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 prosthesi

Phase 1

Conditions: The benefit of additional Tranexamic Acid (TXA) injected intra-articularat the end of surgery for patients undergoing a unilateral total hiparthroplasty in addition to conventional IV TXA to reduce the bleeding.
MedDRA version: 20.0Level: LLTClassification code 10003397Term: Arthroplasty of hipSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2020-003321-32-DK

Lead Sponsor: Hvidovre Hospital, Dep. of Orthopaedic Surgery

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

Inclusion Criteria

= 18 years

Undergoing surgery for unilateral total hip arthroplasty

Able to give ones consent either verbally or written.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Operation performed in general anaesthesia

- 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

- Kown with thrombophilia

- Reduced kidney function (GFR <60 ml/hour)

- Participated in a clinical trial within the last 30 days

- Alcoholism and morphinism

- Females: menstruation within the last 12 months

- 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, trochanterostetoyi.

- Rheumatic arthritis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In this RCT-study we investigate the potential additive effect of intra-articular 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. ;Secondary Objective: 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.<br>;Primary end point(s): - Total blood loss 24 hours after the operation <br>;Timepoint(s) of evaluation of this end point: 24 hours after the operation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Total blood loss on the morning af the 2nd postoperative day.;Timepoint(s) of evaluation of this end point: 2nd postoperative day