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Does Tranexamic acid, a medicine used in treating and preventing bleeding problems, reduce the blood loos when it is injected directly into the hip joint after insertion of a total hip prosthesis
EU CTIS ID: 2024-517398-26-01
What this study is testing
In this RCT-study we investigate the potential additive effect of intraarticular injected Tranexamic Acid (TXA) for the total blood loss in unilateralt total hip arthroplasty in addition to conventional treatment with IV TXA. The intervention group will be given IV TXA at the start of surgery + injection of TXA into the joint (end surgery) VS. TXA at the start of surgery + injection af equal volume of NaCl (placebo).Primary endpoint is total blood loss 24 hours after surgery.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 18 years
- Undergoing surgery for unilateral total hip arthroplasty
- Able to give ones consent either verbally or written.
You likely can't join if
- - Operation performed in general anaesthesia
- - Patients who are not able to speak and understand Danish
- - Patients who refuse to receive blood products
- - Present acute thromboembolic event (DVT, AMI, cerebral infarction, pulmonary embolism)
- - Disseminated intravascular coagulation (DIC) or active thromboembolic disease
- - Active cancer disease
See the full eligibility criteria
- ≥ 18 years
- Undergoing surgery for unilateral total hip arthroplasty
- Able to give ones consent either verbally or written.
- - Operation performed in general anaesthesia
- - Patients who are not able to speak and understand Danish
- - Patients who refuse to receive blood products
- - Present acute thromboembolic event (DVT, AMI, cerebral infarction, pulmonary embolism)
- - Disseminated intravascular coagulation (DIC) or active thromboembolic disease
- - Active cancer disease
- - Had one of the following type of trauma or surgeries in the affected hip: Hip fractures, periacetabulær osteotomy, femurosteotomy, trochanterostetomi.
- - Rheumatic arthritis.
- - Allergi to TXA
- - In treatment with the following anticoagulatia: ADP receptorinhibitors, vitamin-K antagonist(within 5-7 days before the operation). Factor Xa inhibitors, thrombine-inhibitors
- - Use of oral anticonceptiva
- - Known with thrombophilia
- - Reduced kidney function (GFR <45 ml/hour)
- - Participated in a clinical trial within the last 30 days
- - Alcoholism and morphinism
- - Females: menstruation within the last 12 months
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.