Phase 4
Completed N=130
Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass
Coagulation; Intravascular
Source: ClinicalTrials.gov NCT05426031 ↗
Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Activated Clotting Time — 116; 113 seconds
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare two different dosing strategies of a drug named protamine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Activated Clotting Time |
121.5; 120.5 | — |
| SECONDARY Additional Protamine Dosing |
0; 0 | — |
| SECONDARY Chest Tube Output |
640; 640 | — |
| SECONDARY Count of Participants Receiving Red Blood Cell Transfusion |
2; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05426031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.