Bleeding ReductionTARGET-ANHNCT03326323

Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution

An observational study of Bleeding Reduction, run by Inova Health Care Services at 1 site in United States.

Completed

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

Trial summary

This study will help enhance current understanding of the impact of Acute Normovolemic Hemodilution (ANH) administration on transfusion requirements post cardiac surgery, the effect of this procedure on coagulation, and platelet hemostasis, and the amount of chest tube drainage 24 hours post coronary artery bypass… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Bleeding Reduction
What is being tested?: Acute Normovolemic Hemodilution
Type of treatment: Surgery or procedure
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 19 Mar 2018to 17 Oct 2019
Phase: Observational
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Study population is inclusive of both genders and all racial and ethnic groups and subgroups. Subjects will be enrolled from age 18-85 years old.

Who may be able to join

. Subject is 18-85 years old.
. Subject is hemodynamically stable
. The subject is able to read and has signed and dated the informed consent document including Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization permitting release of personal health information as approved by the investigator's Institutional Review Board (IRB).

Who cannot join

. Hematocrit <30 at baseline
. Insufficient (Low) on pump hematocrit of < 21%
. Patient is hemodynamically unstable
. Patient requiring an emergency procedure
. Left main coronary artery stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)
. Aortic valve stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)

Trial locations and contacts

1 site in 1 country.

United States1 site

Inova Heart and Vascular Institute
Falls Church, Virginia, 22042

Other trials in United States

About this study

Official title: A Pilot Study Involving the Changes in the Markers of Coagulation During Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution

Read the detailed description

Acute Normovolemic Hemodilution (ANH) involves the removal of the patients own blood immediately at the induction of anesthesia and replacement of this blood intraoperatively with an equivalent volume of crystalloid or colloid solution in order to dissuade the loss of red blood cell mass, the mechanism of action is dilution of the blood, hematocrit reduction, and reduction of the anticoagulant components of the blood associated with bleeding during cardiopulmonary bypass graft surgery. The collected blood is isolated from the negative effects of the cardiopulmonary bypass machine.. The collected blood is then stored in anticoagulant treated blood bags in the cardiovascular operating room and re-infused into the patient in reverse order of collection at the commencement of surgery, leaving the most cell rich blood to be re-infused into the patient last. This study will evaluate the effect in patients with and without ANH utilization on; hemostatic markers, chest tube drainage 24 hours post CABG, and need for allergenic blood transfusion. Positive effects on the hemostatic markers of anticoagulation and platelets, reduced chest tube drainage at 24 hours post CABG, and reduced number of transfused red blood cells will indicate a positive correlation with ANH utilization during isolated on pump CABG surgery.

The benefits of ANH utilization in blood conservation will benefit patients by reducing their exposure to allogenic blood transfusion with its myriad side effects.

Conditions: Bleeding Reduction
Being tested: Acute Normovolemic Hemodilution
Keywords: acute normovolemic hemodilution

What participants receive

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

Acute Normovolemic HemodilutionProcedure or surgery
Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.

Study groups in NCT03326323
Study group	Role	What they receive
Patients undergoing ANH during CABG		Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Receives: Procedure: Acute Normovolemic Hemodilution

What is being measured

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

Recovery in Platelet Function Post ANH
Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation.
Measured: Baseline through 24 hours post ANH procedure

Secondary outcomes (1)

Recovery in Mean Clot Firmness Post ANH
Time it takes for Mean Clot Firmness (MCF) to return normal levels post-ANH as measured by ROTEM
Measured: Baseline through 24 hours post ANH procedure

Timeline

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

19 Mar 201817 Oct 2019

First posted31 Oct 2017
Study start19 Mar 2018
Primary completion17 Sep 2019
Study completion17 Oct 2019

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 Bleeding ReductionStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03326323
Sponsor's protocol ID: 172809
Acronym: TARGET-ANH
Status last verified: Dec 2019
First submitted: 26 Oct 2017
Last updated: 13 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: 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 Bleeding Reduction trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study Involving the Changes in the Markers of Coagulation During Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
ClinicalTrials.gov ID: NCT03326323
Acronym / sponsor ID: TARGET-ANH / 172809
Conditions: Bleeding Reduction
Keywords: acute normovolemic hemodilution
Study type: Observational
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Inova Health Care ServicesUniversity, hospital or other
Collaborators: Instrumentation Laboratory
Study start: 19 Mar 2018 (actual)
Primary completion: 17 Sep 2019 (actual)
Study completion: 17 Oct 2019 (actual)
First posted: 31 Oct 2017 (actual)
Results: Posted 13 Jan 2020

Clinical summary

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

Detailed description

The benefits of ANH utilization in blood conservation will benefit patients by reducing their exposure to allogenic blood transfusion with its myriad side effects.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients undergoing ANH during CABG	–	Procedure: Acute Normovolemic HemodilutionPatients undergoing Acute Normovolemic Hemodilution during CABG surgery.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Study population is inclusive of both genders and all racial and ethnic groups and subgroups. Subjects will be enrolled from age 18-85 years old.

Key inclusion criteria (3 listed)

. Subject is 18-85 years old.
. Subject is hemodynamically stable
. The subject is able to read and has signed and dated the informed consent document including Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization permitting release of personal health information as approved by the investigator's Institutional Review Board (IRB).

Key exclusion criteria (6 listed)

. Hematocrit <30 at baseline
. Insufficient (Low) on pump hematocrit of < 21%
. Patient is hemodynamically unstable
. Patient requiring an emergency procedure
. Left main coronary artery stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)

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
Acute Normovolemic HemodilutionCollection and reinfusion of a patients own blood during coronary artery bypass graft surgery.	Procedure or surgery	Patients undergoing ANH during CABG

Primary outcome

Recovery in Platelet Function Post ANH
Time frame: Baseline through 24 hours post ANH procedure
Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation.

1 secondary outcome

Recovery in Mean Clot Firmness Post ANH
Time frame: Baseline through 24 hours post ANH procedure

Results and safety

Results posted to the registry on 13 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Undergoing ANH During CABG	43	40

Primary outcome: Recovery in Platelet Function Post ANH

Time frame: Baseline through 24 hours post ANH procedure. Mean (Standard Deviation). Unit: hours

Measure	Patients Undergoing ANH During CABG n = 40
Value	2 (30)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: in-hospital and 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Undergoing ANH During CABG	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bleeding Reduction

Enrolling by invitation
Reducing Blood Loss During Myomectomy by Comparing Local Epinephrine and Uterine Artery Tourniquet During Procedure
Local Epinephrine in Myomectomy
RecruitingObservational study
INTERACT4 Expansion - Validation Study
Intracerebral Hemorrhage
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
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Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
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RecruitingPhase 4
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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.

Eric L Sarin, MD principal investigator

Inova Heart and Vascular Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bleeding Reduction, run by Inova Health Care Services 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 3 inclusion and 6 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 13 Jan 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2020). 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?

Recovery in Platelet Function Post ANH (time frame: Baseline through 24 hours post ANH procedure). 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 NCT03326323.

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 13 Jan 2020.