Condition category
Not Applicable
Date applied
22/09/2009
Date assigned
03/11/2009
Last edited
24/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Juergen Weitz

ORCID ID

Contact details

Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 56 6110
juergen.weitz@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

S-003/2008

Study information

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

Acronym

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

Ethics Committee of the University of Heidelberg approved on the 25th February 2008 (ref: S-003/2008)

Study design

Pilot two-armed block randomisation clinical controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Acetylsalicylic acid (aspirin)

Primary outcome measures

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 trial start date

01/01/2009

Overall trial end date

20/12/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

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

Trial participating centre

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Sponsor information

Organisation

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

Sponsor details

c/o Prof. Dr. Jürgen Weitz
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 56 6110
juergen.weitz@med.uni-heidelberg.de

Sponsor type

Hospital/treatment centre

Website

http://www.klinikum.uni-heidelberg.de/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany) - Surgical Clinical Study Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21371292
2. 2012 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/22048442

Publication citations

  1. Protocol

    Antolovic D, Reissfelder C, Rakow A, Contin P, Rahbari NN, Büchler MW, Weitz J, Koch M, A randomised controlled trial to evaluate and optimize the use of antiplatelet agents in the perioperative management in patients undergoing general and abdominal surgery--the APAP trial (ISRCTN45810007)., BMC Surg, 2011, 11, 7, doi: 10.1186/1471-2482-11-7.

  2. Pilot study

    Antolovic D, Rakow A, Contin P, Ulrich A, Rahbari NN, Büchler MW, Weitz J, Koch M, A randomised controlled pilot trial to evaluate and optimize the use of anti-platelet agents in the perioperative management in patients undergoing general and abdominal surgery--the APAP trial (ISRCTN45810007)., Langenbecks Arch Surg, 2012, 397, 2, 297-306, doi: 10.1007/s00423-011-0867-7.

Additional files

Editorial Notes