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TASALL - TachoSil® Against Liquor Leak

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ClinicalTrials.gov Identifier: NCT01355627
Recruitment Status : Completed
First Posted : May 18, 2011
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cerebrospinal Fluid Leaks
Interventions Procedure: TachoSil®
Procedure: Current Practice
Enrollment 726
Recruitment Details Participants took part in the study at thirty-five Centres in a total of 10 countries: Belgium, France, Germany, Greece, Italy The Netherlands, Poland, Russia, Spain and Sweden from 28 April 2011 to 27 June 2013.
Pre-assignment Details Participants requiring dura sealing techniques for the prevention of post-operative cerebrospinal fluid (CSF) leaks were enrolled; 726 participants were randomized equally in 1 of 2 treatment groups, TachoSil® or Current practice group.
Arm/Group Title TachoSil® Current Practice Group
Hide Arm/Group Description Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura. Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
Period Title: Overall Study
Started 362 364
Safety Analysis Set 362 364
Full Analysis Set 361 [1] 365 [2]
Completed 329 326
Not Completed 33 38
Reason Not Completed
Request By the Patient to Discontinue             5             7
Lost to Follow-up             8             7
Fatal Adverse Event             19             23
Other             1             1
[1]
One participant's data for final follow-up is missing, completion status could not be confirmed.
[2]
One participant randomized to Current Practice actually received TachoSil®.
Arm/Group Title TachoSil® Current Practice Group Total
Hide Arm/Group Description Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura. Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®. Total of all reporting groups
Overall Number of Baseline Participants 361 365 726
Hide Baseline Analysis Population Description
Baseline Measures were based on the Full Analysis Set that included all enrolled randomized patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 361 participants 365 participants 726 participants
53.1  (13.80) 53.2  (14.22) 53.1  (14.00)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 361 participants 365 participants 726 participants
18-65 years 288 293 581
>65 years 73 72 145
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 365 participants 726 participants
Female
233
  64.5%
211
  57.8%
444
  61.2%
Male
128
  35.5%
154
  42.2%
282
  38.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 361 participants 365 participants 726 participants
White/Caucasian 355 361 716
Asian 1 0 1
Black or African American 3 2 5
American Indian or Alaska Native 1 1 2
Other 1 1 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 361 participants 365 participants 726 participants
Hispanic or Latino 55 62 117
Non-Hispanic and Non-Latino 295 289 584
Unknown 11 14 25
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 361 participants 365 participants 726 participants
Belgium 87 87 174
Germany 33 29 62
Spain 54 54 108
France 24 26 50
Greece 34 38 72
Italy 14 14 28
Netherlands 3 2 5
Poland 59 61 120
Russian Federation 9 8 17
Sweden 44 46 90
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 361 participants 365 participants 726 participants
167.4  (9.44) 168.5  (9.18) 168.0  (9.32)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 361 participants 365 participants 726 participants
73.6  (14.40) 75.2  (16.79) 74.4  (15.65)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 361 participants 365 participants 726 participants
26.20  (4.44) 26.42  (5.10) 26.31  (4.79)
Fertility Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 361 participants 365 participants 726 participants
Fertile 74 74 148
Post-Menopausal 140 111 251
Surgically Sterile 19 26 45
Not Applicable 128 154 282
1.Primary Outcome
Title Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure
Hide Description An assessment was performed daily from randomization to Day of Discharge and at the Efficacy Follow-up visit at week 7 ± 1 week. Clinically evident cerebrospinal fluid leak was confirmed by: 1. Glucose concentration test and/or 2. β-2-transferrin test. A clinically evident pseudomeningocele was considered to be present post-operatively if the following criteria were fulfilled: 1. A subcutaneous, visible/palpable fluctuant fluid accumulation was noted at the site of the surgical incision or adjacent to it; 2. It is suspected the fluid accumulation is cerebrospinal fluid. A treatment failure was defined as application of a new and/or different treatment after application of the study treatment or a third application of (or part of) the selected study treatment on the outside of the dura.
Time Frame Up to 8 Weeks (7 Weeks ± 1 Week)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population included all enrolled randomized patients.
