Coagulation DisorderNCT03647644
Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery
An observational study of Coagulation Disorder and Bleeding, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. A unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (CPB). This unit is given back to the subject post CPB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Disorder, Bleeding
- What is being tested?
- Coagulation Laboratory Testing
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 11 Oct 2018
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects are those who are scheduled to undergo elective cardiac surgery. Researchers identify patients who based on our institutional practice would be candidates for ANH which has been shown to reduce bleeding and transfusion in cardiac surgical patients. These patients are consented to participate in the study, and are then followed through their operative day and laboratory results recorded. Patients are not randomized to any treatment arm as part of this study and it is up to the covering anesthesiologist as to whether or not a patient with undergo ANH or not (become a control).
Who may be able to join
- Undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass
- Permission to use medical records in research
Who cannot join
- Unable to grant informed consent or comply with study procedure
- Patient refusal of ANH withdrawal.
- Undergoing emergency open heart-surgery
- CPB time is expected to be < 30 minutes
- Less than 18 years of age
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. A unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (CPB). This unit is given back to the subject post CPB. This has been shown to reduce the need for blood transfusion in patients.
Read the detailed description
Subjects will be asked to allow the researchers to take the blood left over from normal standard of care blood draws and do coagulation testing. If clinically indicated, the blood, about 2 units, will be withdrawn from the subject. The researchers will also collect 8 ml (less than two teaspoons) of blood through the catheter that was placed as part of standard of care.
- Conditions
- Coagulation Disorder, Bleeding
- Being tested
- Coagulation Laboratory Testing
- Keywords
- Cardiac Surgery, Bleeding, Transfusion, Acute Normovolemic Hemodilution
- Medical subject headings
- Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coagulation Laboratory TestingDiagnostic test
Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.
| Study group | Role | What they receive |
|---|---|---|
| Acute Normovolemic Hemodilution Group | All patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. If clinically indicated and appropriate per the discretion of the anesthesiologist, Acute Normovolemic Hemodilution (ANH) blood, about 2 units, will be withdrawn from the patients and stored carefully at room temperature per standard protocol. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients prior to re-infusing the ANH blood and after the blood has been infused per standard institutional protocol. Receives: Diagnostic Test: Coagulation Laboratory Testing | |
| Control Group | All patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. In this arm, ANH would be clinically appropriate, however, the anesthesiologist determined they would not have ANH preformed. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients and again 30 minutes later to mirror the time lapse in the ANH group. Receives: Diagnostic Test: Coagulation Laboratory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet count
A platelet is a tiny piece of cell that is made by breaking off of a large cell in the bone marrow. Platelets are found in the blood and spleen. They help form blood clots to slow or stop bleeding, and to help wounds heal. Also called thrombocyte. Normal platelet count ranges from 150,000 to 450,000 platelets per microliter of blood. Units: 10(9)/L
Measured: baseline, 30 minutes after cardiopulmonary bypass
Change in Fibrinogen
Component of blood that aids in coagulation. Also known as a blood coagulation factor. Normal reference range 200-393 mg/dL.
Measured: baseline, 30 minutes after cardiopulmonary bypass
Change in Prothrombin Time/international normalized ratio (PT/INR)
Laboratory test that measures the clotting ability of blood and is a marker for the amount and functionality of the clotting factors in the blood. Normal reference range 0.9-1.1 seconds
Measured: baseline, 30 minutes after cardiopulmonary bypass
Change in aPTT
Laboratory test that measures the clotting ability of blood and is a marker for the amount and functionality of the clotting factors in the blood. Normal reference range 25-37 seconds.
Measured: baseline, 30 minutes after cardiopulmonary bypass
Change in Thromboelastogram
Laboratory test that looks at the bloods ability to form a clot and the the strength of the blood clot. It looks at all the components that allow blood to clot as a whole. The visual shape of the test along with objective data provide diagnostic information about normal or abnormal conditions of blood coagulation.
Measured: baseline, 30 minutes after cardiopulmonary bypass
Secondary outcomes (3)
Allogenic Blood Transfusion
The amount of Allogenic Blood Transfusion volume required as measured by number of transfused units of red blood cells, platelets, fresh frozen plasma, and cryoprecipitate.
Measured: 24 hours postoperative
Chest Tube Output
A marker of bleeding in cardiac surgery patients is chest tube output. The amount of fluid as measured in mL's of blood accumulated in the chest tube collection device in 24 hours.
