The effect of continuation of anti-platelet agents on bleeding complications after dento-alveolar surgical procedures

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN54741248
• Date of registration: 08/03/2006
• Prospective Registration: No
• Primary sponsor: Academic Medical Centre (AMC) (Netherlands)
• Public title: The effect of continuation of anti-platelet agents on bleeding complications after dento-alveolar surgical procedures
• Date of first enrolment: 01/09/2005
• Target sample size: 145
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN54741248
• Study type: Interventional
• Study design: Randomised double blind placebo controlled parallel group trial (Treatment)

Countries of recruitment

Netherlands

Contacts

• Name: M.H. Frank

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patient on antiplatelet therapy who has to be treated in the AMC at the Department of Oral and Maxillofacial surgery
2. Approval of the prescribing physician
3. At least 18 years old
Exclusion criteria: 1. Known coagulation defect
2. Use of oral anticoagulant treatment (vitamin K antagonists) or therapeutic heparin
3. Severe kidney dysfunction (creatinine clearance <20 ml/min) or hepatic dysfunction
4. Unstable coronary artery disease
5. Patients younger than 18 years of age
6. Refusal to provide informed consent
7. Recent placement of a coronary stent (during the last 6 months)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Parodontitis apicalis, adult parodontitis, caries
Oral Health
1. Diseases of pulp and periapical tissues 2. Gingivitis and periodontal diseases 3. Dental caries

Intervention(s)

Patients will be randomised to continue their medication of anti-platelet agents during the ten days prior to the procedure or to stop treatment. The study will be double blind; hence, patients will receive their initial medication in the form of study medication or placebo in the form of study medication for ten days prior to their treatment.

Primary Outcome(s)

Peri-procedural blood loss

Secondary Outcome(s)

1. Occurrence of thrombo-embolic events at 30 days follow-up
2. The predictive effect of measurements in DNA, blood and saliva on peri-procedural hemostasis and blood loss

Secondary ID(s)

N/A

Source(s) of Monetary Support

Academic Medical Center (AMC) Department of Oral- and Maxillofacial Surgery and Department of Internal Medicine (Netherlands)