Arm/Group Title TachoSil® Current Practice Group
Hide Arm/Group Description:
Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
Overall Number of Participants Analyzed 361 365
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.9
(4.5 to 10.1)
8.2
(5.6 to 11.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TachoSil®, Current Practice Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.485
Comments [Not Specified]
Method Regression, Logistic
Comments Treatment and pooled centre as covariates.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments < 1 implies a smaller likelihood of a TachoSil treated patient to experience a CSF leak.
2.Secondary Outcome
Title Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele
Hide Description Non-clinically evident pseudomeningocele was defined as a cerebrospinal fluid accumulation found on a postoperative computerized tomography (CT) or magnetic resonance imaging (MRI) scan which fulfilled the following criteria according to the radiologist assessment before Day of Discharge: CT Scan-Fluid accumulation seen as Hypodense signal, MRI Scan-Fluid accumulation seen as Hypointense signal in T1-weighted image and/ OR Fluid accumulation seen as Hyperintense signal in T2-weighted image.
Time Frame Assessment at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days (Up to 28 Weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population included all enrolled randomized patients.
Arm/Group Title TachoSil® Current Practice Group
Hide Arm/Group Description:
Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
Overall Number of Participants Analyzed 361 365
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.0
(1.5 to 5.4)
3.0
(1.5 to 5.3)
Time Frame Safety data were collected from when the patient signed the Informed Consent Form (ICF) until the Safety Follow-up (Up to 28 weeks)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title TachoSil® Current Practice Group
Hide Arm/Group Description Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura. Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
All-Cause Mortality
TachoSil® Current Practice Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TachoSil® Current Practice Group
Affected / at Risk (%) Affected / at Risk (%)
Total   94/362 (25.97%)   97/364 (26.65%) 
Blood and lymphatic system disorders     
Anaemia  1  1/362 (0.28%)  4/364 (1.10%) 
Cardiac disorders     
Cardio-respiratory arrest  1  2/362 (0.55%)  0/364 (0.00%) 
Myocardial infarction  1  1/362 (0.28%)  0/364 (0.00%) 
Atrial fibrillation  1  0/362 (0.00%)  2/364 (0.55%) 
Bradycardia  1  0/362 (0.00%)  1/364 (0.27%) 
Cardiac arrest  1  0/362 (0.00%)  1/364 (0.27%) 
Myocardial ischaemia  1  0/362 (0.00%)  1/364 (0.27%) 
Ear and labyrinth disorders     
Otorrhoea  1  1/362 (0.28%)  0/364 (0.00%) 
Deafness unilateral  1  0/362 (0.00%)  2/364 (0.55%) 
Vertigo  1  0/362 (0.00%)  1/364 (0.27%) 
Endocrine disorders     
Inappropriate antidiuretic hormone secretion  1  1/362 (0.28%)  0/364 (0.00%) 
Diabetes insipidus  1  0/362 (0.00%)  1/364 (0.27%) 
