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 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Academic Medical Center (AMC) Department of Oral- and Maxillofacial Surgery and Department of Internal Medicine (Netherlands) |
- 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
Scientific
Academic Medical Center (AMC)
Department of Oral and Maxillofacial Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5662300 |
|---|---|
| m.h.frank@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | BLACK |
| Study objectives | Common 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) studied | Parodontitis apicalis, adult parodontitis, caries |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Peri-procedural blood loss |
| Key secondary outcome measure(s) |
1. Occurrence of thrombo-embolic events at 30 days follow-up |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 145 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
