Perioperative management of antiplatelet agents in general and visceral surgery: a pilot study
| ISRCTN | ISRCTN45810007 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45810007 |
| Secondary identifying numbers | S-003/2008 |
- 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
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
| Study design | Pilot two-armed block randomisation clinical controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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) |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Acetylsalicylic acid (aspirin) |
| Primary outcome measure | 1. Bleeding complications 2. Thromboembolic events |
| Secondary outcome measures | 1. Duration of surgery 2. Blood loss during surgery 3. Complication rate 4. Length of hospital stay 5. Readmission to hospital after discharge 6. Difference between laparoscopic versus open surgery |
| Overall study start date | 01/01/2009 |
| Overall study end date | 20/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant 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 |
| Participant exclusion criteria | 1. Cardiac high risk patients 2. Psychiatric disorder 3. No informed consent |
| Recruitment start date | 01/01/2009 |
| Recruitment end date | 20/12/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof. Dr. Jürgen Weitz
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 6110 |
|---|---|
| juergen.weitz@med.uni-heidelberg.de | |
| Website | http://www.klinikum.uni-heidelberg.de/ |
"ROR" |
https://ror.org/013czdx64 |
Funders
Funder type
Hospital/treatment centre
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany) - Surgical Clinical Study Centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/03/2011 | Yes | No | |
| Results article | 01/02/2012 | Yes | No |
Editorial Notes
25/10/2022: Internal review.