Eye disorders     
Diplopia  1  0/362 (0.00%)  1/364 (0.27%) 
Vision blurred  1  0/362 (0.00%)  1/364 (0.27%) 
Visual impairment  1  0/362 (0.00%)  1/364 (0.27%) 
Gastrointestinal disorders     
Vomiting  1  3/362 (0.83%)  0/364 (0.00%) 
Abdominal pain upper  1  1/362 (0.28%)  0/364 (0.00%) 
Constipation  1  1/362 (0.28%)  0/364 (0.00%) 
Dysphagia  1  1/362 (0.28%)  0/364 (0.00%) 
Nausea  1  1/362 (0.28%)  0/364 (0.00%) 
Diarrhoea  1  0/362 (0.00%)  1/364 (0.27%) 
Rectal haemorrhage  1  0/362 (0.00%)  1/364 (0.27%) 
General disorders     
Asthenia  1  1/362 (0.28%)  0/364 (0.00%) 
Device malfunction  1  1/362 (0.28%)  0/364 (0.00%) 
Drug effect decreased  1  1/362 (0.28%)  0/364 (0.00%) 
General physical health deterioration  1  1/362 (0.28%)  0/364 (0.00%) 
Spinal pain  1  1/362 (0.28%)  0/364 (0.00%) 
Death  1  0/362 (0.00%)  3/364 (0.82%) 
Oedema peripheral  1  0/362 (0.00%)  1/364 (0.27%) 
Pyrexia  1  0/362 (0.00%)  4/364 (1.10%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/362 (0.28%)  0/364 (0.00%) 
Infections and infestations     
Pneumonia  1  6/362 (1.66%)  7/364 (1.92%) 
Meningitis  1  5/362 (1.38%)  3/364 (0.82%) 
Sepsis  1  3/362 (0.83%)  5/364 (1.37%) 
Septic shock  1  2/362 (0.55%)  1/364 (0.27%) 
Bacterial disease carrier  1  1/362 (0.28%)  0/364 (0.00%) 
Brain abscess  1  1/362 (0.28%)  0/364 (0.00%) 
Candida sepsis  1  1/362 (0.28%)  0/364 (0.00%) 
Central nervous system infection  1  1/362 (0.28%)  0/364 (0.00%) 
Osteomyelitis  1  1/362 (0.28%)  0/364 (0.00%) 
Peritonitis  1  1/362 (0.28%)  0/364 (0.00%) 
Postoperative wound infection  1  1/362 (0.28%)  0/364 (0.00%) 
Respiratory tract infection  1  1/362 (0.28%)  0/364 (0.00%) 
Staphylococcal sepsis  1  1/362 (0.28%)  0/364 (0.00%) 
Subdural empyema  1  1/362 (0.28%)  0/364 (0.00%) 
Urinary tract infection  1  1/362 (0.28%)  2/364 (0.55%) 
Urinary tract infection bacterial  1  1/362 (0.28%)  0/364 (0.00%) 
Urosepsis  1  1/362 (0.28%)  0/364 (0.00%) 
Wound infection  1  1/362 (0.28%)  1/364 (0.27%) 
Acinetobacter bacteraemia  1  0/362 (0.00%)  1/364 (0.27%) 
Endocarditis  1  0/362 (0.00%)  1/364 (0.27%) 
Escherichia urinary tract infection  1  0/362 (0.00%)  1/364 (0.27%) 
Gastroenteritis  1  0/362 (0.00%)  1/364 (0.27%) 
Lobar pneumonia  1  0/362 (0.00%)  1/364 (0.27%) 
Lung infection  1  0/362 (0.00%)  1/364 (0.27%) 
Meningitis aseptic  1  0/362 (0.00%)  4/364 (1.10%) 
Meningitis bacterial  1  0/362 (0.00%)  3/364 (0.82%) 
Meningitis staphylococcal  1  0/362 (0.00%)  1/364 (0.27%) 
Oropharyngitis fungal  1  0/362 (0.00%)  1/364 (0.27%) 
Otitis media  1  0/362 (0.00%)  1/364 (0.27%) 
Pneumonia klebsiella  1  0/362 (0.00%)  1/364 (0.27%) 
Postoperative abscess  1  0/362 (0.00%)  1/364 (0.27%) 
Pseudomonas infection  1  0/362 (0.00%)  1/364 (0.27%) 
Salmonellosis  1  0/362 (0.00%)  1/364 (0.27%) 
Staphylococcal infection  1  0/362 (0.00%)  1/364 (0.27%) 
Injury, poisoning and procedural complications     
Post procedural haematoma  1  2/362 (0.55%)  1/364 (0.27%) 
Subdural haematoma  1  2/362 (0.55%)  1/364 (0.27%) 
