Efficacy of Tranexamic Acid for Dental Extractions in patients with Inherited Bleeding Disorders

Topical versus systemic use of Tranexamic Acid in patients with Inherited Bleeding Disorders undergoing Dental Extractions: a multicenter study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-2jx9r5

Enrollment

Unknown

Registered

2018-01-29

Start date

2016-03-09

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

von Willebrand's Disease

Interventions

Thirty-five dental extractions procedures were randomized in 26 patients with inherited bleeding disorders into two groups: 1.Study group: after the dental extraction, an 8% bioadhesive gel of tranexa

Drug

Procedure/surgery

D02.241.223.268.860

E04.545.700

Eligibility

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Adult patients (over 18 yrs old); Patients with inherited bleeding disorders; Male and females; Patients in follow up at Hemocentro de Campinas/UNICAMP and/or at Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP); Patients who need at least one tooth to be removed;

Exclusion criteria

Exclusion criteria: Patients who disagree with the terms of the informed consent; Patients who are incapable to give your own consent due to psychiatric and/or mental reasons; Under age patients (less than 18 yrs old); Pregnant women and/or breastfeeding women; Edentulous patients; 6- Hemophilic patients with inhibitors against coagulation plasmatic factors; Patients with high risk for thrombosis, or with a previous thromboembolic event; Patients who had a previous hypersensibility reaction related to tranexamic acid use; Patients who have used acetylsalicylic acid, or non-steroidal anti-inflammatory drugs up to two weeks before the dental extraction.

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: Topical use of an 8% bioadhesive gel of tranexamic acid (TXA) over the surgical wound may be effective as the standard oral use as an adjuvant therapy for bleed control in patients with inherited bleeding disorders undergoing dental extractions; The evaluation of local hemostasis was assessed after 07 days by a previous calibrated dentist, and through a daily report filled out by patients; Failure in hemostasis was considered in the presence of clinical bleeding that required a new surgical intervention and/or another replacement factor therapy dose. ;Outcome 1: Only 2/35 dental extraction procedures presented bleeding who required a new dose of coagulation factor replacement therapy and/or local reintervention. Both procedures were from the study group (p value 0.25); Topical application of an 8% bioadhesive gel of tranexamic acid as a local hemostatic method after dental extractions in patients with inherited bleeding disorders was considered safe.	—

Measure

Time frame

Expected outcome 1: Topical use of an 8% bioadhesive gel of tranexamic acid (TXA) over the surgical wound may be effective as the standard oral use as an adjuvant therapy for bleed control in patients with inherited bleeding disorders undergoing dental extractions; The evaluation of local hemostasis was assessed after 07 days by a previous calibrated dentist, and through a daily report filled out by patients; Failure in hemostasis was considered in the presence of clinical bleeding that required a new surgical intervention and/or another replacement factor therapy dose. ;Outcome 1: Only 2/35 dental extraction procedures presented bleeding who required a new dose of coagulation factor replacement therapy and/or local reintervention. Both procedures were from the study group (p value 0.25); Topical application of an 8% bioadhesive gel of tranexamic acid as a local hemostatic method after dental extractions in patients with inherited bleeding disorders was considered safe.

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Secondary

Measure	Time frame
Expected outcome 1: Topical use of an 8% bioadhesive gel of Tranexamic Acid (TXA) in patients with inherited bleeding disorders undergoing dental extractions may cause insignificant systemic biodistribution and relative biodistribution in saliva; Saliva and blood samples were collected from all patients immediately before the dental extractions and after 01 hour of the end of the dental extractions. The presence of TXA molecule in blood and saliva samples was evaluated through a Nuclear Magnetic Resonance-based methodology, using a 600 MHz HR/MAS (H-high-resolution magic angle spinning) cryoprobe. The same procedure was performed with pure tranexamic acid in order to confirm resonance assignment for this compound in plasmatic samples. The spectra processing, identification, and quantification of this compound were performed using the application package Chenomx NMR Suite, and the target profiling approach (Chenomx Inc, version 7.7, Edmonton, Canada). ;Outcome 1: The plasma levels of tranexamic acid (TXA) in the study group (8% gel of tranexamic acid) were below the limit of detection in all periods of blood collection. In the control group, the presence of TXA was found in 87.5% of pre-procedure blood samples with a mean plasma level concentration of 1.26 mg/L (0.29 to 12.1), and in 88,2% of post-procedure blood samples with a mean plasma level concentration of 0.94 mg/L (0.23 to 10.9). In saliva, the study group presented concentrations below of the detection limit pre-procedure, and the TXA was found in 94,1% of saliva samples post-procedure with a mean concentration of 42.9 mg/L (0 to 268.13 mg/L). The control group presented concentrations of TXA in saliva samples below of the detection limit in both periods.	—

Measure

Time frame

Expected outcome 1: Topical use of an 8% bioadhesive gel of Tranexamic Acid (TXA) in patients with inherited bleeding disorders undergoing dental extractions may cause insignificant systemic biodistribution and relative biodistribution in saliva; Saliva and blood samples were collected from all patients immediately before the dental extractions and after 01 hour of the end of the dental extractions. The presence of TXA molecule in blood and saliva samples was evaluated through a Nuclear Magnetic Resonance-based methodology, using a 600 MHz HR/MAS (H-high-resolution magic angle spinning) cryoprobe. The same procedure was performed with pure tranexamic acid in order to confirm resonance assignment for this compound in plasmatic samples. The spectra processing, identification, and quantification of this compound were performed using the application package Chenomx NMR Suite, and the target profiling approach (Chenomx Inc, version 7.7, Edmonton, Canada). ;Outcome 1: The plasma levels of tranexamic acid (TXA) in the study group (8% gel of tranexamic acid) were below the limit of detection in all periods of blood collection. In the control group, the presence of TXA was found in 87.5% of pre-procedure blood samples with a mean plasma level concentration of 1.26 mg/L (0.29 to 12.1), and in 88,2% of post-procedure blood samples with a mean plasma level concentration of 0.94 mg/L (0.23 to 10.9). In saliva, the study group presented concentrations below of the detection limit pre-procedure, and the TXA was found in 94,1% of saliva samples post-procedure with a mean concentration of 42.9 mg/L (0 to 268.13 mg/L). The control group presented concentrations of TXA in saliva samples below of the detection limit in both periods.

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Countries

Brazil

Contacts

Public ContactMaria Elvira;Vinicius Correa;Torregrossa

Hemocentro de Campinas/UNICAMP;Hemocentro de Campinas/UNICAMP

elvira@unicamp.br;viniciusrabelotorregrossa@gmail.com+5519982644454;+5519988059651

Outcome results

None listed

Source: REBEC (via WHO ICTRP)