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

ISRCTN ISRCTN54741248
DOI https://doi.org/10.1186/ISRCTN54741248
Secondary identifying numbers N/A
Submission date
08/03/2006
Registration date
08/03/2006
Last edited
19/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.H. Frank
Scientific

Academic Medical Center (AMC)
Department of Oral and Maxillofacial Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

+31 (0)20 5662300
m.h.frank@amc.uva.nl

Study information

Study designRandomised double blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymBLACK
Study objectivesCommon traditional practice until now has been discontinuation of the antiplatelet therapy 7 to 10 days prior to dental surgery, but controlled prospective data in the literature to support this practice are lacking. The discontinuation of antiplatelet treatment to ensure an adequate hemostasis during and after dental surgery needs to be offset against the (rebound) risk of thrombo-embolic complications if this treatment is stopped.
The hypothesis is that antiplatelet therapy can safely be continued prior to dental surgery.
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedParodontitis apicalis, adult parodontitis, caries
InterventionPatients 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.
Intervention typeOther
Primary outcome measurePeri-procedural blood loss
Secondary outcome measures1. 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
Overall study start date01/09/2005
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants145
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/09/2005
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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