Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid

PHASE4CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

August 19, 2014

Primary Completion Date

September 26, 2016

Study Completion Date

September 26, 2016

Conditions
Intraoperative BleedingPostoperative Edema
Interventions
DRUG

Tranexamic Acid

"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."

DRUG

Saline

"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."

Trial Locations (1)

6700

Hospital of South West Denmark, Esbjerg

All Listed Sponsors
collaborator

University of Copenhagen

OTHER

collaborator

Vestjydsk Ortopædisk Fond

UNKNOWN

lead

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

NCT02229292 - Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid | Biotech Hunter | Biotech Hunter