Pathologic FibrinolysisPhase 4NCT01981863

Fibrinolysis Before Cardiopulmonary Bypass?

A Phase 4 study testing Epsilonaminocaproic acid in people with Pathologic Fibrinolysis, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects. The investigators want to show that there is no proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary bypass, and that antifibrinolytic agents should… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pathologic Fibrinolysis
What is being tested?: Epsilonaminocaproic acid
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Feb 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

All adult patients, undergoing first time sternotomy for Coronary artery bypass grafting/Aortic valve replacement/aortic surgery

Who cannot join

Resternotomy, renal insufficiency, deep hypothermia, age < 18 yrs

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Hospital & Clinics
Stanford, California, 94305

Other trials in United States

About this study

Read the detailed description

Double-blind, placebo controlled, prospective study in two groups of 20 patients. Control group (A) receives standard Epsilonaminocaproic acid treatment before cardiopulmonary bypass (10 gr loading dose, and 1 gr/hr infusion), and second group (B) receives placebo. Before start of Epsilonaminocaproic acid/placebo, D-Dimers and Thromboelastography are measured, repeated just before full heparinization. After heparinization group A receives placebo, and group B Epsilonaminocaproic acid.

Conditions: Pathologic Fibrinolysis
Being tested: Epsilonaminocaproic acid, Placebo
Keywords: cardiac surgery, cardiopulmonary bypass, fibrinolysis, thromboelastography, D-Dimers, antifibrinolytic agents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epsilonaminocaproic acidDrug
Also called Amicar
One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.
PlaceboDrug
Placebo administered in same volume as in experimental arm.

Study groups in NCT01981863
Study group	Role	What they receive
Epsilonaminocaproic acid	Experimental	One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo Receives: Drug: Epsilonaminocaproic acid
Placebo, Antifibrinolytic activity	Placebo comparator	Placebo: same IV volume as experimental arm Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Di-Dimer Increase Before Cardiopulmonary Bypass
Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.
Measured: 6 months

Secondary outcomes (1)

Value of Thromboelastography as Monitor of Fibrinolysis
Thromboelastography may display if fibrinolysis is present
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Feb 2014

First posted13 Nov 2013 (estimated)
Study startJul 2013
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pathologic FibrinolysisStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
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
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01981863
Sponsor's protocol ID: Fibrinolysis
Status last verified: Apr 2016
First submitted: 19 Sep 2013
Last updated: 30 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pathologic Fibrinolysis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fibrinolysis Before Cardiopulmonary Bypass?
ClinicalTrials.gov ID: NCT01981863
Acronym / sponsor ID: Fibrinolysis
Conditions: Pathologic Fibrinolysis
Keywords: cardiac surgery, cardiopulmonary bypass, fibrinolysis, thromboelastography, D-Dimers, antifibrinolytic agents
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Jul 2013
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 13 Nov 2013 (estimated)
Results: Posted 30 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Epsilonaminocaproic acid	Experimental	Drug: Epsilonaminocaproic acidOne arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo
Placebo, Antifibrinolytic activity	Placebo comparator	Drug: PlaceboPlacebo: same IV volume as experimental arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All adult patients, undergoing first time sternotomy for Coronary artery bypass grafting/Aortic valve replacement/aortic surgery

Key exclusion criteria (1 listed)

Resternotomy, renal insufficiency, deep hypothermia, age < 18 yrs

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
Epsilonaminocaproic acidAlso: AmicarOne group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.	Drug	Epsilonaminocaproic acid
PlaceboPlacebo administered in same volume as in experimental arm.	Drug	Placebo, Antifibrinolytic activity

Primary outcome

Di-Dimer Increase Before Cardiopulmonary Bypass
Time frame: 6 months
Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.

1 secondary outcome

Value of Thromboelastography as Monitor of Fibrinolysis
Time frame: 6 months

Results and safety

Results posted to the registry on 30 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Epsilonaminocaproic Acid	20	20
Placebo, Antifibrinolytic Activity	20	20

Primary outcome: Di-Dimer Increase Before Cardiopulmonary Bypass

Time frame: 6 months. Median (Full Range). Unit: ng/mL

Measure	Epsilonaminocaproic Acid n = 20	Placebo, Antifibrinolytic Activity n = 20
Preoperative Value	317 (200 to 2862)	266 (200 to 1224)
Immediately Before Cardiopulmonary Bypass	317 (200 to 2689)	291 (200 to 1206)
Post cardiopulmonary bypass	537 (200 to 3302)	911 (266 to 3322)

Population analysed: D-Dimer from preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Intraoperatively: From Induction to Post-Protamine administration, up to 12 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Epsilonaminocaproic Acid	0 of 20 (0%)	0 of 20 (0%)	Not reported
Placebo, Antifibrinolytic Activity	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Pieter JA Van der Starre, MD, PhD principal investigator

Stanford University

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 Epsilonaminocaproic acid in people with Pathologic Fibrinolysis, run by Stanford University at 1 site in United States.

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 1 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: finished, as of the sponsor's last update on 30 Jun 2016. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 30 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Di-Dimer Increase Before Cardiopulmonary Bypass (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01981863.

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 30 Jun 2016.