Liver Transplant; ComplicationsPhase 4HemoCavaNCT06124209
Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial
A Phase 4 study testing TachoSil in people with Liver Transplant; Complications, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- TachoSil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 sitePoland
- Study dates
- 4 Nov 2023to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18
- elective liver transplantation
- informed consent to participate in the study
Who cannot join
- -decision to use packing during liver transplantation (bail out strategy)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of General Transplant and Liver Surgery
Warsaw, Mazovian Voivodeship, 02-097
Paweł Rykowski, MD, +48 22 599 2359, pawel.rykowski@wum.edu.pl
Maciej W Krasnodębski, PhD, MD, +48 22 599 2545, maciej.krasnodebski@wum.edu.pl
About this study
The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.
The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.
Read the detailed description
Studies have shown that materials containing fibrin shorten the time to hemostasis in the case of planned liver resection, but did not show a significant effect on the occurrence of postoperative bleeding. The aim of the study is to supplement knowledge about hemostatic matrices in liver transplantation, which will be used for the inferior vena cava anastomosis.
The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.
The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.
- Conditions
- Liver Transplant; Complications
- Being tested
- TachoSil
- Keywords
- tachosil, liver transplantation, vena cava inferior anastomosis, fibrin sealant, hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachoSilDrug
Also called fibrin sealant matrix, EU/1/04/277/001, TachoSil 9,5 x 4,8 cm, Collagen-Fibrin Patch
TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Tachosil® used in Vena Cava Inferior anastomosis | Experimental | Tachosil® used in Vena Cava Inferior anastomosis. Receives: Drug: TachoSil |
| Control | No intervention | Standard haemostatic treatment in HPB surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant postoperative bleeding
occurrence of significant postoperative bleeding within 10 days after surgery, defined as the occurrence of one of the following:
- occurrence of hematoma larger than 100ml
- transfusion of packed red blood cells after surgery
- performing relaparotomy due to bleeding
Measured: 10 days
Secondary outcomes (1)
Postoperative complication
Occurance of complication assesed in Clavien-Dindo scale
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start4 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Rykowski, Medical University of Warsaw
- Investigators
- Paweł Rykowski, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124209
- Sponsor's protocol ID
- BVI_202301
- Acronym
- HemoCava
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonimized IPD would be shared after personal contact, after PI approval
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06124209
- Acronym / sponsor ID
- HemoCava / BVI_202301
- Conditions
- Liver Transplant; Complications
- Keywords
- tachosil, liver transplantation, vena cava inferior anastomosis, fibrin sealant, hemostasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 4 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.
The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.
Detailed description
Studies have shown that materials containing fibrin shorten the time to hemostasis in the case of planned liver resection, but did not show a significant effect on the occurrence of postoperative bleeding. The aim of the study is to supplement knowledge about hemostatic matrices in liver transplantation, which will be used for the inferior vena cava anastomosis.
The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.
The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tachosil® used in Vena Cava Inferior anastomosis | Experimental | Drug: TachoSilTachosil® used in Vena Cava Inferior anastomosis. |
| Control | No intervention | –Standard haemostatic treatment in HPB surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18
- elective liver transplantation
- informed consent to participate in the study
Key exclusion criteria (1 listed)
- -decision to use packing during liver transplantation (bail out strategy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TachoSilAlso: fibrin sealant matrix, EU/1/04/277/001, TachoSil 9,5 x 4,8 cm, Collagen-Fibrin PatchTachoSil used in Vena Cava Inferior anastomosis during liver transplantation. | Drug | Tachosil® used in Vena Cava Inferior anastomosis |
Primary outcome
Significant postoperative bleeding
Time frame: 10 days
occurrence of significant postoperative bleeding within 10 days after surgery, defined as the occurrence of one of the following: 1. occurrence of hematoma larger than 100ml 2. transfusion of packed red blood cells after surgery 3. performing relaparotomy due to bleeding
1 secondary outcome
Postoperative complication
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. Anonimized IPD would be shared after personal contact, after PI approval
Related trials for Liver Transplant; Complications
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Rykowski, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TachoSil in people with Liver Transplant; Complications, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paweł Rykowski, MD (+48 22 599 2359, pawel.rykowski@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant postoperative bleeding (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.