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Fracture of FemurPhase 4NCT04290884

Tranexamic Acid in Chinese Elderly Patients With Intertrochanteric Fracture RCT

A Phase 4 study testing Tranexamic Acid in people with Fracture of Femur, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hip fracture posed a major challenge to the health care system, with the one-year mortality of hip fracture reported as being approximately 20%. Perioperative haemoglobin level was associated with functional level of the patient and even mortality. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Fracture of Femur
What is being tested?
Tranexamic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteHong Kong
Study dates
23 May 2018to May 2020
Phase
Phase 4
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults over the age of 60
  • Acute isolated intertrochanteric fracture and sub trochanteric fracture treated with short proximal femoral nailing

Who cannot join

  • Use of any anticoagulant at the time of admission
  • Documented allergy to tranexamic acid
  • History of pulmonary embolism or deep vein thrombosis
  • Hepatic failure
  • Severe renal insufficiency
  • Active coronary artery disease in the past 12 months
Show all 13Show fewer
  • History of cerebrovascular accident in the past 12 months
  • Presence of a drug-eluting stent
  • Active oncological diseases
  • Coagulopathy (international normalised ratio (INR)>1.4)
  • Pathological fractures
  • Periprosthetic fractures
  • Operation >2 days from admission

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: The Use of Tranexamic Acid in Chinese Elderly Patients Undergoing Femoral Nailing for Intertrochanteric Fracture: A Randomized Controlled Trial

Hip fracture posed a major challenge to the health care system, with the one-year mortality of hip fracture reported as being approximately 20%. Perioperative haemoglobin level was associated with functional level of the patient and even mortality.

Different methods for administration of tranexamic acid had been described. It was well established that systemic administration of tranexamic acid could reduce perioperative blood loss and transfusion rate. Topical administration had been shown to decrease blood loss and transfusion rate.

The objective of our study is to investigate the hypothesis that tranexamic acid will reduce blood loss and transfusion rate in elderly patients undergoing hip fracture surgery.

Read the detailed description

The incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years as the world population ages. Hip fracture in elderly patients are associated with significant morbidity and mortality. One of the significant morbidity is blood loss, which has been reported as high as 1500ml. Blood loss may lead subsequent blood transfusion. The rate of blood transfusion has been reported between 20 to 60%. Blood loss and subsequent blood transfusion could lengthen the overall hospital length of stay and delay the rehabilitation.

Tranexamic acid, one of antifibrinolytic agents, is a synthetic derivative of the amino acid lysine and acts as a competitive inhibitor in the activation of plasminogen to plasmin, therefore preventing the degradation of fibrin. Shakur et al. reported that the use could reduce mortality in trauma patients. Tranexamic acid has been widely used in elective orthopaedic surgery such as total joint replacement and spine surgery. Several authors reported that tranexamic acid could decreases the blood loss, transfusion rate and cost.

Being tested
Tranexamic Acid
Keywords
elderly, intertrochanteric fracture
Medical subject headings
Femoral Fractures, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Also called Transamin

    The recruited patients will be randomly assigned to two groups, 50% chance to the experimental group (use of tranexamic acid) and 50% chance to the control group (use of normal saline). After the reduction of the intertrochanteric fracture, 10ml of tranexamic acid is injected under the deep fascia around the fracture area before inserting a drain. As for the control group, 10ml of normal saline is injected instead. Blood will be taken on the third day post operation, and the patient will be seen at 6 weeks, and 3 months.

Study groups in NCT04290884
Study groupRoleWhat they receive
Local administration of tranexamic acidExperimental1. All patients hip fracture will be treated according to the hospital standard procedure 2. Check complete blood count on admission and Day 3 post-operation. 3. 10ml tranexamic acid injected under the deep fascia around the fracture site under x-ray control 4. Sealed envelope system: Operation room nurse will open a sealed envelope for treatment allocation. The medications are prepared by the nurse according to the instruction inside the envelop. 5. Transfusion when clinically indicated or Hb < 8g/dL 6. Blood Loss calculation (formula of Nadler, Hidalgo and Bloch) 7. Blood taken at Day 3 post-operation will be used for measure of postoperative haematocrit. By this time postoperatively fluid shift has settled and the patient is haemodynamically stable. 8. After discharge, patients will be seen in 6 weeks and 3 months
Receives: Drug: Tranexamic Acid
Control groupNo intervention1. All patients hip fracture will be treated according to the hospital standard procedure 2. Check complete blood count on admission and Day 3 post-operation. 3. 10ml normal saline injected under the deep fascia around the fracture site under x-ray control 4. Sealed envelope system: Operation room nurse will open a sealed envelope for treatment allocation. The medications are prepared by the nurse according to the instruction inside the envelop. 5. Transfusion when clinically indicated or Hb < 8g/dL 6. Blood Loss calculation (formula of Nadler, Hidalgo and Bloch) 7. Blood taken at Day 3 post-operation will be used for measure of postoperative haematocrit. By this time postoperatively fluid shift has settled and the patient is haemodynamically stable. 8. After discharge, patients will be seen in 6 weeks and 3 months

What is being measured

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

  1. Transfusion rate

    The total blood transfusion post operation

    Measured: Day 3 post operation

  2. Blood loss

    Blood loss calculation according to formula of Nadler, Hidalgo and Bloch

    Measured: Day 3 post operation

Secondary outcomes (2)

  1. 3 months mortality rate

    mortality rate of the patient within post operation 3 months

    Measured: from post operation to 3 months

  2. Complications

    Complications related to thrombotic events

    Measured: from post operation to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start23 May 2018
  3. Primary completion14 Feb 2020
  4. Study completionMay 2020 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290884
Sponsor's protocol ID
UW 18-038
Status last verified
Mar 2020
First submitted
27 Feb 2020
Last updated
19 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Schneider EL, Guralnik JM. The aging of America. Impact on health care costs. JAMA. 1990 May 2;263(17):2335-40.

    PubMed 2109105

  • Bhaskar D, Parker MJ. Haematological indices as surrogate markers of factors affecting mortality after hip fracture. Injury. 2011 Feb;42(2):178-82. doi: 10.1016/j.injury.2010.07.501.

    PubMed 20850741

  • Foss NB, Kristensen MT, Kehlet H. Anaemia impedes functional mobility after hip fracture surgery. Age Ageing. 2008 Mar;37(2):173-8. doi: 10.1093/ageing/afm161.

    PubMed 18349013

  • Lawrence VA, Silverstein JH, Cornell JE, Pederson T, Noveck H, Carson JL. Higher Hb level is associated with better early functional recovery after hip fracture repair. Transfusion. 2003 Dec;43(12):1717-22. doi: 10.1046/j.0041-1132.2003.00581.x.

    PubMed 14641869

  • Zhang P, He J, Fang Y, Chen P, Liang Y, Wang J. Efficacy and safety of intravenous tranexamic acid administration in patients undergoing hip fracture surgery for hemostasis: A meta-analysis. Medicine (Baltimore). 2017 May;96(21):e6940. doi: 10.1097/MD.0000000000006940.

    PubMed 28538384

  • 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?

A Phase 4 study testing Tranexamic Acid in people with Fracture of Femur, run by The University of Hong Kong at 1 site in Hong Kong.

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 13 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 19 Mar 2020. 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 Hong Kong. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

Transfusion rate (time frame: Day 3 post operation). The study lists 2 primary outcomes in all. 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 NCT04290884, which also lists 7 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 19 Mar 2020.

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