Hip FracturesNCT05359172
The Effect of Tranexamic Acid in Total Blood Loss During Proximal Femoral Nailing
An observational study of Hip Fractures and Intertrochanteric Fractures, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Blood loss is an important issue following intertrochanteric femoral fracture and may lead to requiring blood transfusions and transfusion complications. Tranexamic acid is a commonly used drug to decrease blood loss and the number of transfusions. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Intertrochanteric Fractures, Blood Loss
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 10 Jul 2022
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients who have intertrochanteric femoral fracture and will be treated using closed reduction and proximal femoral nailing
Who may be able to join
- Patients aged ≥ 65 years with intertrochanteric fracture
- Treated with closed reduction and proximal femoral nailing
- Injury time ≤ 8 h.
Who cannot join
- Having undergone previous surgery on the same hip,
- Fracture requiring open reduction,
- Having any contraindications for the use of tranexamic acid
- Patients with recent or ongoing thromboembolic events
- Patients who were recently taking or who were taking anticoagulation therapy and platelet aggregation inhibitors;
- Patients with disseminated intravascular coagulation or patients had hepatic or renal diseases with impairment of coagulation function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Tranexamic Acid Significantly Reduce Total Blood Loss During Proximal Femoral Nailing for the Intertrochanteric Femoral Fracture in the Elderly?
Blood loss is an important issue following intertrochanteric femoral fracture and may lead to requiring blood transfusions and transfusion complications. Tranexamic acid is a commonly used drug to decrease blood loss and the number of transfusions. The aim of our study is to determine the effectiveness of tranexamic acid use to reduce total blood loss during proximal femoral nailing for the intertrochanteric femoral fracture in the elderly.
Patients aged >65 years and diagnosed with intertrochanteric fracture will be included in the study. The patients will be numbered according to the admission to the hospital and randomly divided into two groups. First group will receive tranexamic acid infusion and second group will not receive tranexamic acid infusion. Total blood loss will be calculated using Nadler formula. The primary outcome of the study is total blood loss. The secondary outcomes are a number of transfusions, and surgical blood loss during the operative procedure.
Read the detailed description
Introduction Intertrochanteric femur fractures may cause an average of 800-1500 cc of bleeding. Hip fractures, which reduce the intravascular volume so much, can cause serious metabolic problems in the elderly patient population. There may also be some blood loss during the operation, and these blood losses can cause decreased mobility, overload of the cardiovascular system, deterioration of tissue oxygenation, increased mortality and morbidity. In addition, it may require blood transfusion and cause possible tranfusion complications.
The aim of our study is to determine the effectiveness of tranexamic acid use to reduce total blood loss during proximal femoral nailing for the intertrochanteric femoral fracture in the elderly.
Material and method Patients diagnosed with intertrochanteric fractures admitted to the emergency department between April 1, 2020 and April 30, 2022 were eligible for this study. Inclusion criteria were (1) Patients aged ≥ 65 years with intertrochanteric fracture (2) treated with closed reduction and proximal femoral nailing (3) injury time ≤ 8 h. Exclusion criteria were having undergone previous surgery on the same hip, fracture requiring open reduction, having any contraindications for the use of tranexamic acid (allergy, previous thromboembolic event, creatinine clearance <30 ml/min, postmenopausal hormonal therapy), patients with recent or ongoing thromboembolic events (deep venous thrombosis, pulmonary embolism, arterial thrombosis, or cerebral thrombosis stroke); patients who were recently taking or who were taking anticoagulation therapy including vitamin K-antagonists, direct thrombin inhibitors, direct factor X-a inhibitors, and platelet aggregation inhibitors; patients with disseminated intravascular coagulation or patients had hepatic or renal diseases with impairment of coagulation function.
When patients apply to our hospital, they will be numbered according to the order of application. It will then be randomized using the www.randomizer.org website. In Group 1, 15 mg/kg tranexamic acid will be administered before the incision, after anesthesia in the form of iv infusion in 100 cc saline. In Group 2, only 100 SF will be applied. During surgery, crystalloid fluids will be administered at a dose of 1.5 ml/kg.h. In case of blood loss; Intravascular volume will be maintained with 3:1 ratio of crystalloid solutions. A change in basal heart rate and blood pressure of more than 20% is considered to be related to hypovolemia and will be replaced with a 10ml/kg bolus of crystalloid solution. Perop blood transfusion will be administered in case of Hb<8 g/dl or suspected myocardial ischemia or hemorrhagic shock. In case of Hb<8 g/dl or Hb<10g/dl and symptoms of hypovolemia (dizziness, orthostatic hypotension, tachycardia), blood transfusion indication will be accepted in the postoperative period.
Electrocautery and aspirator will be routinely used during the surgical procedure in all patients. Preoperative DVT prophylaxis will be applied to the patients and antiembolic stockings will be worn. After the operation of the patient, the total amount of perop bleeding will be determined by removing the irrigation fluids from the total amount of liquid in the aspiration material and the blood on gauzes used in the operation will be added. If there is a drain in the postoperative period, the drainage volume will be added. Nadler's formulae for blood volüme, visible and hidden blood loss were applied after surgery.
