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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30172374

Enrollment

Registered

2015-03-30

Start date

2012-01-08

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative bleeding after thyroidectomy Surgery

Interventions

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 additi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients taking vitamin K antagonists (warfarin or acenocoumarol), or acetyl salicylic acid for the prevention of thromboembolism scheduled for open total thyroidectomy

Exclusion criteria

Exclusion criteria: Patients treated with antithrombotic drugs other than vitamin K antagonists (warfarin or acenocoumarol), or scheduled for partial thyroidectomy

Design outcomes

Secondary

Measure	Time frame
1. Duration of drain use 2. Postoperative hospitalization time 3. Complication rate All measured during the first post-operative month.	—

Primary

Measure	Time frame
Post-operative rates of cervical haematoma, that is bleeding requiring wound exploration under general anaesthesia, measured during the first post-operative month	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026