NCT01530399

Brief Summary

The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the study is to define minimally effective dose of MDCO-2010.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

December 10, 2015

Completed
Last Updated

December 10, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

February 7, 2012

Results QC Date

November 4, 2015

Last Update Submit

November 4, 2015

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

  • Chest Tube Drainage at 12 Hours After Surgery

    12 hours post CABG

Study Arms (6)

MDCO 1

EXPERIMENTAL

MDCO-2010: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume

Drug: MDCO 1

MDCO 2

EXPERIMENTAL

MDCO-2010: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume

Drug: MDCO 2

MDCO 3

EXPERIMENTAL

MDCO-2010: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume

Drug: MDCO 3

MDCO 4

EXPERIMENTAL

MDCO-2010: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume

Drug: MDCO 4

Saline

PLACEBO COMPARATOR

Commercially available saline (0.9% NaCl solution)

Drug: Tranexamic Acid

Tranexamic acid

ACTIVE COMPARATOR

Tranexamic acid: 12 mg/kg loading dose; 5 mg/kg/h infusion; 0.556 mg/mL CPB priming

Drug: Saline

Interventions

MDCO 1DRUG

MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume

Also known as: MDCO-2010
MDCO 1
MDCO 2DRUG

MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume

Also known as: MDCO-2010
MDCO 2
MDCO 3DRUG

MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume

Also known as: MDCO-2010
MDCO 3
MDCO 4DRUG

MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume

Also known as: MDCO-2010
MDCO 4
Tranexamic AcidDRUG

Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.

Also known as: TXA
Saline
SalineDRUG

A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.

Also known as: NaCl 0.9%
Tranexamic acid

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Stage 1: Planned primary isolated CABG surgery
  • For Stage 2: Planned primary isolated CABG surgery, OR Planned primary combined CABG and aortic valve replacement surgery
  • Men, aged 18 to 85 years, or Women, aged 18 to 85 years, either of postmenopausal status, defined as ≥1 year since last menstrual period AND if less than 65 years old with a negative pre-operative pregnancy test within 24 hours of surgery OR with medical history of hysterectomy or bilateral oophorectomy
  • Written informed consent

You may not qualify if:

  • Off-pump surgery or hybrid procedures
  • Patients undergoing repeat sternotomy
  • Planned deep hypothermic circulatory arrest (\<28°C)
  • Known allergy, sensitivity, or contraindications to tranexamic acid
  • Epileptiform disorders, history of seizure activity, or anticonvulsive medication
  • Administration of clopidogrel, ticagrelor or ticlopidine within 5 days prior to surgery or prasugrel within 7 days prior to surgery.
  • Administration of low molecular weight heparin, glycoprotein IIb/IIIa inhibitors, or fondaparinux within 12 hours prior to surgery
  • Known history of coronary stent thrombosis within the last three months
  • History of stroke or transient ischemic attack within 3 months prior to surgery
  • History of deep venous thrombosis or pulmonary embolism
  • LVEF ≤35% or Grade III or IV
  • Body mass index \<20 or \>35
  • Known active gastrointestinal (GI) or other non-catheterization bleeding within 7 days prior to surgery
  • Preoperative coagulation abnormalities defined as:
  • Platelet count \<100,000/L or \>350,000/L, or
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Charité Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Universität Heidelberg

Heidelberg, Germany

Location

Universität Leipzig - Herzzentrum

Leipzig, Germany

Location

University Hospital/Inselspital Bern

Bern, Switzerland

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

4-(2'-hydroxy-3'-methylbut-3'-enyloxy)-8H-(1,3)dioxolo(4,5-h)chromen-8-one3-(4'-methoxybenzyl)-7,8-methylenedioxychroman-4-oneTranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Peter Villiger
Organization
TMC
peter.villiger@themedco.com
+19732906340

Study Officials

  • Lars Englberger, PD DR. med

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 10, 2015

Results First Posted

December 10, 2015

Record last verified: 2015-11

Locations

CH(1)DE(4)