Trial · NCT00448864

Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement

NCT00448864, Phase 2, Terminated, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2015-07-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement. Trials, record NCT00448864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00448864

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Trial

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

Title: Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
NCT number: NCT00448864
Status: Terminated
Phases: Phase 2
Enrollment: 75 participants, actual
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions: Blood Loss, Surgical
Interventions: Ecallantide, Placebo
First posted: 2007-03-19
Last updated: 2019-06-25
Results first posted: 2015-07-08

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively	Up to 12 hours post admission to intensive care unit (ICU)	Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
Secondary	Cumulative Chest Tube Drainage at 24 Hours Postoperatively	Up to 24 hours post admission to ICU	Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
Secondary	Number of Participants With Treatment-emergent Adverse Events	up to 28 days post admission to ICU	A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Secondary	Pharmacokinetics: Area Under the Concentration Time Curve	1, 2, 4, and 8 hours after end of study drug infusion	Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg\*h/L)

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively	Up to 12 hours post admission to intensive care unit (ICU)	All participants who received at least 1 dose of study drug.	Milliliters	MEAN
SECONDARY	Cumulative Chest Tube Drainage at 24 Hours Postoperatively	Up to 24 hours post admission to ICU	All participants who received at least 1 dose of study drug.	Milliliters	MEAN
SECONDARY	Number of Participants With Treatment-emergent Adverse Events	up to 28 days post admission to ICU	All participants who received at least 1 dose of study drug.	participants	NUMBER
SECONDARY	Pharmacokinetics: Area Under the Concentration Time Curve	1, 2, 4, and 8 hours after end of study drug infusion	All participants who received at least 1 dose of study drug.	mg*h/L	MEAN

Source ClinicalTrials.gov

Results by group11

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

Outcome	Group	Value	Spread	Units
Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively	Ecallantide - Low Dose Regimen	729.9	Standard Deviation 432.03	Milliliters
Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively	Ecallantide - High Dose Regimen	935.8	Standard Deviation 510.18	Milliliters
Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively	Placebo	1400.7	Standard Deviation 1371.65	Milliliters
Cumulative Chest Tube Drainage at 24 Hours Postoperatively	Ecallantide - Low Dose Regimen	82.9	Standard Deviation 74.99	Milliliters
Cumulative Chest Tube Drainage at 24 Hours Postoperatively	Ecallantide - High Dose Regimen	149.8	Standard Deviation 132.27	Milliliters
Cumulative Chest Tube Drainage at 24 Hours Postoperatively	Placebo	225.3	Standard Deviation 453.60	Milliliters
Number of Participants With Treatment-emergent Adverse Events	Ecallantide - Low Dose Regimen	25		participants
Number of Participants With Treatment-emergent Adverse Events	Ecallantide - High Dose Regimen	23		participants
Number of Participants With Treatment-emergent Adverse Events	Placebo	18		participants
Pharmacokinetics: Area Under the Concentration Time Curve	Ecallantide - Low Dose Regimen	1.39	Standard Deviation 0.589	mg*h/L

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ecallantide - Low Dose Regimen	27
Overall Study	STARTED	Ecallantide - High Dose Regimen	29
Overall Study	STARTED	Placebo	19
Overall Study	Received at Least 1 Dose of Study Drug	Ecallantide - Low Dose Regimen	26
Overall Study	Received at Least 1 Dose of Study Drug	Ecallantide - High Dose Regimen	25
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	18
Overall Study	Started Post-operative Period	Ecallantide - Low Dose Regimen	26
Overall Study	Started Post-operative Period	Ecallantide - High Dose Regimen	25
Overall Study	Started Post-operative Period	Placebo	18
Overall Study	Completed Post-operative Period	Ecallantide - Low Dose Regimen	26

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events597

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	Anaemia	Blood and lymphatic system disorders	Ecallantide - Low Dose Regimen	5	26	6
other	Anaemia	Blood and lymphatic system disorders	Ecallantide - High Dose Regimen	6	25	6
other	Anaemia	Blood and lymphatic system disorders	Placebo	6	18	6
other	Coagulopathy	Blood and lymphatic system disorders	Ecallantide - Low Dose Regimen	1	26	1
other	Coagulopathy	Blood and lymphatic system disorders	Ecallantide - High Dose Regimen	1	25	1
other	Coagulopathy	Blood and lymphatic system disorders	Placebo	0	18	0
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Ecallantide - Low Dose Regimen	1	26	1
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Ecallantide - High Dose Regimen	0	25	0
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Placebo	0	18	0
other	Haemorrhagic anaemia	Blood and lymphatic system disorders	Ecallantide - Low Dose Regimen	1	26	1

1 to 10 of 597Source ClinicalTrials.gov

See all 597 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ecallantide - Low Dose Regimen
Total, all-cause mortality	Ecallantide - High Dose Regimen
Total, all-cause mortality	Placebo
Total, other adverse events	Ecallantide - Low Dose Regimen	25	26
Total, other adverse events	Ecallantide - High Dose Regimen	23	25
Total, other adverse events	Placebo	18	18
Total, serious adverse events	Ecallantide - Low Dose Regimen	9	26
Total, serious adverse events	Ecallantide - High Dose Regimen	4	25
Total, serious adverse events	Placebo	7	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00448864

GET https://conductscience.org/api/trials/v1/NCT00448864/events?page=2

API reference For AI assistants