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Haemocomplettan® P During Aortic Replacement

Primary Purpose

Aortic Aneurysm

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Haemocomplettan® P
Saline solution
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eighteen years of age or older
  • Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement surgery (TAA)
  • Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures
  • Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery

Exclusion Criteria:

  • Positive pregnancy test, pregnancy or lactation
  • Women of child bearing age not using a medically approved method of contraception during the study
  • Previous aortic replacement at the same aortic site (redo surgeries)
  • Undergoing an emergency operation
  • Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease)
  • Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery
  • ASA administration in the 3 days preceding study surgery, and a pathological (<74.5 U) ASPI Multiplate® test immediately preceding surgery begin
  • Clopidogrel administration in the 5 days preceding study surgery, and a pathological (<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin
  • Tirofiban administration in the 2 days preceding study surgery, and a pathological (<94.1 U) TRAP Multiplate® test immediately preceding surgery begin
  • Phenprocoumon administration in the 5 days preceding study surgery, and an INR > 1.28 immediately preceding surgery begin
  • Participation in another clinical study in the 4 weeks preceding aortic replacement
  • Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication
  • Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude)
  • Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given
  • Multiple morbidities, with a notably constrained remaining length of life

Sites / Locations

  • Medical School Hannover (MHH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Haemocomplettan® P

Saline solution

Arm Description

Intravenous infusion during aortic surgery

Outcomes

Primary Outcome Measures

Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.

Secondary Outcome Measures

Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)
Duration of stay in ICU
Duration of hospital stay
Mortality

Full Information

First Posted
June 16, 2008
Last Updated
September 18, 2013
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT00701142
Brief Title
Haemocomplettan® P During Aortic Replacement
Official Title
Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haemocomplettan® P
Arm Type
Active Comparator
Arm Description
Intravenous infusion during aortic surgery
Arm Title
Saline solution
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Haemocomplettan® P
Other Intervention Name(s)
RiaSTAP
Intervention Description
Single intravenous infusion
Intervention Type
Biological
Intervention Name(s)
Saline solution
Intervention Description
Single intravenous infusion
Primary Outcome Measure Information:
Title
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
Time Frame
From administration of Haemocomplettan® P until 24 hours later
Secondary Outcome Measure Information:
Title
Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)
Time Frame
From administration of Haemocomplettan® P until 24 hours later
Title
Duration of stay in ICU
Time Frame
Last suture of initial surgery to end of ICU stay
Title
Duration of hospital stay
Time Frame
Last suture of initial surgery to end of hospital stay
Title
Mortality
Time Frame
45 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eighteen years of age or older Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement surgery (TAA) Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery Exclusion Criteria: Positive pregnancy test, pregnancy or lactation Women of child bearing age not using a medically approved method of contraception during the study Previous aortic replacement at the same aortic site (redo surgeries) Undergoing an emergency operation Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease) Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery ASA administration in the 3 days preceding study surgery, and a pathological (<74.5 U) ASPI Multiplate® test immediately preceding surgery begin Clopidogrel administration in the 5 days preceding study surgery, and a pathological (<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin Tirofiban administration in the 2 days preceding study surgery, and a pathological (<94.1 U) TRAP Multiplate® test immediately preceding surgery begin Phenprocoumon administration in the 5 days preceding study surgery, and an INR > 1.28 immediately preceding surgery begin Participation in another clinical study in the 4 weeks preceding aortic replacement Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude) Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given Multiple morbidities, with a notably constrained remaining length of life
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Rahe-Meyer, Dr. Dr.
Organizational Affiliation
Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School Hannover (MHH)
City
Hannover
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23249928
Citation
Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sorensen B, Hagl C, Pichlmaier M. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiology. 2013 Jan;118(1):40-50. doi: 10.1097/ALN.0b013e3182715d4d. Erratum In: Anesthesiology. 2013 May;118(5):1244.
Results Reference
result
PubMed Identifier
23410777
Citation
Rahe-Meyer N, Hanke A, Schmidt DS, Hagl C, Pichlmaier M. Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: results from a randomized, placebo-controlled trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S178-85. doi: 10.1016/j.jtcvs.2012.12.083.
Results Reference
derived
PubMed Identifier
20624109
Citation
Schochl H, Posch A, Hanke A, Voelckel W, Solomon C. High-dose fibrinogen concentrate for haemostatic therapy of a major trauma patient with recent clopidogrel and aspirin intake. Scand J Clin Lab Invest. 2010 Oct;70(6):453-7. doi: 10.3109/00365513.2010.500396.
Results Reference
derived
Links:
URL
http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00701142&registryName=ctgov
Description
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Haemocomplettan® P During Aortic Replacement

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