Your session is about to expire
← Back to Search
Coagulation Factor Replacement
Prothrombin Complex Concentrate vs. Standard Transfusion for Heart Failure (OPSTAHT Trial)
Phase 3
Recruiting
Led By Kenichi Tanaka, MD
Research Sponsored by Kathirvel Subramaniam
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be at least 18 years of age.
Patients with or without ventricular assist device (VAD) undergoing heart transplantation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatment
Awards & highlights
OPSTAHT Trial Summary
This trial is testing whether Kcentra is better than standard transfusion for patients getting heart transplants.
Who is the study for?
This trial is for adults over 18 undergoing heart transplant surgery, with a body temperature above 35.0°C, blood pH over 7.2, and an INR of at least 1.5. They must have used warfarin for 72 hours before the procedure and have hemoglobin levels above 7.0 mg/dL. People with allergies to the study drugs, comprehension issues regarding the trial, life expectancy under 48 hours, recent use of certain blood thinners or clotting disorders are excluded.Check my eligibility
What is being tested?
The study compares Kcentra against fresh frozen plasma in patients having heart transplants to see which is better during and after surgery. Participants will be randomly assigned to receive either Kcentra or standard transfusion therapy.See study design
What are the potential side effects?
Kcentra might cause allergic reactions, clotting problems like deep vein thrombosis or pulmonary embolism, bleeding complications if overdosed and may carry a risk of virus transmission since it's made from human plasma.
OPSTAHT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am undergoing heart transplantation, with or without a VAD.
OPSTAHT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperatively(from start of first intervention until start of second intervention;after 2nd intervention(post-bypass)until patient out of room time) & postoperatively(from patient out of room time until 24 hours after;24 hours after until 30 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperatively(from start of first intervention until start of second intervention;after 2nd intervention(post-bypass)until patient out of room time) & postoperatively(from patient out of room time until 24 hours after;24 hours after until 30 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount of Chest Tube Drainage
Secondary outcome measures
Blood Product Use
Death
Deep Vein Thrombosis and Pulmonary Thromboembolism
+13 moreOther outcome measures
Direct Cost Benefit
Indirect Cost Benefits
Time to Intensive Care Unit (ICU) discharge
+2 moreOPSTAHT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Kcentra (PCC)Experimental Treatment1 Intervention
Half of subjects enrolled will be randomized to the Kcentra (PCC) group.
Group II: Frozen Plasma Product, HumanActive Control1 Intervention
Half of subjects enrolled will be randomized to the standard transfusion group and receive fresh frozen plasma intra-operatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kcentra
2014
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreOTHER
688 Previous Clinical Trials
374,596 Total Patients Enrolled
Kathirvel SubramaniamLead Sponsor
5 Previous Clinical Trials
782 Total Patients Enrolled
CSL BehringIndustry Sponsor
194 Previous Clinical Trials
1,211,162 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are using a machine to help you breathe, such as ECMO.I haven't taken clopidogrel, prasugrel, or ticagrelor in the last 5 days.I have not had a stroke or blood clot in the last 6 weeks.I have a condition that increases my risk of blood clots.Your blood pH is higher than 7.2.Your INR level is 1.5 or more.Your body temperature is higher than 35.0 degrees Celsius.My surgeon has decided I can't safely undergo surgery.I am 18 years old or older.I am undergoing heart transplantation, with or without a VAD.I have been taking warfarin for at least 3 days before my heart transplant surgery.Your hemoglobin level is higher than 7.0 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Frozen Plasma Product, Human
- Group 2: Kcentra (PCC)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When is it most common to give patients Kcentra?
"Kcentra is often used to treat factor x deficiency, but it can also help patients who are hemorrhaging, have hemophilia b, or need prophylaxis against perioperative bleeding due to factor x deficiency."
Answered by AI
Are new participants being accepted into the trial at this time?
"That is correct. The trial, which was posted on 2018-07-11 and updated on 2022-01-06, is currently looking for 60 patients from 3 different hospitals."
Answered by AI
How many people are filling out the paperwork for this clinical trial?
"Yes. The clinical trial is still recruiting patients, as indicated on clinicaltrials.gov. This particular study was first posted on 2018-07-11 and was last updated on 2022-01-06. They are currently recruiting for 60 patients at 3 locations."
Answered by AI
To your knowledge, is this the maiden study of this type?
"Research for Kcentra began in 2018 with a 60 person trial that was sponsored by CSL Behring. Kcentra received Phase 3 approval after the initial study and since then, there have been 12 active studies involving 34 cities and 8 countries."
Answered by AI
Could you direct me to other research that has looked into Kcentra?
"The year 2018 saw UPMC Presbyterian Shadyside conduct the first clinical trial for Kcentra. In the intervening years, a total of 83 clinical trials have completed. As of now, there are 12 active clinical trials being conducted; a majority of these are based in Baltimore, Maryland."
Answered by AI
has Kcentra undergone the necessary Food and Drug Administration evaluation for public use?
"Kcentra's safety is estimated to be a 3. This is due to the fact that Kcentra is currently in Phase 3 of clinical trials, meaning that there is both efficacy and safety data supporting its use."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger