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

Evaluation of intra articular Tranexamic acid for reduction of total blood loss in total hip arthroplasty

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003321-32-DK

Enrollment

100

Registered

2020-07-07

Start date

2021-01-21

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The benefit of additional Tranexamic Acid (TXA) injected intra-articular at the end of surgery for patients undergoing a unilateral total hip arthroplasty in addition to conventional IV TXA to reduce the bleeding. MedDRA version: 20.0 Level: LLT Classification code 10003397 Term: Arthroplasty of hip System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Tranexamic acid Pharmaceutical Form: Solution for injection INN or Proposed INN: Tranexamic Acid Other descriptive name: TRANEXAMIC ACID Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. ;Primary end point(s): - Total blood loss 24 hours after the operation ;Timepoint(s) of evaluation of this end point: 24 hours after the operation	—

Measure

Time frame

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. ;Primary end point(s): - Total blood loss 24 hours after the operation ;Timepoint(s) of evaluation of this end point: 24 hours after the operation

—

Secondary

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactMads Koefoed Hansen

Hvidovre Hospital, Dep. of Orthopaedic Surgery

lph821@alumni.ku.dk+4527 58 82 25

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026