Dysplasia, Congenital HipNCT02253810
Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy
A study testing Tranexamic Acid in people with Dysplasia, Congenital Hip, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The goal of this randomized controlled, double-blinded trial is to assess the efficacy of intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Dysplasia, Congenital Hip
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age greater than or equal to 12 years old
- Age less than or equal to 45 years old
- Indicated for elective periacetabular osteotomy
Who cannot join
- Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)
- History of hypersensitivity to tranexamic acid
- History of thromboembolic event (e.g., Pulmonary embolism or Deep vein thrombosis)
- History of subarachnoid hemorrhage
- History or evidence of hepatic dysfunction (aspartate transaminase-alanine transaminase ratio greater than 60) or renal dysfunction (Creatinine greater than 1.5 mg/dL, or glomerular filtration rate less than 30 mL/minute)
- History of seizure
Show all 23Show fewer
- Coronary stents or prior diagnosis of coronary artery disease
- Color blindness
- Leukemia
- Congenital or acquired coagulopathy as evidence by international normalized ratio (INR) greater than 1.4 or partial thromboplastin time (PTT) > 1.4 times normal, or Platelets less than 150,000/mm^3 on preoperative laboratory testing
- Use of hormone replacement therapy or hormonal contraceptive agent within 7 days prior to surgery
- Pregnant
- Breastfeeding
- Donated preoperative autologous blood
- Younger than 12-years-old and older than 45-years-old
- Preoperative hemoglobin less than 10 g/dL
- Concomitant open procedures (e.g., femoral osteotomy or osteochondral allograft)
- Patients with any contraindication to neuraxial anesthesia:
- Patient refusal
- History of lumbar spinal fusion
- Infection at the site of the epidural
- Coagulopathy, as defined above
- Ventriculoperitoneal shunt
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: The Effect of Intravenous Tranexamic Acid on Blood Loss and Transfusion After Periacetabular Osteotomy: a Prospective, Double-blinded, Randomized Controlled Trial
The goal of this randomized controlled, double-blinded trial is to assess the efficacy of intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint. The investigators hypothesize that tranexamic acid will be more effective than placebo (normal saline solution) in reducing blood loss and transfusion after periacetabular osteotomy.
Read the detailed description
Periacetabular osteotomy (PAO) is an elective reorientation surgery for the hip joint, typically for the treatment of hip dysplasia in young, otherwise healthy patients, which requires multiple pelvic osteotomies around the acetabulum. A major source of its perioperative morbidity is blood loss. The principal cause of postoperative blood loss after PAO is surgical trauma, with secondary activation of both the coagulation cascade and local fibrinolysis. In the PAO literature, allogeneic transfusion rates are as high as 58%, and blood loss can range to nearly 4 L. The risk of excessive blood loss and blood transfusion in young, healthy patients after elective surgery is an event that can be reduced with blood conservation protocols, which can include pharmacological agents. Tranexamic acid is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation that interferes with fibrinolysis. Multiple studies and meta-analyses have shown that intravenous administration of the antifibrinolytic agent tranexamic acid reduces postoperative bleeding and the need for transfusion during joint replacement surgery. However, no published data exists to support its use during PAO. We hypothesize that intravenous tranexamic acid will reduce perioperative blood loss and, thus, transfusion requirement in patients undergoing PAO. A total of 80 patients will be enrolled. Patients will be randomized to receive either intravenous tranexamic acid versus placebo (normal saline) during PAO. Calculated total blood loss (primary outcome) will be determined, and intraoperative cell saver utilization (secondary outcome), and (3) postoperative allogeneic blood transfusion (secondary outcome) will be recorded. Patients will be followed for a total of 6 weeks after surgical intervention. If the use of IV tranexamic acid in the PAO patient population significantly reduces total perioperative blood loss, then it would provide an efficacious and inexpensive method for reducing postoperative morbidity after PAO.
- Conditions
- Dysplasia, Congenital Hip
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Dysplasia, Congenital Hip, Osteotomy, Blood Transfusion, Tranexamic Acid
- Medical subject headings
- Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA
Medication administered intra-operatively to promote blood clotting.
