A Phase 4 interventional study of Tranexamic Acid Oral Product and Tranexamic acid injection in Hemorrhage Postoperative, Total Blood Loss and Arthroplasty Complications, sponsored by University of Liege. Completed at 1 site in Belgium. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by University of Liege · Phase 4, Interventional, and Supportive care
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.
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 230 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →University of Liege is the lead sponsor of 242 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
128 patients scheduled for primary total hip arthroplasty
Drug: Tranexamic Acid Oral Product
128 patients scheduled for primary total hip arthroplasty
Drug: Tranexamic acid injection
Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration
Total blood loss
Peroperative (suction) and postoperative (drainage) total blood loss
Time frame: First 48 hours after surgery
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time frame: 2 hours after oral administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time frame: 6 hours after oral administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time frame: 30 minutes after intravenous administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time frame: 4 hours after intravenous administration
Serum hemoglobin variation
Variation of serum hemoglobin between preoperative and postoperative period
Time frame: 24 hours after surgery
Serum hemoglobin variation
Variation of serum hemoglobin between preoperative and postoperative period
Time frame: 72 hours after surgery
Incidence of blood transfusion
Incidence of blood transfusion in two groups
Time frame: 72 hours after surgery
Incidence of thromboembolic complications
Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis
Time frame: 72 hours after surgery
Length of hospitalisation stay
Difference between two groups of total hospitalisation days
Time frame: 1 week after surgery
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University of Liege