Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Enrico Erdas
ORCID ID
http://orcid.org/0000-0002-7674-9945
Contact details
Via Mameli
22
Cagliari
09124
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The 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
Acronym
Study hypothesis
The 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
Institutional Ethical Committee at University Hospital of Monserrato, University of Cagliari, Italy, 03/12/2011, ref: 354/2011
Study design
Single-centre interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Postoperative bleeding after thyroidectomy
Intervention
Group 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 type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Post-operative rates of cervical haematoma, that is bleeding requiring wound exploration under general anaesthesia, measured during the first post-operative month
Secondary outcome measures
1. Duration of drain use
2. Postoperative hospitalization time
3. Complication rate
All measured during the first post-operative month.
Overall trial start date
13/11/2011
Overall trial end date
28/05/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Patients taking vitamin K antagonists (warfarin or acenocoumarol), or acetyl salicylic acid for the prevention of thromboembolism scheduled for open total thyroidectomy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant exclusion criteria
Patients treated with antithrombotic drugs other than vitamin K antagonists (warfarin or acenocoumarol), or scheduled for partial thyroidectomy
Recruitment start date
08/01/2012
Recruitment end date
28/05/2014
Locations
Countries of recruitment
Italy
Trial participating centre
Endocrine Surgery Unit of the University Hospital in Cagliari
SS 554 km 4,500
Monserrato
-
Italy
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital in Cagliari (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
One article with the main results will be submitted to a peer-reviewed journal
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26079499