Trial Outcomes & Findings for Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass (NCT NCT05426031)

NCT ID: NCT05426031

Last Updated: 2024-08-13

Results Overview

Activated clotting times will be measured using standard coagulation monitor

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 130 participants
• Primary outcome timeframe: Baseline (before start of surgery)
• Results posted on: 2024-08-13

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	65	65
Overall Study COMPLETED	62	63
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	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	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
Overall Study Circulatory Arrest	3	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Fixed Dose Protamine Group n=65 Participants 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	Ratio Dose Protamine Group n=65 Participants 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	Total n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=65 Participants	0 Participants n=65 Participants	0 Participants n=130 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=65 Participants	40 Participants n=65 Participants	66 Participants n=130 Participants
Age, Categorical >=65 years	39 Participants n=65 Participants	25 Participants n=65 Participants	64 Participants n=130 Participants
Age, Continuous	66.5 years n=65 Participants	63 years n=65 Participants	64.7 years n=130 Participants
Sex: Female, Male Female	14 Participants n=65 Participants	14 Participants n=65 Participants	28 Participants n=130 Participants
Sex: Female, Male Male	51 Participants n=65 Participants	51 Participants n=65 Participants	102 Participants n=130 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline (before start of surgery)

Population: Data was collected for all subjects that completed

Activated clotting times will be measured using standard coagulation monitor

Outcome measures

Measure	Fixed Dose Protamine Group n=62 Participants 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	Ratio Dose Protamine Group n=63 Participants 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
Activated Clotting Time	116 seconds Interval 108.0 to 122.0	113 seconds Interval 107.0 to 121.0

PRIMARY outcome

Timeframe: up to 4 hours (after cardiopulmonary bypass surgery)

Population: Data was collected for all subjects that completed

Activated clotting times will be measured using standard coagulation monitor

Outcome measures

Measure	Fixed Dose Protamine Group n=62 Participants 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	Ratio Dose Protamine Group n=63 Participants 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
Activated Clotting Time	121.5 seconds Interval 114.0 to 133.0	120.5 seconds Interval 114.0 to 135.0

SECONDARY outcome

Timeframe: Up to 4 hours

Additional protamine dose will be measured in milligrams (mg)

Outcome measures

Measure	Fixed Dose Protamine Group n=62 Participants 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	Ratio Dose Protamine Group n=63 Participants 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
Additional Protamine Dosing	0 milligrams Interval 0.0 to 30.0	0 milligrams Interval 0.0 to 25.0

SECONDARY outcome

Timeframe: Up to 24 hours

Population: Data was collected for all subjects that completed

Measured in milliliters (ml)

Outcome measures

Measure	Fixed Dose Protamine Group n=62 Participants 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	Ratio Dose Protamine Group n=63 Participants 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
Chest Tube Output	640 ml Interval 500.0 to 760.0	640 ml Interval 535.0 to 840.0

SECONDARY outcome

Timeframe: Up to 4 hours

Population: Data was collected for all subjects that completed

All transfusions were recorded in a data log for the count of participants that received a red blood cell transfusion.

Outcome measures

Measure	Fixed Dose Protamine Group n=62 Participants 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	Ratio Dose Protamine Group n=63 Participants 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
Count of Participants Receiving Red Blood Cell Transfusion	2 Participants	1 Participants

Adverse Events

Fixed Dose Protamine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ratio Dose Protamine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Fabbro II, DO

University of Miami

Phone: 305-689-1106

Email: mxf790@miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place