Clinical trial NCT04691362: Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty
Official title: Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage Postoperative
Total Blood Loss
Arthroplasty Complications
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.

Detailed description: Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.

Eligibility criteria: Inclusion Criteria:

- ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty

Exclusion Criteria:

* Renal failure with serum creatinine level higher than 1,40 mg/dL
* Thromboembolic events in last 12 months before surgery
* Pregnancy
* Congenital or acquired coagulation diseases
* History of gastric surgery that could lead to malabsorption
* Diabetic gastro-paresis

Primary outcomes:
measure: Total blood loss
timeFrame: First 48 hours after surgery
Secondary outcomes:
measure: Serum concentration of tranexamic acid
timeFrame: 2 hours after oral administration
measure: Serum concentration of tranexamic acid
timeFrame: 6 hours after oral administration
measure: Serum concentration of tranexamic acid
timeFrame: 30 minutes after intravenous administration
measure: Serum concentration of tranexamic acid
timeFrame: 4 hours after intravenous administration
measure: Serum hemoglobin variation
timeFrame: 24 hours after surgery
measure: Serum hemoglobin variation
timeFrame: 72 hours after surgery
measure: Incidence of blood transfusion
timeFrame: 72 hours after surgery
measure: Incidence of thromboembolic complications
timeFrame: 72 hours after surgery
measure: Length of hospitalisation stay
timeFrame: 1 week after surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
References:
citation: Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. Tranexamic acid in total joint arthroplasty: the endorsed clinical practice guides of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. Reg Anesth Pain Med. 2019 Jan;44(1):7-11. doi: 10.1136/rapm-2018-000024. No abstract available.
citation: Wu Y, Zeng Y, Hu Q, Li M, Bao X, Zhong J, Shen B. Blood loss and cost-effectiveness of oral vs intravenous tranexamic acid in primary total hip arthroplasty: A randomized clinical trial. Thromb Res. 2018 Nov;171:143-148. doi: 10.1016/j.thromres.2018.10.006. Epub 2018 Oct 6.