Impact of Two Guided Transfusion Strategies on Blood Product Requirements in Liver Transplantation.
NCT04405518 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188
Last updated 2021-11-26
Summary
It is a national multicentre clinical study, where 3 hospitals are involved: Bellvitge University Hospital, Clinic Hospital of Barcelona and Cruces Hospital of Bilbao). It is a randomized study based on the Hemoglobin value of the patient with a 1:1 ratio, parallel groups, controlled and single blind, in patients undergoing an orthotopic liver transplant, confirming previously that the participants fulfill all the inclusion criteria and none of exclusion.
Conditions
- Fibrin Blood Clot
Interventions
- DRUG
-
Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]
The drug used in this study is Riastap, 1g (Fibrinogen). The dose administered will depend on the arm group assigned and in the results of the thromboelastogram during the procedure.
Sponsors & Collaborators
-
Antoni Sabaté Pes
lead OTHER
Principal Investigators
-
Marta Caballero · Bellvitge University Hospital
-
Josep Beltran · Clinic Hospital, Barcelona
-
Rosa Gutierrez · Cruces Hospital, Bilbao
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-17
- Primary Completion
- 2021-11-02
- Completion
- 2022-10-31
Countries
- Spain
Study Locations
More Related Trials
-
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
NCT02250560 ·Status: COMPLETED ·Phase: PHASE3
-
Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography
NCT03002480 ·Status: WITHDRAWN ·Phase: NA
-
Thrombin Generation Numerical Models Validation in Haemophilic Case
NCT02300519 ·Status: COMPLETED
-
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
NCT01562158 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
NCT05568719 ·Status: RECRUITING ·Phase: PHASE3
-
Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia
NCT02581735 ·Status: UNKNOWN
-
Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
NCT01029340 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes.
NCT00245297 ·Status: COMPLETED ·Phase: PHASE2
-
EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
NCT00874926 ·Status: COMPLETED
-
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
NCT01757405 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
NCT05780125 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients
NCT01563523 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors
NCT00221195 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
NCT01561391 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
NCT01564563 ·Status: TERMINATED ·Phase: PHASE2
-
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
NCT02250573 ·Status: COMPLETED ·Phase: PHASE3
-
Clot Formation and Clot Stability in Patients With Severe Haemophilia A
NCT00279578 ·Status: COMPLETED ·Phase: NA
-
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
NCT01496274 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients
NCT05020483 ·Status: WITHDRAWN ·Phase: PHASE2
-
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
NCT01575756 ·Status: COMPLETED ·Phase: PHASE2
-
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
NCT02250482 ·Status: COMPLETED ·Phase: PHASE3
-
Case-control Pilot Study of the Immune Modulating Effect of FEIBA on Patients With Haemophilia A and Inhibitors
NCT02018393 ·Status: UNKNOWN
-
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients
NCT02231944 ·Status: COMPLETED ·Phase: PHASE3
-
Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions
NCT02540434 ·Status: TERMINATED ·Phase: NA
-
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
NCT02084810 ·Status: WITHDRAWN ·Phase: PHASE1