Women blood volume(L) =Height(m)3 × 0.356 +Weight(kg)× 0.033 + 0.183
Men blood volume(L) =Height(m)3 × 0.356 +Weight(kg)× 0.032+0.604
Estimated total blood loss (L) =Blood volume × (Hctpreop -Hctpostop) /[(Hctpreop +Hctpostop)/2]
Visible blood loss= (Intraoperative blood loss + Postoperative blood loss)× [Hctpreop +Hctpostop]/2
Hidden blood loss = Estimated total blood loss-Visible blood loss + Transfusion blood
Preop hematocrit(hct) was defined as the hct in the morning of the day of surgery. Postop hct was defined as postoperative 2nd-day hct.
The primary outcome of the study was total blood loss. The secondary outcomes were a number of transfusions, and surgical blood loss during the operative procedure.
The 51 patients in each group and total of 102 patients were needed to provide the study with a power of at least 80% at a two-sided type I error of 5% with an effect size 0.5.
Patients will be followed up on any additional transfusion requirements and treatment needs by performing daily hemograms and laboratory follow-ups for the first three postoperative days. Patients were also evaluated in the first 3 months for any complications.
- Conditions
- Hip Fractures, Intertrochanteric Fractures, Blood Loss
- Being tested
- Tranexamic acid
- Medical subject headings
- Hip Fractures, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
preoperative intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | They will receive preoperative intravenous tranexamic acid infusions. Receives: Drug: Tranexamic acid | |
| Controls | They will not receive intravenous tranexamic acid infusions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss
Estimated total blood loss (L) =Blood volume × (Hctpreop -Hctpostop) /[(Hctpreop +Hctpostop)/2]
Measured: 2 days
Secondary outcomes (1)
number of transfusions
requiring number of blood transfusion
Measured: postroperative first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Apr 2021
- Primary completion9 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359172
- Sponsor's protocol ID
- HAS2022-21
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drakos A, Raoulis V, Karatzios K, Doxariotis N, Kontogeorgakos V, Malizos K, Varitimidis SE. Efficacy of Local Administration of Tranexamic Acid for Blood Salvage in Patients Undergoing Intertrochanteric Fracture Surgery. J Orthop Trauma. 2016 Aug;30(8):409-14. doi: 10.1097/BOT.0000000000000577.
PubMed 26978136Tengberg PT, Foss NB, Palm H, Kallemose T, Troelsen A. Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip: results of a randomised controlled trial. Bone Joint J. 2016 Jun;98-B(6):747-53. doi: 10.1302/0301-620X.98B6.36645.
PubMed 27235515
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Tranexamic Acid Significantly Reduce Total Blood Loss During Proximal Femoral Nailing for the Intertrochanteric Femoral Fracture in the Elderly?
- ClinicalTrials.gov ID
- NCT05359172
- Acronym / sponsor ID
- HAS2022-21
- Conditions
- Hip Fractures, Intertrochanteric Fractures, Blood Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 3 May 2022 (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.
Blood loss is an important issue following intertrochanteric femoral fracture and may lead to requiring blood transfusions and transfusion complications. Tranexamic acid is a commonly used drug to decrease blood loss and the number of transfusions. The aim of our study is to determine the effectiveness of tranexamic acid use to reduce total blood loss during proximal femoral nailing for the intertrochanteric femoral fracture in the elderly.
Patients aged >65 years and diagnosed with intertrochanteric fracture will be included in the study. The patients will be numbered according to the admission to the hospital and randomly divided into two groups. First group will receive tranexamic acid infusion and second group will not receive tranexamic acid infusion. Total blood loss will be calculated using Nadler formula. The primary outcome of the study is total blood loss. The secondary outcomes are a number of transfusions, and surgical blood loss during the operative procedure.
Detailed description
Introduction Intertrochanteric femur fractures may cause an average of 800-1500 cc of bleeding. Hip fractures, which reduce the intravascular volume so much, can cause serious metabolic problems in the elderly patient population. There may also be some blood loss during the operation, and these blood losses can cause decreased mobility, overload of the cardiovascular system, deterioration of tissue oxygenation, increased mortality and morbidity. In addition, it may require blood transfusion and cause possible tranfusion complications.
The aim of our study is to determine the effectiveness of tranexamic acid use to reduce total blood loss during proximal femoral nailing for the intertrochanteric femoral fracture in the elderly.
Material and method Patients diagnosed with intertrochanteric fractures admitted to the emergency department between April 1, 2020 and April 30, 2022 were eligible for this study. Inclusion criteria were (1) Patients aged ≥ 65 years with intertrochanteric fracture (2) treated with closed reduction and proximal femoral nailing (3) injury time ≤ 8 h. Exclusion criteria were having undergone previous surgery on the same hip, fracture requiring open reduction, having any contraindications for the use of tranexamic acid (allergy, previous thromboembolic event, creatinine clearance <30 ml/min, postmenopausal hormonal therapy), patients with recent or ongoing thromboembolic events (deep venous thrombosis, pulmonary embolism, arterial thrombosis, or cerebral thrombosis stroke); patients who were recently taking or who were taking anticoagulation therapy including vitamin K-antagonists, direct thrombin inhibitors, direct factor X-a inhibitors, and platelet aggregation inhibitors; patients with disseminated intravascular coagulation or patients had hepatic or renal diseases with impairment of coagulation function.
