Back to resultsClinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Hip Fracture Patients.
Primary Purpose
Hip Fractures
Status
Not yet recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Tranexamic acid
Physiologic saline
Sponsored by
About this trial
This is an interventional prevention trial for Hip Fractures focused on measuring Hip Fracture, Blood loss, tranexamic acid
Eligibility Criteria
Inclusion Criteria:
- Patients over 65 years of age, of both sexes, who are going to be operated on for a hip fracture
- Accept participation in the study (informed consent that will be signed by the patient or family member/legal representative depending on the patient's degree of autonomy).
Exclusion Criteria:
- Under treatment with another experimental drug (who is not participating in another clinical trial with an experimental drug).
- The refusal of the patient or their relatives/legal representative to participate in the study.
- Known allergy to TXA.
- Patients with a history of seizures.
- Patients with severe renal and hepatic insufficiency.
- Patients with hypersensitivity to any of the excipients indicated in the tranexamic acid data sheet, acute arterial or venous thrombosis.
- Patients with active concomitant bleeding of renal origin.
Sites / Locations
- Asociación Instituto Biodonostia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Active Comparator
Experimental
Arm Label
Extracapsular fracture with intravenous contraindication (control).
Extracapsular fracture with intravenous contraindication (experimental).
Extracapsular fracture without intravenous contraindication (control).
Extracapsular fracture without intravenous contraindication (experimental).
Intracapsular fracture with intravenous contraindication (control).
Intracapsular fracture with intravenous contraindication (experimental).
Intracapsular fracture without intravenous contraindication (control).
Intracapsular fracture without intravenous contraindication (experimental).
Arm Description
Physiological saline
Amchafibrin
Physiological saline
Amchafibrin
Physiological saline
Amchafibrin
Physiological saline
Amchafibrin
Outcomes
Primary Outcome Measures
Blood transfusion
Transfusion rate from patient admission to hospital discharge.
Secondary Outcome Measures
Total blood loss
Adverse events
Days at hospital
Full Information
NCT ID
NCT05489185
First Posted
August 1, 2022
Last Updated
May 16, 2023
Sponsor
Asociacion Instituto Biodonostia
1. Study Identification
Unique Protocol Identification Number
NCT05489185
Brief Title
Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Hip Fracture Patients.
Official Title
"Randomized, Double-blind Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Patients With Hip Fracture"
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asociacion Instituto Biodonostia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality.
Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis.
It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.
Detailed Description
Prevention and treatment of bleeding due to general or local fibrinolysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip Fracture, Blood loss, tranexamic acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
644 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extracapsular fracture with intravenous contraindication (control).
Arm Type
Placebo Comparator
Arm Description
Physiological saline
Arm Title
Extracapsular fracture with intravenous contraindication (experimental).
Arm Type
Experimental
Arm Description
Amchafibrin
Arm Title
Extracapsular fracture without intravenous contraindication (control).
Arm Type
Placebo Comparator
Arm Description
Physiological saline
Arm Title
Extracapsular fracture without intravenous contraindication (experimental).
Arm Type
Experimental
Arm Description
Amchafibrin
Arm Title
Intracapsular fracture with intravenous contraindication (control).
Arm Type
Placebo Comparator
Arm Description
Physiological saline
Arm Title
Intracapsular fracture with intravenous contraindication (experimental).
Arm Type
Experimental
Arm Description
Amchafibrin
Arm Title
Intracapsular fracture without intravenous contraindication (control).
Arm Type
Active Comparator
Arm Description
Physiological saline
Arm Title
Intracapsular fracture without intravenous contraindication (experimental).
Arm Type
Experimental
Arm Description
Amchafibrin
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Intravenous or topical administration
Intervention Type
Other
Intervention Name(s)
Physiologic saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Blood transfusion
Description
Transfusion rate from patient admission to hospital discharge.
Time Frame
From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Secondary Outcome Measure Information:
Title
Total blood loss
Time Frame
From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Title
Adverse events
Time Frame
3,6,9 and 12 months
Title
Days at hospital
Time Frame
From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over or equal to 65 years of age, of both sexes, who are going to be operated on for a hip fracture
Accept participation in the study (informed consent that will be signed by the patient or family member/legal representative depending on the patient's degree of autonomy).
Exclusion Criteria:
Under treatment with another experimental drug (who is not participating in another clinical trial with an experimental drug).
The refusal of the patient or their relatives/legal representative to participate in the study.
Known allergy to TXA ( Hipersensivity to TXA o to any of the excipients).
Patients with a history of seizures.
Patients with severe renal and hepatic insufficiency.
Patients with venous thrombosis.
Patients with active concomitant bleeding of renal origin.
Facility Information:
Facility Name
Asociación Instituto Biodonostia
City
San Sebastián
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Hip Fracture Patients.
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