Clinical trial • Phase IV • Musculoskeletal

Tranexamic acid for Hip osteoarthritis | Osteoarthritis

Phase IV trial of Tranexamic acid for Hip osteoarthritis | Osteoarthritis.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Hip osteoarthritis | Osteoarthritis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-10-2024
First CTIS Authorization Date
15-11-2024

Trial design

Randomised, iv txa at the start of surgery + injection of equal volume of nacl (placebo) into the joint at end of surgery-controlled Phase IV trial across 1 site in Denmark.

Randomised
Yes
Comparator
IV TXA at the start of surgery + injection of equal volume of NaCl (placebo) into the joint at end of surgery
Target Sample Size
100
Trial Duration For Participant
90

Eligibility

Recruits 100 No vulnerable population selected. Participants must be able to give consent: "Able to give ones consent either verbally or written." Exclusion includes inability to speak and understand Danish, and minimum age requirement (≥ 18 years). No special assent procedures or paediatric consent described..

Pregnancy Exclusion
- Females: menstruation within the last 12 months
Vulnerable Population
No vulnerable population selected. Participants must be able to give consent: "Able to give ones consent either verbally or written." Exclusion includes inability to speak and understand Danish, and minimum age requirement (≥ 18 years). No special assent procedures or paediatric consent described.

Inclusion criteria

  • {"criterion_text":"- ≥ 18 years\n- Undergoing surgery for unilateral total hip arthroplasty\n- Able to give ones consent either verbally or written."}

Exclusion criteria

  • {"criterion_text":"- - Operation performed in general anaesthesia\n- - Patients who are not able to speak and understand Danish\n- - Patients who refuse to receive blood products\n- - Present acute thromboembolic event (DVT, AMI, cerebral infarction, pulmonary embolism)\n- - Disseminated intravascular coagulation (DIC) or active thromboembolic disease\n- - Active cancer disease\n- - Had one of the following type of trauma or surgeries in the affected hip: Hip fractures, periacetabulær osteotomy, femurosteotomy, trochanterostetomi.\n- - Rheumatic arthritis.\n- - Allergi to TXA\n- - In treatment with the following anticoagulatia: ADP receptorinhibitors, vitamin-K antagonist(within 5-7 days before the operation). Factor Xa inhibitors, thrombine-inhibitors\n- - Use of oral anticonceptiva\n- - Known with thrombophilia\n- - Reduced kidney function (GFR <45 ml/hour)\n- - Participated in a clinical trial within the last 30 days\n- - Alcoholism and morphinism\n- - Females: menstruation within the last 12 months"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Total blood loss 24 hours after the operation","definition_or_measurement_approach":"Primary endpoint is total blood loss 24 hours after surgery."}

Secondary endpoints

  • {"endpoint_text":"- Total blood loss on the morning af the 2nd postoperative day.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Secondary endpoints is total bleeding 2 days after surgery, likewise the amount of blood transfusion and the thromboembolic events within the first 90 days of surgery.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
100
Recruitment Window Months
72
Consent Approach
Participants must be able to give consent either verbally or written ("Able to give ones consent either verbally or written."). A subject information and informed consent form document is present. Exclusion includes inability to speak and understand Danish, indicating consent process is expected in Danish. No separate assent or age-specific consent procedures described.

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Denmark

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
15-11-2024
Processing Time Days
4
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Hvidovre Hospital
Department Name
Orthopeadic Surgery
Principal Investigator Name
Christian Nielsen
Principal Investigator Email
christian.skovgaard.nielsen@regionh.dk
Contact Person Name
Christian Nielsen
Number Of Participants
100

Sponsor

Primary sponsor

Full Name
Region Hovedstaden
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP unit at University of Copenhagen","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
Tranexamic Acid 100 mg/ml Solution for Injection
Active Substance
Tranexamic acid
Modality
Small molecule
Routes Of Administration
INTRA-ARTICULAR INJECTION
Route
Intra-articular injection
Authorisation Status
Marketing authorisation (PL 11311/0613)
Maximum Dose
3 g per day; 5 g total
Combination Treatment
Yes

Related trials

Other published trials that may interest you.