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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Haseki TRH

    Istanbul, Sultangazi, 34000

Other trials in Turkey (Türkiye)

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.

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.

Study groups in NCT05359172
Study groupRoleWhat they receive
Tranexamic acidThey will receive preoperative intravenous tranexamic acid infusions.
Receives: Drug: Tranexamic acid
ControlsThey will not receive intravenous tranexamic acid infusions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total blood loss

    Estimated total blood loss (L) =Blood volume × (Hctpreop -Hctpostop) /[(Hctpreop +Hctpostop)/2]

    Measured: 2 days

Secondary outcomes (1)
  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.

  1. First posted3 May 2022
  2. Study start1 Apr 2021
  3. Primary completion9 Jul 2022
  4. Study completion10 Jul 2022

Resources

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)
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 26978136
  • Tengberg 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

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.

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