NCT05177874 is a NA clinical trial of Traumacel FAM Trium in Bleeding, sponsored by Bioster, a.s..

Who is sponsoring NCT05177874?

NCT05177874 is sponsored by Bioster, a.s..

What drugs are being tested in NCT05177874?

Interventions in NCT05177874: Traumacel FAM Trium, Surgicel Fibrillar.

What condition does NCT05177874 study?

NCT05177874 studies Bleeding, Surgical Wound.

Is NCT05177874 still recruiting?

NCT05177874 is currently completed. Last updated 5 January 2022.

Last reviewed 2022-01-05 · How we verify

NCT05177874

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Traumacel FAM Trium in the Post-market Surveillance Phase

Completed NA Last updated 5 January 2022

What this trial tests

NA trial testing Traumacel FAM Trium in Bleeding in 98 participants. Completed in 2 January 2021.

Timeline

18 May 2020

Primary endpoint
2 January 2021

2 January 2021

Quick facts

Lead sponsor	Bioster, a.s.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	98
Start date	18 May 2020
Primary completion	2 January 2021
Estimated completion	2 January 2021
Sites	1 location across Czechia

Drugs / interventions tested

Traumacel FAM Trium
Surgicel Fibrillar

Conditions studied

Bleeding — all drugs for Bleeding →
Surgical Wound — all drugs for Surgical Wound →

Sponsor

Bioster, a.s.

Who can join

Adults 18 to 120, any sex, with Bleeding or Surgical Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. It can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. The wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic). The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. The partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Bleeding

Currently open trials in the same condition.

NCT07401394 — BAR-TAX - Tranexamic Acid in Bariatric Surgery. · NA · active not recruiting
NCT07309848 — Hip Fracture Surgery Timing and Blood Transfusion Risk in Patients on DOACs · recruiting
NCT07083583 — Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders · recruiting
NCT07019077 — Incidence of Late Haemorrhage After Invasive Gastroenterological Endoscopic Manoeuvre in Patients Treated With Anticoagu · recruiting
NCT07358416 — Complications and Antiplatelet and Anticoagulant Therapy in Vascular Surgery. · active not recruiting

Other Bioster, a.s. trials

Trials by the same sponsor.

NCT05177887 — Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05177874 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bioster, a.s.
Last refreshed: 5 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05177874.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing