MedTrace Logo

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

NCT02229292 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2017-03-10

No results posted yet for this study

Summary

Purpose of the study:

* To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery
* To evaluate the potential effect of TXA on fibrin structure
* To evaluate the potential effect of TXA of binding of plasminogen to fibrin
* To evaluate the potential effect of TXA on postoperative edema formation.

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

Conditions

  • Intraoperative Bleeding
  • Postoperative 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.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Vestjydsk Ortopædisk Fond

    collaborator UNKNOWN

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Principal Investigators

  • Jesper J Olsen, DDS · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-19
Primary Completion
2016-09-26
Completion
2016-09-26

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229292 on ClinicalTrials.gov