PlaceboDrug
Also called Saline
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Experimental | Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively. Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated Total Blood Loss
Calculated total blood loss by patients
Measured: 1day (Hospital Admission)
Secondary outcomes (1)
Number of Patients With Allogenic Blood Transfusion
Total allogenic blood transfusion
Measured: 1day (Hospital Admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dysplasia, Congenital HipStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernest L. Sink, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253810
- Sponsor's protocol ID
- 2014-115
- Status last verified
- Nov 2022
- First submitted
- 29 Sep 2014
- Last updated
- 25 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Tranexamic Acid on Blood Loss and Transfusion After Periacetabular Osteotomy: a Prospective, Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02253810
- Acronym / sponsor ID
- 2014-115
- Conditions
- Dysplasia, Congenital Hip
- Keywords
- Dysplasia, Congenital Hip, Osteotomy, Blood Transfusion, Tranexamic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Posted 25 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled, double-blinded trial is to assess the efficacy of intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint. The investigators hypothesize that tranexamic acid will be more effective than placebo (normal saline solution) in reducing blood loss and transfusion after periacetabular osteotomy.
Detailed description
Periacetabular osteotomy (PAO) is an elective reorientation surgery for the hip joint, typically for the treatment of hip dysplasia in young, otherwise healthy patients, which requires multiple pelvic osteotomies around the acetabulum. A major source of its perioperative morbidity is blood loss. The principal cause of postoperative blood loss after PAO is surgical trauma, with secondary activation of both the coagulation cascade and local fibrinolysis. In the PAO literature, allogeneic transfusion rates are as high as 58%, and blood loss can range to nearly 4 L. The risk of excessive blood loss and blood transfusion in young, healthy patients after elective surgery is an event that can be reduced with blood conservation protocols, which can include pharmacological agents. Tranexamic acid is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation that interferes with fibrinolysis. Multiple studies and meta-analyses have shown that intravenous administration of the antifibrinolytic agent tranexamic acid reduces postoperative bleeding and the need for transfusion during joint replacement surgery. However, no published data exists to support its use during PAO. We hypothesize that intravenous tranexamic acid will reduce perioperative blood loss and, thus, transfusion requirement in patients undergoing PAO. A total of 80 patients will be enrolled. Patients will be randomized to receive either intravenous tranexamic acid versus placebo (normal saline) during PAO. Calculated total blood loss (primary outcome) will be determined, and intraoperative cell saver utilization (secondary outcome), and (3) postoperative allogeneic blood transfusion (secondary outcome) will be recorded. Patients will be followed for a total of 6 weeks after surgical intervention. If the use of IV tranexamic acid in the PAO patient population significantly reduces total perioperative blood loss, then it would provide an efficacious and inexpensive method for reducing postoperative morbidity after PAO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Experimental | Drug: Tranexamic AcidPatients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively. |
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 12 years old
- Age less than or equal to 45 years old
- Indicated for elective periacetabular osteotomy
Key exclusion criteria (23 listed)
- Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)
- History of hypersensitivity to tranexamic acid
- History of thromboembolic event (e.g., Pulmonary embolism or Deep vein thrombosis)
- History of subarachnoid hemorrhage
- History or evidence of hepatic dysfunction (aspartate transaminase-alanine transaminase ratio greater than 60) or renal dysfunction (Creatinine greater than 1.5 mg/dL, or glomerular filtration rate less than 30 mL/minute)
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: TXAMedication administered intra-operatively to promote blood clotting. | Drug | Tranexamic Acid |
| PlaceboAlso: SalineSaline solution | Drug | Placebo |
Primary outcome
Calculated Total Blood Loss
Time frame: 1day (Hospital Admission)
Calculated total blood loss by patients
1 secondary outcome
Number of Patients With Allogenic Blood Transfusion
Time frame: 1day (Hospital Admission)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ernest L. Sink, MD principal investigator
Hospital for Special Surgery, New York
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 Dysplasia, Congenital Hip, run by Hospital for Special Surgery, New York 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 23 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 25 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Calculated Total Blood Loss (time frame: 1day (Hospital Admission)). 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 25 Nov 2022.