Perioperative management of antiplatelet agents in general and visceral surgery: a pilot study
| ISRCTN | ISRCTN45810007 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45810007 |
| Protocol serial number | S-003/2008 |
| Sponsor | University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany) |
| Funder | University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany) - Surgical Clinical Study Centre |
- Submission date
- 22/09/2009
- Registration date
- 03/11/2009
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Juergen Weitz
Scientific
Scientific
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 6110 |
|---|---|
| juergen.weitz@med.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot two-armed block randomisation clinical controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Pilot phase of a randomised controlled trial to optimise the perioperative management of antiplatelet agents in the field of general and visceral surgery |
| Study objectives | Surgery with perioperative continuation of antiplatelet agents can be safely performed without an increase of complication rates and potential decrease of thromboembolic events. |
| Ethics approval(s) | Ethics Committee of the University of Heidelberg approved on the 25th February 2008 (ref: S-003/2008) |
| Health condition(s) or problem(s) studied | Surgical complication rates, thromboembolic events |
| Intervention | In the pilot phase, we provide low-risk patients with acetylsalicylic acid (ASA) 100 mg/day. There are two arms of randomisation: discontinuation versus continuation of aspirin. Patients stop 5 days before operation and start on the 5th post-operative day again (if randomised to discontinuation) or continue the intake of aspirin. Follow-up is 30 days. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Acetylsalicylic acid (aspirin) |
| Primary outcome measure(s) |
1. Bleeding complications |
| Key secondary outcome measure(s) |
1. Duration of surgery |
| Completion date | 20/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Cardiac low and medium risk patients with antiplatelet agents 2. Informed consent 3. Aged over 18 years, either sex 4. Physical and psycological ability to participate in the trial |
| Key exclusion criteria | 1. Cardiac high risk patients 2. Psychiatric disorder 3. No informed consent |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 20/12/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/02/2012 | Yes | No | ||
| Protocol article | protocol | 03/03/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/10/2022: Internal review.
