Evidence map›Paper›PMID 39388600›Full record

Trial reportAnesthesiology2025

Protamine Dosing for Heparin Reversal after Cardiopulmonary Bypass: A Double-blinded Prospective Randomized Control Trial Comparing Two Strategies.

Pankaj Jain, Alejandra Silva-De Las Salas, Kabir Bedi, Joseph Lamelas, Richard H Epstein, Michael Fabbro

Abstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Anesthesiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. The protamine-to-heparin ratio: concept and clinical application.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2026
    Article
  2. Protamine dosing in cardiac surgery: method is key.Journal of thoracic disease · 2026
    Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Pankaj JainDepartment of Anesthesiology, Perioperative Medicine, and Pain Management, University of Miami Miller School of Medicine, Miami, Florida.
Alejandra Silva-De Las SalasDepartment of Anesthesiology, Perioperative Medicine, and Pain Management, University of Miami Miller School of Medicine, Miami, Florida.
Kabir BediUniversity of Miami, Miller School of Medicine, Miami, Florida.
Joseph LamelasDepartment of Surgery, University of Miami Miller School of Medicine, Miami, Florida.
Richard H EpsteinDepartment of Anesthesiology, Perioperative Medicine, and Pain Management, University of Miami Miller School of Medicine, Miami, Florida.
Michael FabbroDepartment of Anesthesiology, Perioperative Medicine, and Pain Management, University of Miami, Miller School of Medicine, Miami, Florida.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDrug shortages are a frequent challenge in current clinical practice. Certain drugs (e.g., protamine) lack alternatives, and inadequate supplies can limit access to services. Conventional protamine dosing uses heparin ratio-based calculations for heparin reversal after cardiopulmonary bypass and may result in excess protamine utilization and potential harm due to its intrinsic anticoagulation. This study hypothesized that a fixed 250-mg protamine dose would be comparable, as measured by the activated clotting time, to a 1:1 (1 mg for every 100 U) protamine-to-heparin ratio-based strategy for heparin reversal and that protamine would be conserved.

methodsIn a single-center, double-blinded trial, consenting elective adult cardiac surgical patients without preexisting coagulopathy or ongoing anticoagulation and a calculated initial heparin dose greater than or equal to 27,500 U were randomized to receive, after cardiopulmonary bypass, protamine as a fixed dose (250 mg) or a ratio-based dose (1 mg:100 U heparin). The primary outcome was the activated clotting time after initial protamine administration, assessed by Student's t test. Secondary outcomes included total protamine, the need for additional protamine, and the cumulative 24-h chest tube output.

resultsThere were 62 and 63 patients in the fixed- and ratio-based dose groups, respectively. The mean postprotamine activated clotting time was not different between groups (-2.0 s; 95% CI, -7.2 to 3.3 s; P = 0.47). Less total protamine per case was administered in the fixed-dose group (-2.1 50-mg vials; 95% CI, -2.4 to -1.8; P < 0.0001). There was no difference in the cumulative 24-h chest tube output (difference, -77 ml; 95% CI, 220 to 65 ml; P = 0.28).

conclusionsA 1:1 heparin ratio-based protamine dosing strategy compared to a fixed 250-mg dose resulted in the administration of a larger total dose of protamine but no difference in either the initial activated clotting time or the amount postoperative chest-tube bleeding. EDITOR’S PERSPECTIVE:

Indexed as

AnticoagulantsCardiopulmonary BypassHeparinHeparin AntagonistsProtaminesAgedDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedProspective StudiesAnticoagulantsHeparinHeparin AntagonistsProtamines

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.