Endotracheal intubation complication  1  1/362 (0.28%)  0/364 (0.00%) 
Femur fracture  1  1/362 (0.28%)  0/364 (0.00%) 
Incision site haemorrhage  1  1/362 (0.28%)  0/364 (0.00%) 
Post procedural haemorrhage  1  1/362 (0.28%)  1/364 (0.27%) 
Posterior fossa syndrome  1  1/362 (0.28%)  0/364 (0.00%) 
Pseudomeningocele  1  1/362 (0.28%)  1/364 (0.27%) 
Shunt malfunction  1  1/362 (0.28%)  0/364 (0.00%) 
Spinal compression fracture  1  1/362 (0.28%)  0/364 (0.00%) 
Ankle fracture  1  0/362 (0.00%)  1/364 (0.27%) 
Brain herniation  1  0/362 (0.00%)  3/364 (0.82%) 
Cervical vertebral fracture  1  0/362 (0.00%)  1/364 (0.27%) 
Incision site haematoma  1  0/362 (0.00%)  2/364 (0.55%) 
Post lumbar puncture syndrome  1  0/362 (0.00%)  1/364 (0.27%) 
Procedural haemorrhage  1  0/362 (0.00%)  1/364 (0.27%) 
Seroma  1  0/362 (0.00%)  1/364 (0.27%) 
Wound dehiscence  1  0/362 (0.00%)  1/364 (0.27%) 
Investigations     
Weight decreased  1  1/362 (0.28%)  0/364 (0.00%) 
Escherichia test positive  1  0/362 (0.00%)  1/364 (0.27%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  1/362 (0.28%)  0/364 (0.00%) 
Hyperglycaemia  1  1/362 (0.28%)  0/364 (0.00%) 
Hyponatraemia  1  1/362 (0.28%)  0/364 (0.00%) 
Decreased appetite  1  0/362 (0.00%)  1/364 (0.27%) 
Hypovitaminosis  1  0/362 (0.00%)  1/364 (0.27%) 
Pancreatogenous diabetes  1  0/362 (0.00%)  1/364 (0.27%) 
Musculoskeletal and connective tissue disorders     
Muscle atrophy  1  1/362 (0.28%)  0/364 (0.00%) 
Back pain  1  0/362 (0.00%)  2/364 (0.55%) 
Muscle spasms  1  0/362 (0.00%)  1/364 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm progression  1  3/362 (0.83%)  3/364 (0.82%) 
Neoplasm recurrence  1  2/362 (0.55%)  1/364 (0.27%) 
Central nervous system lymphoma  1  1/362 (0.28%)  1/364 (0.27%) 
Cerebellar tumour  1  1/362 (0.28%)  0/364 (0.00%) 
Glioblastoma  1  1/362 (0.28%)  0/364 (0.00%) 
Glioblastoma multiforme  1  1/362 (0.28%)  0/364 (0.00%) 
Lung cancer metastatic  1  1/362 (0.28%)  0/364 (0.00%) 
Malignant neoplasm progression  1  1/362 (0.28%)  1/364 (0.27%) 
Meningioma  1  1/362 (0.28%)  0/364 (0.00%) 
Metastases to central nervous system  1  1/362 (0.28%)  1/364 (0.27%) 
Metastases to lung  1  1/362 (0.28%)  0/364 (0.00%) 
Neoplasm  1  1/362 (0.28%)  0/364 (0.00%) 
Pituitary tumour benign  1  1/362 (0.28%)  0/364 (0.00%) 
Uterine leiomyoma  1  1/362 (0.28%)  0/364 (0.00%) 
Acoustic neuroma  1  0/362 (0.00%)  1/364 (0.27%) 
Anaplastic astrocytoma  1  0/362 (0.00%)  1/364 (0.27%) 
Cerebellopontine angle tumour  1  0/362 (0.00%)  1/364 (0.27%) 
Lymphoma  1  0/362 (0.00%)  1/364 (0.27%) 
Metastases to meninges  1  0/362 (0.00%)  1/364 (0.27%) 
Schwannoma  1  0/362 (0.00%)  1/364 (0.27%) 
Nervous system disorders     
Hydrocephalus  1  10/362 (2.76%)  8/364 (2.20%) 
Cerebral ischaemia  1  4/362 (1.10%)  2/364 (0.55%) 
Cerebrospinal fluid leakage  1  4/362 (1.10%)  4/364 (1.10%) 
Brain oedema  1  3/362 (0.83%)  1/364 (0.27%) 
Facial paresis  1  3/362 (0.83%)  1/364 (0.27%) 
Brain stem haematoma  1  2/362 (0.55%)  0/364 (0.00%) 
Cerebellar haematoma  1  2/362 (0.55%)  0/364 (0.00%) 
