The use of a biologic topical haemostatic agent (TachoSil®) for the prevention of postoperative bleeding in patients on antithrombotic therapy undergoing thyroid surgery

ISRCTN ISRCTN30172374
DOI https://doi.org/10.1186/ISRCTN30172374
Secondary identifying numbers N/A
Submission date
19/03/2015
Registration date
30/03/2015
Last edited
04/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
An antithrombotic drug is a drug that reduces the formation of blood clots. Patients taking oral antithrombotic drugs are frequently encountered in general surgery. Given the high risk of bleeding during or after the operation, patients may have to temporarily stop taking these drugs. However, bleeding may still occur once they restart taking the drugs. This is especially dangerous in thyroid surgery. Some topical haemostatic drugs have the ability to promote clot formation and may prevent bleeding in patients taking antithrombotic drugs. Among the available products, we decided to test TachoSil®, since it has already proved to be safe and effective in a broad range of surgical procedures. TachoSil is a sponge coated with substances that promote blood clotting. The purpose of this study was to test whether using TachoSil in patients taking antithrombotic drugs could reduce the risk of bleeding after thyroid surgery.

Who can participate?
Patients taking antithrombotic drugs, and scheduled for thyroid surgery.

What does the study involve?
Patients were randomly allocated to be treated with either standard surgical procedures or standard surgical procedures and TachoSil. Over a period of one month after the surgery, we evaluated the occurrence of bleeding, duration of drain use, hospitalization time, and complication rate.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Endocrine Surgery Unit of the University Hospital in Cagliari (Italy).

When is the study starting and how long is it expected to run for?
From November 2011 to May 2014.

Who is funding the study?
University Hospital in Cagliari (Italy).

Who is the main contact?
Assistant Professor Enrico Erdas

Contact information

Dr Enrico Erdas
Scientific

Via Mameli, 22
Cagliari
09124
Italy

ORCiD logoORCID ID 0000-0002-7674-9945

Study information

Study designSingle-centre interventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific titleThe use of a biologic topical haemostatic agent (TachoSil®) for the prevention of postoperative bleeding in patients on antithrombotic therapy undergoing thyroid surgery: a randomized controlled trial
Study objectivesThe haemostatic agent TachoSil has the ability to promote clot formation when coagulation or platelet functions are impaired. Thus we hypothesized that its use might reduce the incidence of postoperative bleeding in patients on antithrombotic treatment (with impaired coagulation)
Ethics approval(s)Institutional Ethical Committee at University Hospital of Monserrato, University of Cagliari, Italy, 03/12/2011, ref: 354/2011
Health condition(s) or problem(s) studiedPostoperative bleeding after thyroidectomy
InterventionGroup 1: patients undergoing standard surgical hemostasis (FOCUS harmonic scalpel and ligatures)
Group 2: patients for whom a patch coated with human coagulation factors (TachoSil®) was used in addition to standard procedures
Intervention typeProcedure/Surgery
Primary outcome measurePost-operative rates of cervical haematoma, that is bleeding requiring wound exploration under general anaesthesia, measured during the first post-operative month
Secondary outcome measures1. Duration of drain use
2. Postoperative hospitalization time
3. Complication rate
All measured during the first post-operative month.
Overall study start date13/11/2011
Completion date28/05/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants70
Key inclusion criteriaPatients taking vitamin K antagonists (warfarin or acenocoumarol), or acetyl salicylic acid for the prevention of thromboembolism scheduled for open total thyroidectomy
Key exclusion criteriaPatients treated with antithrombotic drugs other than vitamin K antagonists (warfarin or acenocoumarol), or scheduled for partial thyroidectomy
Date of first enrolment08/01/2012
Date of final enrolment28/05/2014

Locations

Countries of recruitment

  • Italy

Study participating centre

Endocrine Surgery Unit of the University Hospital in Cagliari
SS 554 km 4,500
Monserrato
-
Italy

Sponsor information

University of Cagliari
Hospital/treatment centre

Via Università, 40
Cagliari
09124
Italy

ROR logo "ROR" https://ror.org/003109y17

Funders

Funder type

Hospital/treatment centre

University Hospital in Cagliari (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planOne article with the main results will be submitted to a peer-reviewed journal
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2015 Yes No

Editorial Notes

04/11/2015: Publication reference added.