Condition category
Surgery
Date applied
19/03/2015
Date assigned
30/03/2015
Last edited
04/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

University of Cagliari

Sponsor details

Via Università
40
Cagliari
09124
Italy

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

04/11/2015: Publication reference added.