A Phase 4 interventional study of Tranexamic Acid and Saline in Intraoperative Bleeding and Postoperative Edema, sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-10.
Sponsored by Esbjerg Hospital - University Hospital of Southern Denmark · Phase 4, Interventional, and Prevention
Purpose of the study:
Hypothesis:
H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid
H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid
The study population consists of patients referred to simultaneous mandibular and maxillary osteotomy at the Department of Oral and Maxillofacial Surgery, Hospital of South West Denmark in 2014.
Hundred patients (50 men and 50 women) will be enrolled in the study. Reportedly, the mean intraoperative blood loss in the placebo group is expected to be 436 ml with a standard deviation of 208 ml. The difference in blood loss between the TXA-group and the placebo group to be detected is 100 ml. The dropout frequency is estimated to 10%. To fulfil these assumptions a minimum of 40 patients should be included in each group to reach a power of 0.8 and an alpha of 0.05. In order to accommodate an even gender distribution a block randomization is performed resulting in the randomization of 100 patients.
The patients will be randomized to receive blindly either 10 ml tranexamic acid (100 mg/ml) (Pfizer, Ballerup, Denmark) or 10 ml saline (9mg/ml) preoperatively. Intraoperative blood loss will be determined by deducting the total volume of irrigation fluids from the volume of the contents of the surgical suction device. Postoperative edema formation will be determined by 3D surface scanning and volumetric analysis will be carried out in the "Landmarker" software.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 104 is close to the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Esbjerg Hospital - University Hospital of Southern Denmark is the lead sponsor of 45 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
The active comparator consists of an intravenously administered bolus injection of 10ml of 100mg/ml tranexamic (1g in total) given as a single dose, after the onset of anesthesia, prior to surgery.
Drug: Tranexamic Acid
The placebo consists of an intravenously administered bolus injection of 10 ml of 9mg/ml sodium chloride given as a single dose after the onset of anesthesia, prior to surgery.
Drug: Saline
Active group: Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml tranexamic acid (100mg/ml) administered iv. prior to the onset of the surgical procedure.
Also known as: Tranexamsyre "Pfizer", D.SP.NR.: 22646, ATC code: B 02 AA 02
Placebo group: Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml sodium chloride (9mg/ml) administered iv. prior to the onset of the surgical procedure.
Also known as: Natriumklorid "B. Braun", D.SP.NR.: 6856, ATC code: V 07 AB
Intra-operative bleeding volume (ml)
Time frame: Within 10 minutes after ended surgery
Change in hemostatic profile
Changes in the hemostatic profile measured through thrombelastography, thrombin generation test and fibrin structure analysis.
Time frame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Change in inflammatory profile
Changes in the inflammatory profile are investigated through measures of surface induced activation, inflammation and plasminogen binding.
Time frame: Baseline, 5.5 hours, 48 hours and 4 months postoperatively
Postoperative edema formation
The degree of postoperative swelling in connection with TXA /or not, is determined by non-invasive 3D face scans and quantified using the "Landmarker" software. Scans are carried out along with the 3rd and 4th blood samples, 48 hours and 4 months postoperatively.
Time frame: 48 hours and 4 months postoperatively
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Esbjerg Hospital - University Hospital of Southern Denmark