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
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
Scientific
Via Mameli, 22
Cagliari
09124
Italy
 ORCID ID |
0000-0002-7674-9945 |
|---|
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 13/11/2011 |
| Completion date | 28/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Key inclusion criteria | Patients taking vitamin K antagonists (warfarin or acenocoumarol), or acetyl salicylic acid for the prevention of thromboembolism scheduled for open total thyroidectomy |
| Key exclusion criteria | Patients treated with antithrombotic drugs other than vitamin K antagonists (warfarin or acenocoumarol), or scheduled for partial thyroidectomy |
| Date of first enrolment | 08/01/2012 |
| Date of final enrolment | 28/05/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
Monserrato
-
Italy
Sponsor information
Hospital/treatment centre
Via Università, 40
Cagliari
09124
Italy
"ROR" |
https://ror.org/003109y17 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | One 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.
