Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000314527
Ethics application status
Approved
Date submitted
18/07/2006
Date registered
21/07/2006
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Date results information initially provided
11/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer
Scientific title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer
Secondary ID [1] 283 0
ClinicalTrials.gov: NCT00306137
Universal Trial Number (UTN)
Trial acronym
Bay a0128 / 11800
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer or Esophageal Cancer 1285 0
Condition category
Condition code
Cancer 1372 1372 0 0
Oesophageal (gullet)
Cancer 1373 1373 0 0
Lung - Mesothelioma
Cancer 1374 1374 0 0
Lung - Non small cell
Cancer 1375 1375 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is a randomized, double-blind, multi-center, 2 arm, parallel design study of aprotinin (Trasylol) versus placebo in subjects undergoing selected surgeries on the lung consisting of planned complete primary pneumonectomy or other pulmonary resection with high likelihood of blood transfusion, completion pneumonectomy or decortication for lung cancer, or undergoing esophagectomy (by transthoracic or transhiatal approach) for esophageal cancer. Prior to skin incision 2 million kallikrein-inhibiting units (KIU) of aprotin will be given by intravenous infusion, followed by 500,000 KIU/hour until the of surgery.
Intervention code [1] 1212 0
Prevention
Comparator / control treatment
Prior to skin incision matching placebo will be given by intravenous infusion, followed by 500,000 KIU/hour until the of surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 1876 0
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in patients undergoing surgery for lung cancer or esophageal cancer.
Timepoint [1] 1876 0
6 weeks
Secondary outcome [1] 3311 0
The number of units of blood or packed red cells transfused.
Timepoint [1] 3311 0
6 weeks
Secondary outcome [2] 3312 0
The intra-operative blood loss.
Timepoint [2] 3312 0
6 weeks
Secondary outcome [3] 3313 0
The drainage volume from the operative site.
Timepoint [3] 3313 0
6 weeks
Secondary outcome [4] 3314 0
Transfusion of platelets, colloids, plasma and number of patients requiring these products
Timepoint [4] 3314 0
6 weeks
Secondary outcome [5] 3315 0
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration.
Timepoint [5] 3315 0
6 weeks
Secondary outcome [6] 3316 0
Surgeon’s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.
Timepoint [6] 3316 0
6 weeks
Secondary outcome [7] 3317 0
Changes in blood markers related to inflammation and blood coagulation.
Timepoint [7] 3317 0
6 weeks
Secondary outcome [8] 3318 0
Time to discontinuing of mechanical ventilation.
Timepoint [8] 3318 0
6 weeks
Secondary outcome [9] 3319 0
Changes in the patients’ health related quality of life (HRQoL) measured using the Functional Assessment of cancer therapy-Esophageal Cancer (FACT-E) or Functional Assessment of cancer therapy-Lung Cancer (FACT-L) questionnaire.
Timepoint [9] 3319 0
6 weeks

Eligibility
Key inclusion criteria
Subjects requiring protocol specified oncological surgery. Subjects must have histological or cytological confirmation of malignancy in lung or esophagus.Documented, signed, dated informed consent obtained prior to any study specific procedures being performed.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with previous exposure to aprotinin in the last 6 months. Subjects with a known or suspected allergy to aprotinin.Subjects undergoing laparoscopic surgery resection.Subjects undergoing thoracoscopic resection or simple lobectomy as the planned procedure.Subjects undergoing any palliative operation.Subjects with sepsis.Subjects with mesothelioma.Subjects with impaired renal function.Subjects with a history of bleeding diathesis or known coagulation factor deficiency. Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject’s ability to complete the study or precludes the subject’s participation in the study.Subjects who refuse to receive allogenic blood products for religious or other reasons.Subjects whose preoperative red blood cell volume is so low that a blood transfusion will have to be given perioperatively.Subjects with a history of deep vein thrombosis or pulmonary embolism.Subjects who are pregnant or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening and who are not using a reliable method of contraception.Women of childbearing potential who are not using a reliable method of contraception. Use of other antifibrinolytic agents.Subjects on a chronic anti-coagulant treatment with warfarin vitamin K antagonists where it can not be discontinued presurgery for the surgical procedure.Subjects on an investigational drug in the 30 days prior to screening or during the trial before the 6 week follow-up visit. Subjects involved in trials of marketed cancer therapy medications (including those approved for another indication) or combination with radiotherapy are allowed. Subjects with known drug hypersensitivity, subjects with an allergic diathesis, and subjects who have been treated with aprotinin more than 6 month ago. For subjects for whom there is a suspicion of previous treatment with aprotinin, they may be included in the study only if precautions as outlined in the protocol are undertaken.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The packaging and dosage will be such, that the different treatment groups will appear identical. Ana interactive voice response system will be used to accomplish a blind allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
24/07/2006
Actual
20/12/2005
Date of last participant enrolment
Anticipated
Actual
24/01/2007
Date of last data collection
Anticipated
Actual
16/03/2007
Sample size
Target
696
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 1507 0
Commercial sector/Industry
Name [1] 1507 0
Bayer Australia Ltd
Country [1] 1507 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bayer Australia Limited
Address
875 Pacific Highway Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 1324 0
None
Name [1] 1324 0
Nil
Address [1] 1324 0
Country [1] 1324 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2928 0
Queen Elizabeth Hospital
Ethics committee address [1] 2928 0
Adelaide, South Australia
Ethics committee country [1] 2928 0
Australia
Date submitted for ethics approval [1] 2928 0
Approval date [1] 2928 0
03/07/2006
Ethics approval number [1] 2928 0
20060307

Summary
Brief summary
This trial is a randomized, double-blind (investigator and patient), multi-center, 2 arm, parallel design study of aprotinin (Trasylol) versus placebo in subjects undergoing selected surgeries on the lung consisting of planned complete primary pneumonectomy or other pulmonary resection with high likelihood of blood transfusion, completion pneumonectomy or decortication for lung cancer, or undergoing esophagectomy (by transthoracic or transhiatal approach) for esophageal cancer. The aprotinin or placebo will be given by intravenous infusion until the end of the surgery.
Trial website
Trial related presentations / publications
Nil known
Public notes
This was a multinational trial and global first patient enrolment occurred on 20 Dec 2005 at a site in the US where ethical approval occurred on 21 Nov 2005. First patient enrolment in Australia occurred on 11 Jan 2007.

Contacts
Principal investigator
Name 35743 0
Address 35743 0
Country 35743 0
Phone 35743 0
Fax 35743 0
Email 35743 0
Contact person for public queries
Name 10401 0
Clinical Research Manager
Address 10401 0
Bayer Australia Limited PO Box 903 Pymble NSW 2073
Country 10401 0
Australia
Phone 10401 0
02 9391 6140
Fax 10401 0
Email 10401 0
[email protected]
Contact person for scientific queries
Name 1329 0
Medical Services Manager
Address 1329 0
Bayer Australia Limited PO Box 903 Pymble NSW 2073
Country 1329 0
Australia
Phone 1329 0
02 9391 6147
Fax 1329 0
Email 1329 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.