When patients apply to our hospital, they will be numbered according to the order of application. It will then be randomized using the www.randomizer.org website. In Group 1, 15 mg/kg tranexamic acid will be administered before the incision, after anesthesia in the form of iv infusion in 100 cc saline. In Group 2, only 100 SF will be applied. During surgery, crystalloid fluids will be administered at a dose of 1.5 ml/kg.h. In case of blood loss; Intravascular volume will be maintained with 3:1 ratio of crystalloid solutions. A change in basal heart rate and blood pressure of more than 20% is considered to be related to hypovolemia and will be replaced with a 10ml/kg bolus of crystalloid solution. Perop blood transfusion will be administered in case of Hb<8 g/dl or suspected myocardial ischemia or hemorrhagic shock. In case of Hb<8 g/dl or Hb<10g/dl and symptoms of hypovolemia (dizziness, orthostatic hypotension, tachycardia), blood transfusion indication will be accepted in the postoperative period.
Electrocautery and aspirator will be routinely used during the surgical procedure in all patients. Preoperative DVT prophylaxis will be applied to the patients and antiembolic stockings will be worn. After the operation of the patient, the total amount of perop bleeding will be determined by removing the irrigation fluids from the total amount of liquid in the aspiration material and the blood on gauzes used in the operation will be added. If there is a drain in the postoperative period, the drainage volume will be added. Nadler's formulae for blood volüme, visible and hidden blood loss were applied after surgery.
Women blood volume(L) =Height(m)3 × 0.356 +Weight(kg)× 0.033 + 0.183
Men blood volume(L) =Height(m)3 × 0.356 +Weight(kg)× 0.032+0.604
Estimated total blood loss (L) =Blood volume × (Hctpreop -Hctpostop) /[(Hctpreop +Hctpostop)/2]
Visible blood loss= (Intraoperative blood loss + Postoperative blood loss)× [Hctpreop +Hctpostop]/2
Hidden blood loss = Estimated total blood loss-Visible blood loss + Transfusion blood
Preop hematocrit(hct) was defined as the hct in the morning of the day of surgery. Postop hct was defined as postoperative 2nd-day hct.
The primary outcome of the study was total blood loss. The secondary outcomes were a number of transfusions, and surgical blood loss during the operative procedure.
The 51 patients in each group and total of 102 patients were needed to provide the study with a power of at least 80% at a two-sided type I error of 5% with an effect size 0.5.
Patients will be followed up on any additional transfusion requirements and treatment needs by performing daily hemograms and laboratory follow-ups for the first three postoperative days. Patients were also evaluated in the first 3 months for any complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | – | Drug: Tranexamic acidThey will receive preoperative intravenous tranexamic acid infusions. |
| Controls | – | –They will not receive intravenous tranexamic acid infusions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients who have intertrochanteric femoral fracture and will be treated using closed reduction and proximal femoral nailing
Key inclusion criteria (3 listed)
- Patients aged ≥ 65 years with intertrochanteric fracture
- Treated with closed reduction and proximal femoral nailing
- Injury time ≤ 8 h.
Key exclusion criteria (6 listed)
- Having undergone previous surgery on the same hip,
- Fracture requiring open reduction,
- Having any contraindications for the use of tranexamic acid
- Patients with recent or ongoing thromboembolic events
- Patients who were recently taking or who were taking anticoagulation therapy and platelet aggregation inhibitors;
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 acidpreoperative intravenous infusion | Drug | Tranexamic acid |
Primary outcome
Total blood loss
Time frame: 2 days
Estimated total blood loss (L) =Blood volume × (Hctpreop -Hctpostop) /[(Hctpreop +Hctpostop)/2]
1 secondary outcome
number of transfusions
Time frame: postroperative first month
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 10 Oct 2022.
- Background: PubMed 26978136Drakos A, Raoulis V, Karatzios K, Doxariotis N, Kontogeorgakos V, Malizos K, Varitimidis SE. Efficacy of Local Administration of Tranexamic Acid for Blood Salvage in Patients Undergoing Intertrochanteric Fracture Surgery. J Orthop Trauma. 2016 Aug;30(8):409-14. doi: 10.1097/BOT.0000000000000577.
- Background: PubMed 27235515Tengberg PT, Foss NB, Palm H, Kallemose T, Troelsen A. Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip: results of a randomised controlled trial. Bone Joint J. 2016 Jun;98-B(6):747-53. doi: 10.1302/0301-620X.98B6.36645.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Intertrochanteric Fractures, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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 10 Oct 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 Turkey (Türkiye). 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.
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?
Total blood loss (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05359172, which also lists 2 linked publications.
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 10 Oct 2022.