL 0.9% saline)
PlaceboDrug
100mL 0.9% sterile saline
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Topical tranexamic acid (2g/100mL) applied during unilateral total hip arthroplasty. Receives: Drug: Tranexamic acid |
| Placebo | Placebo comparator | 100mL 0.9% sterile saline, applied topically Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative blood loss
Preoperative and lowest postoperative hemoglobin
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (1)
postoperative transfusion rate
number of units transfused postoperatively
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study start1 Jan 2013
- Primary completion3 Nov 2013
- Study completion3 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Blood Loss AnemiaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Laker, M.D., Principal investigator, Henry Ford Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683955
- Sponsor's protocol ID
- TEAHIPS
- Status last verified
- Mar 2023
- First submitted
- 8 Sep 2012
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01683955
- Acronym / sponsor ID
- TEAHIPS
- Conditions
- Acute Blood Loss Anemia, Osteoarthritis, Hip
- Keywords
- Tranexamic Acid, Blood transfusion, Total hip arthroplasty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 3 Nov 2013 (actual)
- Study completion
- 3 Nov 2013 (actual)
- First posted
- 12 Sep 2012 (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.
This study aims to assess postoperative blood loss and transfusion rates in total hip replacement after one-time administration of topical tranexamic acid.
Detailed description
Autologous (donor) blood transfusion is an expensive and common occurrence after total hip replacement. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total hip replacements, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total hip arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.
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 | Experimental | Drug: Tranexamic acidTopical tranexamic acid (2g/100mL) applied during unilateral total hip arthroplasty. |
| Placebo | Placebo comparator | Drug: Placebo100mL 0.9% sterile saline, applied topically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients over age eighteen
- Primary unilateral total hip arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)
Key exclusion criteria (6 listed)
- patient history of venous thromboembolic disease or coagulopathy
- use of anticoagulant medications within 7 days of surgery
- history of arterial embolic disease
- history of Class III or IV heart failure
- renal failure
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: cyclokapronTopical tranexamic acid (2g/100mL 0.9% saline) | Drug | Tranexamic Acid |
| Placebo100mL 0.9% sterile saline | Drug | Placebo |
Primary outcome
postoperative blood loss
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Preoperative and lowest postoperative hemoglobin
1 secondary outcome
postoperative transfusion rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
Related trials for Acute Blood Loss Anemia
Active, not recruiting
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Acute Leukemia, Acute Myeloid Leukemia (AML)
RecruitingObservational study
National Longitudinal Cohort of Hematological Diseases
Multiple Myeloma, Acute Myeloid Leukemia
RecruitingObservational study
The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma
Trauma Injury, Trauma
RecruitingObservational study
High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT)
Hematopoietic Stem Cell Transplantation (HSCT), Acute Myeloid Leukemia (AML)
RecruitingPhase 4
Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
Acute Blood Loss Anemia, Fracture
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.
Michael Laker, M.D. principal investigator
Henry Ford Health Systems
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tranexamic acid in people with Acute Blood Loss Anemia and Osteoarthritis, Hip, run by Henry Ford Health System at 2 sites 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative blood loss (time frame: participants will be followed for the duration of hospital stay, an expected average of 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 3 Apr 2023.