Heart Failure,Congestive Clinical Trial
Official title:
Optimized Administration of Prothrombin Complex Concentrate (PCC) vs. Standard Transfusion During/After Heart Transplantation - OPSTAHT
This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing heart transplantation surgery. Half of the patients will receive Kcentra, while the other half will receive fresh frozen plasma.
This study will be a randomized (1:1; PCC vs. plasma), open-label trial of hemostatic therapies during heart transplantation. The goal is to enroll 60 patients. Informed consent will be obtained from patients meeting the inclusion and exclusion criteria before the initiation of any study specific procedures. Eligible patients will be randomized to receive either PCC or plasma transfusion. The efficacy of interventions will be evaluated after 30 minutes of protamine administration. After the heart transplantation, thrombocytopenia and/or hypofibrinogenemia may worsen bleeding associated with vitamin K dependent factor deficiencies. Transfusion of platelets and/or cryoprecipitate is permitted if abnormal laboratory values are observed during the rewarming phase of CPB; platelet count <100 x 103/µl, and fibrinogen <200 mg/dl, respectively. Laboratory tests (hematocrit, platelet count, PT, PTT, POC-PT, coagulation factor and inhibitor levels (e.g., factor II, antithrombin), thromboelastometry or thromboelastography, endogenous thrombin generation) will also be obtained at baseline, twice during surgery and at 12-24 hours after surgery. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03727646 -
Nicotinamide Riboside in LVAD Recipients
|
Early Phase 1 | |
| Withdrawn |
NCT03519477 -
Comprehensive Medication Monitoring on Heart Failure Patient Outcomes
|
N/A | |
| Recruiting |
NCT05596760 -
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
|
N/A | |
| Recruiting |
NCT05227872 -
PVF in Decongestion of Heart Failure
|
||
| Recruiting |
NCT05543720 -
Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study
|
N/A | |
| Completed |
NCT04572425 -
Virtual Reality for Pain Management in Advanced Heart Failure
|
N/A | |
| Recruiting |
NCT03202329 -
Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery
|
N/A | |
| Recruiting |
NCT03830957 -
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
|
N/A | |
| Recruiting |
NCT02672618 -
Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology
|
N/A | |
| Recruiting |
NCT04179643 -
NAN-101 in Patients With Class III Heart Failure
|
Phase 1 | |
| Completed |
NCT04129658 -
Heart Failure in Southern Sweden
|
||
| Not yet recruiting |
NCT05591443 -
Artificial Intelligence and Smart Wearable Technologies for Early Detection of Acute Heart Failure
|
||
| Completed |
NCT03387813 -
Hemodynamic-GUIDEd Management of Heart Failure
|
N/A | |
| Completed |
NCT04628325 -
Effects of Furosemide Plus Small HSS in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
|
Phase 3 | |
| Completed |
NCT03187470 -
Left Ventricular Dyssynchrony in Multipole Pacing
|
N/A | |
| Completed |
NCT03385837 -
Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients
|
||
| Completed |
NCT04281849 -
Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program
|
N/A | |
| Not yet recruiting |
NCT04403659 -
Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study
|
N/A | |
| Terminated |
NCT04142788 -
RELieving Increasing oEdema Due to Heart Failure
|
Phase 4 | |
| Active, not recruiting |
NCT04283994 -
Project to Improve Communication About Serious Illness--Hospital Study: Comparative Effectiveness Trial (Trial 2)
|
N/A |