Trial · NCT00223704

Bradykinin Receptor Antagonism During Cardiopulmonary Bypass

NCT00223704, Phase 2, Phase 3, Completed, Vanderbilt University; results first posted 2013-10-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bradykinin Receptor Antagonism During Cardiopulmonary Bypass. Trials, record NCT00223704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00223704

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bradykinin Receptor Antagonism During Cardiopulmonary Bypass
NCT number: NCT00223704
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 150 participants, actual
Lead sponsor: Vanderbilt University
Conditions: Cardiopulmonary Bypass, Inflammation, Fibrinolysis, Surgery
Interventions: HOE 140, Aminocaproic Acid, Placebo
First posted: 2005-09-22
Last updated: 2013-11-25
Results first posted: 2013-10-11
Limitations and caveats: This study was conducted in a population that predominantly underwent valve-only surgery. We cannot exclude the possibility that our results may have been different if we studied only coronary artery bypass graft surgery patients.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Allogenic Blood Product Transfusion Risk	Patients were followed for the duration of hospital stay, an average of 6 days	Blood product transfusion during hospitalization that included packed red blood cells, plasma, platelets and cryoprecipitate.
Secondary	Units of Packed Red Blood Cells Transfused During Hospitalization	Patients were followed for the duration of hospital stay, an average of 6 days	Units of Packed Red Blood Cells Transfused
Secondary	Units of Plasma Transfused During Hospitalization	Patients were followed for the duration of hospital stay, an average of 6 days	Units of plasma transfused
Secondary	Inflammatory Response as Measured by Interleukin-6	Patients were followed from the start of surgery until postoperative day 2	Interleukin-6 was measured at baseline, post-bypass and on postoperative day 1 and 2.
Secondary	Fibrinolytic Response as Measured by D-dimer	Patients were followed from the start of surgery until postoperative day 1	D-dimer concentrations were measured at baseline, 30min and 60min of bypass, post-bypass and postoperative day 1

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Allogenic Blood Product Transfusion Risk	Patients were followed for the duration of hospital stay, an average of 6 days	percentage of participants	NUMBER
SECONDARY	Units of Packed Red Blood Cells Transfused During Hospitalization	Patients were followed for the duration of hospital stay, an average of 6 days	units	MEAN
SECONDARY	Units of Plasma Transfused During Hospitalization	Patients were followed for the duration of hospital stay, an average of 6 days	units	MEAN
SECONDARY	Inflammatory Response as Measured by Interleukin-6	Patients were followed from the start of surgery until postoperative day 2	pg/ml	MEAN
SECONDARY	Fibrinolytic Response as Measured by D-dimer	Patients were followed from the start of surgery until postoperative day 1	ng/ml	MEAN

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Allogenic Blood Product Transfusion Risk	Placebo Group	Received any transfusion	47.4	percentage of participants
Allogenic Blood Product Transfusion Risk	Aminocaproic Acid Group	Received any transfusion	56.8	percentage of participants
Allogenic Blood Product Transfusion Risk	HOE 140 Group	Received any transfusion	52.5	percentage of participants
Allogenic Blood Product Transfusion Risk	Placebo Group	Received packed red blood cells	36.8	percentage of participants
Allogenic Blood Product Transfusion Risk	Aminocaproic Acid Group	Received packed red blood cells	48.6	percentage of participants
Allogenic Blood Product Transfusion Risk	HOE 140 Group	Received packed red blood cells	47.5	percentage of participants
Allogenic Blood Product Transfusion Risk	Placebo Group	Received plasma	31.6	percentage of participants
Allogenic Blood Product Transfusion Risk	Aminocaproic Acid Group	Received plasma	24.3	percentage of participants
Allogenic Blood Product Transfusion Risk	HOE 140 Group	Received plasma	17.5	percentage of participants
Allogenic Blood Product Transfusion Risk	Placebo Group	Received platelets	23.7	percentage of participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Group	38
Overall Study	STARTED	Aminocaproic Acid Group	37
Overall Study	STARTED	HOE 140 Group	40
Overall Study	COMPLETED	Placebo Group	38
Overall Study	COMPLETED	Aminocaproic Acid Group	37
Overall Study	COMPLETED	HOE 140 Group	40
Overall Study	NOT COMPLETED	Placebo Group	0
Overall Study	NOT COMPLETED	Aminocaproic Acid Group	0
Overall Study	NOT COMPLETED	HOE 140 Group	0

Source ClinicalTrials.gov

Adverse events15

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Acute kidney injury	Renal and urinary disorders	Placebo Group	7	38	7
other	Acute kidney injury	Renal and urinary disorders	Aminocaproic Acid Group	4	37	4
other	Acute kidney injury	Renal and urinary disorders	HOE 140 Group	6	40	6
other	New onset postoperative atrial fibrillation	Cardiac disorders	Placebo Group	5	38	5
other	New onset postoperative atrial fibrillation	Cardiac disorders	Aminocaproic Acid Group	5	37	5
other	New onset postoperative atrial fibrillation	Cardiac disorders	HOE 140 Group	9	40	9
other	Placement of permanent pacemaker	Cardiac disorders	Placebo Group	2	38	2
other	Placement of permanent pacemaker	Cardiac disorders	Aminocaproic Acid Group	2	37	2
other	Placement of permanent pacemaker	Cardiac disorders	HOE 140 Group	3	40	3
other	Prolonged Mechanical Ventilation (>24 hours)	Respiratory, thoracic and mediastinal disorders	Placebo Group	4	38	4

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Group
Total, all-cause mortality	Aminocaproic Acid Group
Total, all-cause mortality	HOE 140 Group
Total, other adverse events	Placebo Group	15	38
Total, other adverse events	Aminocaproic Acid Group	11	37
Total, other adverse events	HOE 140 Group	18	40
Total, serious adverse events	Placebo Group	1	38
Total, serious adverse events	Aminocaproic Acid Group	1	37
Total, serious adverse events	HOE 140 Group	1	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23361105	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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