Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2021-006870-22-AT
EUCTR2021-006870-22-AT
Active, not recruiting
Phase 1

Substitution of coagulation factors and blood products in patients with liver cirrhosis - COUCH - Coagulation in Cirrhosis

Medical University of Vienna0 sites400 target enrollmentSeptember 13, 2022
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionsiver cirrhosisMedDRA version: 20.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Drugs- Cofact 500 IE (Prothya Biosolutions Netherlands B.V.)- Prothromplex TOTAL (Takeda (Baxter AG)1221 Wien)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
iver cirrhosis
Sponsor
Medical University of Vienna
Enrollment
400
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 13, 2022
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- liver cirrhosis
  • •\- elective micro wave ablation, radio frequency ablation, biopsy/puncture of the liver (percutaneous or transjugular), percutaneous transhepatic cholangiodrainage, transjugular intrahepatic portosystemic shunt
  • •\- INR \> 1,5 and/or PLT count \< 50 G/L
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •\- age \< 18 years
  • •\- patients unable to consent
  • •\- clinical signs or history of bleeding
  • •\- chronic kidney disease stage G4 or G5 according to KDIGO
  • •\- relevant ascites
  • •\- pregnant or breast feeding women
  • •\- not paused anticoagulant medication (except acteylsalicylic acid)

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
Evaluation of Hemostatics in coagulation inhibited human blood with viscoelastic testing (ROTEM)R58D68.9Haemorrhage, not elsewhere classifiedCoagulation defect, unspecified
DRKS00015034Bundeswehrkrankenhaus UlmKlinik für Anästhesie und IntensivmedizinSektion Notfallmedizin40
Recruiting
Not Applicable
The elucidation of the coagulation and fibrinolysis system in a cancer patients, and search of a biomarkerEsophageal cancer, Gynecological cancer, Lung cancer
JPRN-UMIN000035432Hoshigaoka Medical Cennter600
Active, not recruiting
Not Applicable
?Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF?PFM): A Phase 3/4, prospective, controlled, randomized, multi-center Study to compare the efficacy and safety of continous infusion (CI) versus intermittent bolus infusion (BI) in subjects With Severe Or Moderately Severe Hemophilia A undergoing unilateral primary total knee replacement? - Advate Randomized Surgery StudyPatients suffering from severe to moderately severe Haemophilia A (basal level of factor VIII < 2% of normal) undergoing Primary Total Unilateral Substitution of the Knee.MedDRA version: 9.1Level: LLTClassification code 10061992Term: Haemophilia
EUCTR2005-005697-71-ITBaxter Innovations GmbH60
Active, not recruiting
Phase 1
The main goal of the study is to compare the safety and effectiveness of administering ADVATE using either continuous infusion or single, large dose infusions during and post surgery for patients requiring major orthopedic surgery
EUCTR2005-005697-71-SEBaxter Innovations GmbH21
Active, not recruiting
Not Applicable
The main goal of the study is to compare the safety and effectiveness of administering ADVATE using either continuous infusion or single, large dose infusions during and post surgery for patients requiring major orthopedic surgery
EUCTR2005-005697-71-PLBaxalta Innovations GmbH21