“Randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in patients with hip fracture”.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Asociacion Instituto Biogipuzkoa

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

17 May 2023 → ongoing

Decision date (initial)

2024-11-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519349-31-00

EudraCT number

2020-002144-23

ClinicalTrials.gov

NCT05489185

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Compare the efficacy of treatment with tranexamic acid (TXA) in patients with hip
fracture, both in hospital admission (intravenously) and perioperatively (local and
intravenous), and observe if this translates into a lower rate of blood transfusion.

Secondary objectives 1

1. Evaluate the efficacy of TXA preventive treatment and assess whether this translates into less hidden blood loss during the preoperative period. - Evaluate the efficacy of TXA treatment and assess whether this translates into a decrease in total blood loss. - Evaluate the efficacy of TXA treatment and assess whether it translates into a shorter hospital stay. - Evaluate the presence / absence and difference in the incidence of adverse events

Conditions and MedDRA coding

Hip fracture

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Who is over 65 years of age, of both sexes. - Accept participation in the study (informed consent that will be signed by the patient or family member / legal representative depending on the degree of autonomy of the patient).

Exclusion criteria 1

1. In treatment with another experimental drug (not participating in another clinical trial with an experimental drug). - The refusal of the patient to participate in the study. - Known allergy to TXA. - Patients with a history of seizures. - Patients with severe kidney and liver failure.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - Blood transfusion The first result of this study will be the transfusion rate from patient admission to hospital discharge. Patients will be monitored with serial measurements of hemoglobin and hematocrit levels, as well as vital signs and symptoms to assess the need for transfusion.

Secondary endpoints 18

1. - Hb level: Hb admission, (day 0) Hb day 1, Hb day 2, Hb day 3, Hb preQ, Hb postQ1, Hb postQ2, Hb postQ3
2. - Hto level
3. - Occult blood loss: from fracture to admission, and from admission to surgery
4. - Total loss of blood.
5. . - Adverse events during hospital admission and 3-6-9-12 months postopitalar: DVT, PE, CVA, heart attack, wound infection, urinary infection, respiratory infection, dementia / delirium, wound hematoma-seroma, readmission , reoperation, transfusion reaction, death.
6. . - Charlson comorbidities index.
7. - ASA
8. - Tto. with anticoagulant, antiplatelet medication.
9. - Epidemiological data: age, sex, weight, height.
10. - Time from trauma to hospital admission (in hours).
11. - Previous functionality.
12. - Date of admission.
13. - Date of surgical intervention.
14. - Date of hospital discharge
15. - Hospital stay
16. - Type of fracture.
17. - Type of surgical intervention.
18. - Functionality per year.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Asociacion Instituto Biogipuzkoa

Sponsor organisation

Asociacion Instituto Biogipuzkoa

Address

Pasealeku Doct. Begiristain S/N

City

Donostia

Postcode

20014

Country

Spain

Scientific contact point

Organisation

Asociacion Instituto Biogipuzkoa

Contact name

Biogipuzkoa

Public contact point

Organisation

Asociacion Instituto Biogipuzkoa

Contact name

Biogipuzkoa

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications