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

NCT02229292 | Completed Phase 4 DMC

• 1 other identifier: 2013-005473-52
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Intra-operative bleeding volume (ml)

  Within 10 minutes after ended surgery

Secondary Outcomes (3)

• Change in hemostatic profile

  Baseline, 5.5 hours, 48 hours and 4 months postoperatively

• Change in inflammatory profile

  Baseline, 5.5 hours, 48 hours and 4 months postoperatively

• Postoperative edema formation

  48 hours and 4 months postoperatively

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

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

Saline

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid DRUG

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

Tranexamic acid

Saline DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years or older
• Patients must be eligible for elective bi-maxillary orthognathic surgery
• No severe reduction of kidney function
• No known medical conditions
• Signed informed consent

You may not qualify if:

• Hypersensitivity to tranexamic acid
• A medical history of acute venous thrombosis and/or arterial thrombosis
• The presence of fibrinolytic conditions as a result of disseminated intravascular coagulation, with the exception of a predominant activation of the fibrinolytic system with acute severe bleeding.
• Severe kidney deficiency
• Cramps in the medical history
• Intake of Omega-3 fatty acids, Gingko Biloba, ginger and garlic supplements within 3 months of surgery.
• Pregnancy (female participants will be tested on the day of surgery)

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• University of Copenhagen: collaborator
• Vestjydsk Ortopædisk Fond: collaborator

Study Sites (1)

Hospital of South West Denmark

Esbjerg, 6700, Denmark

Location

Related Publications (1)

• Song G, Yang P, Hu J, Zhu S, Li Y, Wang Q. The effect of tranexamic acid on blood loss in orthognathic surgery: a meta-analysis of randomized controlled trials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 May;115(5):595-600. doi: 10.1016/j.oooo.2012.09.085. Epub 2012 Dec 20.

  PMID: 23260768 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jesper J Olsen, DDS

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: August 19, 2014
• Primary Completion: September 26, 2016
• Study Completion: September 26, 2016
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

DK (1)