Coagulation; Intravascular
Conditions
Brief summary
The purpose of this study is to compare two different dosing strategies of a drug named protamine.
Interventions
DRUGProtamine fixed dose
250 mg of protamine intravenously (IV), one time use
DRUGProtamine ratio dose
1mg of protamine per 100 units of heparin given intravenously (IV), one time use
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients greater than or equal to 18 years of age undergoing elective cardiac surgery with cardiopulmonary bypass. * Patients must that have a calculated protamine dose greater than 250 mg based on standard 1:1 initial heparin to protamine dosing calculation.
Exclusion criteria
* Patients who are under 18 years of age or pregnant. * Patients undergoing emergency surgery (ASA class E). * Patients with known coagulation disorders. * Patients requiring circulatory arrest or deep hypothermia. * Patients who have not had the appropriate interruption in coumadin, direct oral anticoagulants or non-aspirin antiplatelet agents. * Patients on pre-operative intravenous unfractionated heparin infusions. * Patients ineligible for heparin administration due to known adverse reactions including allergy or heparin induced thrombocytopenia or known heparin resistance. * Patients who are unable to provide informed consent in the form of a signature. * History of adverse reaction to protamine. * Have any condition that, in the opinion of the investigator, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activated Clotting Time | Baseline (before start of surgery) | Activated clotting times will be measured using standard coagulation monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Protamine Dosing | Up to 4 hours | Additional protamine dose will be measured in milligrams (mg) |
| Chest Tube Output | Up to 24 hours | Measured in milliliters (ml) |
| Count of Participants Receiving Red Blood Cell Transfusion | Up to 4 hours | All transfusions were recorded in a data log for the count of participants that received a red blood cell transfusion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fixed Dose Protamine Group Participants in the group will receive a one time dose of 250 mg Protamine to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery.
Protamine fixed dose: 250 mg of protamine intravenously (IV), one time use | 65 |
| Ratio Dose Protamine Group Participants in the group will receive a ratio dose of Protamine in a 1mg per 100 units of heparin ratio to reverse heparin during the standard cardiopulmonary bypass management during cardiac surgery.
Protamine ratio dose: 1mg of protamine per 100 units of heparin given intravenously (IV), one time use | 65 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Circulatory Arrest | 3 | 2 |
Baseline characteristics
| Characteristic | Fixed Dose Protamine Group | Ratio Dose Protamine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 25 Participants | 64 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 40 Participants | 66 Participants |
| Age, Continuous | 66.5 years | 63 years | 64.7 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 51 Participants | 51 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 0 / 65 | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
Primary
Activated Clotting Time
Activated clotting times will be measured using standard coagulation monitor
Time frame: Baseline (before start of surgery)
Population: Data was collected for all subjects that completed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fixed Dose Protamine Group | Activated Clotting Time | 116 seconds |
| Ratio Dose Protamine Group | Activated Clotting Time | 113 seconds |
Primary
Activated Clotting Time
Activated clotting times will be measured using standard coagulation monitor
Time frame: up to 4 hours (after cardiopulmonary bypass surgery)
Population: Data was collected for all subjects that completed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fixed Dose Protamine Group | Activated Clotting Time | 121.5 seconds |
| Ratio Dose Protamine Group | Activated Clotting Time | 120.5 seconds |
Secondary
Additional Protamine Dosing
Additional protamine dose will be measured in milligrams (mg)
Time frame: Up to 4 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fixed Dose Protamine Group | Additional Protamine Dosing | 0 milligrams |
| Ratio Dose Protamine Group | Additional Protamine Dosing | 0 milligrams |
Secondary
Chest Tube Output
Measured in milliliters (ml)
Time frame: Up to 24 hours
Population: Data was collected for all subjects that completed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fixed Dose Protamine Group | Chest Tube Output | 640 ml |
| Ratio Dose Protamine Group | Chest Tube Output | 640 ml |
Secondary
Count of Participants Receiving Red Blood Cell Transfusion
All transfusions were recorded in a data log for the count of participants that received a red blood cell transfusion.
Time frame: Up to 4 hours
Population: Data was collected for all subjects that completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Dose Protamine Group | Count of Participants Receiving Red Blood Cell Transfusion | 2 Participants |
| Ratio Dose Protamine Group | Count of Participants Receiving Red Blood Cell Transfusion | 1 Participants |