Measured: 24 hours postoperative
Re-operation
A marker of bleeding in cardiac surgery patients is re-operation. The number of subjects who have re-operation.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start31 Jan 2018
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory A. Nuttall, M.D., Mayo Clinic
- Investigators
- Gregory Nuttall, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647644
- Sponsor's protocol ID
- 16-003298
- Status last verified
- Jan 2019
- First submitted
- 23 Aug 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03647644
- Acronym / sponsor ID
- 16-003298
- Conditions
- Coagulation Disorder, Bleeding
- Keywords
- Cardiac Surgery, Bleeding, Transfusion, Acute Normovolemic Hemodilution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. A unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (CPB). This unit is given back to the subject post CPB. This has been shown to reduce the need for blood transfusion in patients.
Detailed description
Subjects will be asked to allow the researchers to take the blood left over from normal standard of care blood draws and do coagulation testing. If clinically indicated, the blood, about 2 units, will be withdrawn from the subject. The researchers will also collect 8 ml (less than two teaspoons) of blood through the catheter that was placed as part of standard of care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Normovolemic Hemodilution Group | – | Diagnostic Test: Coagulation Laboratory TestingAll patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. If clinically indicated and appropriate per the discretion of the anesthesiologist, Acute Normovolemic Hemodilution (ANH) blood, about 2 units, will be withdrawn from the patients and stored carefully at room temperature per standard protocol. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients prior to re-infusing the ANH blood and after the blood has been infused per standard institutional protocol. |
| Control Group | – | Diagnostic Test: Coagulation Laboratory TestingAll patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. In this arm, ANH would be clinically appropriate, however, the anesthesiologist determined they would not have ANH preformed. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients and again 30 minutes later to mirror the time lapse in the ANH group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are those who are scheduled to undergo elective cardiac surgery. Researchers identify patients who based on our institutional practice would be candidates for ANH which has been shown to reduce bleeding and transfusion in cardiac surgical patients. These patients are consented to participate in the study, and are then followed through their operative day and laboratory results recorded. Patients are not randomized to any treatment arm as part of this study and it is up to the covering anesthesiologist as to whether or not a patient with undergo ANH or not (become a control).
Key inclusion criteria (2 listed)
- Undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass
- Permission to use medical records in research
Key exclusion criteria (6 listed)
- Unable to grant informed consent or comply with study procedure
- Patient refusal of ANH withdrawal.
- Undergoing emergency open heart-surgery
- CPB time is expected to be < 30 minutes
- Less than 18 years of age
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 |
|---|---|---|
| Coagulation Laboratory TestingStandard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population. | Diagnostic test | Acute Normovolemic Hemodilution Group, Control Group |
Primary outcome
Change in Platelet count
Time frame: baseline, 30 minutes after cardiopulmonary bypass
A platelet is a tiny piece of cell that is made by breaking off of a large cell in the bone marrow. Platelets are found in the blood and spleen. They help form blood clots to slow or stop bleeding, and to help wounds heal. Also called thrombocyte. Normal platelet count ranges from 150,000 to 450,000 platelets per microliter of blood. Units: 10(9)/L
Change in Fibrinogen
Time frame: baseline, 30 minutes after cardiopulmonary bypass
Component of blood that aids in coagulation. Also known as a blood coagulation factor. Normal reference range 200-393 mg/dL.
Change in Prothrombin Time/international normalized ratio (PT/INR)
Time frame: baseline, 30 minutes after cardiopulmonary bypass
Laboratory test that measures the clotting ability of blood and is a marker for the amount and functionality of the clotting factors in the blood. Normal reference range 0.9-1.1 seconds
Change in aPTT
Time frame: baseline, 30 minutes after cardiopulmonary bypass
Laboratory test that measures the clotting ability of blood and is a marker for the amount and functionality of the clotting factors in the blood. Normal reference range 25-37 seconds.
Change in Thromboelastogram
Time frame: baseline, 30 minutes after cardiopulmonary bypass
Laboratory test that looks at the bloods ability to form a clot and the the strength of the blood clot. It looks at all the components that allow blood to clot as a whole. The visual shape of the test along with objective data provide diagnostic information about normal or abnormal conditions of blood coagulation.
3 secondary outcomes
Allogenic Blood Transfusion
Time frame: 24 hours postoperative
Chest Tube Output
Time frame: 24 hours postoperative
Re-operation
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Coagulation Disorder
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 3
A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
Essential Thrombocythemia
RecruitingPhase 1
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Myeloproliferative Neoplasms
Not yet recruitingPhase 1
Lentiviral FVIII Gene Therapy
Hemophilia A
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.
Gregory Nuttall, MD principal investigator
Mayo Clinic
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 Coagulation Disorder and Bleeding, run by Mayo Clinic 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 2 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 7 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Platelet count (time frame: baseline, 30 minutes after cardiopulmonary bypass). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2019.