Cerebral infarction  1  2/362 (0.55%)  3/364 (0.82%) 
Cerebral vasoconstriction  1  2/362 (0.55%)  2/364 (0.55%) 
Cerebrovascular accident  1  2/362 (0.55%)  1/364 (0.27%) 
VIIth nerve paralysis  1  2/362 (0.55%)  1/364 (0.27%) 
Altered state of consciousness  1  1/362 (0.28%)  0/364 (0.00%) 
Anosmia  1  1/362 (0.28%)  1/364 (0.27%) 
Aphasia  1  1/362 (0.28%)  0/364 (0.00%) 
Convulsion  1  1/362 (0.28%)  1/364 (0.27%) 
Dementia  1  1/362 (0.28%)  0/364 (0.00%) 
Dyskinesia  1  1/362 (0.28%)  0/364 (0.00%) 
Epilepsy  1  1/362 (0.28%)  2/364 (0.55%) 
Haemorrhagic cerebral infarction  1  1/362 (0.28%)  0/364 (0.00%) 
Hemiparesis  1  1/362 (0.28%)  3/364 (0.82%) 
IIIrd nerve paralysis  1  1/362 (0.28%)  0/364 (0.00%) 
Intracranial haematoma  1  1/362 (0.28%)  2/364 (0.55%) 
Intracranial pressure increased  1  1/362 (0.28%)  0/364 (0.00%) 
Ischaemic stroke  1  1/362 (0.28%)  1/364 (0.27%) 
Paraesthesia  1  1/362 (0.28%)  0/364 (0.00%) 
Partial seizures  1  1/362 (0.28%)  0/364 (0.00%) 
Pneumocephalus  1  1/362 (0.28%)  0/364 (0.00%) 
Polyneuropathy  1  1/362 (0.28%)  0/364 (0.00%) 
Quadriparesis  1  1/362 (0.28%)  1/364 (0.27%) 
Status epilepticus  1  1/362 (0.28%)  0/364 (0.00%) 
Subarachnoid haemorrhage  1  1/362 (0.28%)  2/364 (0.55%) 
Subdural hygroma  1  1/362 (0.28%)  0/364 (0.00%) 
Trigeminal neuralgia  1  1/362 (0.28%)  1/364 (0.27%) 
Brain stem infarction  1  0/362 (0.00%)  1/364 (0.27%) 
Brain stem stroke  1  0/362 (0.00%)  1/364 (0.27%) 
Bulbar palsy  1  0/362 (0.00%)  1/364 (0.27%) 
Cerebellar haemorrhage  1  0/362 (0.00%)  1/364 (0.27%) 
Cerebral haematoma  1  0/362 (0.00%)  3/364 (0.82%) 
Cerebral haemorrhage  1  0/362 (0.00%)  1/364 (0.27%) 
Cranial nerve palsies multiple  1  0/362 (0.00%)  1/364 (0.27%) 
Cranial nerve paralysis  1  0/362 (0.00%)  1/364 (0.27%) 
Encephalitis  1  0/362 (0.00%)  1/364 (0.27%) 
Grand mal convulsion  1  0/362 (0.00%)  2/364 (0.55%) 
Headache  1  0/362 (0.00%)  2/364 (0.55%) 
Hemianopia  1  0/362 (0.00%)  1/364 (0.27%) 
Hypoglossal nerve paresis  1  0/362 (0.00%)  1/364 (0.27%) 
Intracranial aneurysm  1  0/362 (0.00%)  1/364 (0.27%) 
Memory impairment  1  0/362 (0.00%)  1/364 (0.27%) 
Sciatica  1  0/362 (0.00%)  1/364 (0.27%) 
Sedation  1  0/362 (0.00%)  1/364 (0.27%) 
Syncope  1  0/362 (0.00%)  1/364 (0.27%) 
Vertebral artery stenosis  1  0/362 (0.00%)  1/364 (0.27%) 
Psychiatric disorders     
Depressed mood  1  1/362 (0.28%)  0/364 (0.00%) 
Renal and urinary disorders     
Renal cyst  1  0/362 (0.00%)  1/364 (0.27%) 
Renal disorder  1  0/362 (0.00%)  1/364 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  2/362 (0.55%)  0/364 (0.00%) 
Dysphonia  1  1/362 (0.28%)  0/364 (0.00%) 
Hiccups  1  1/362 (0.28%)  0/364 (0.00%) 
Laryngeal oedema  1  1/362 (0.28%)  0/364 (0.00%) 
Lung disorder  1  1/362 (0.28%)  0/364 (0.00%) 
Pneumonia aspiration  1  1/362 (0.28%)  0/364 (0.00%) 
Pulmonary thrombosis  1  1/362 (0.28%)  0/364 (0.00%) 
Acute respiratory distress syndrome  1  0/362 (0.00%)  1/364 (0.27%) 
Atelectasis  1  0/362 (0.00%)  1/364 (0.27%) 
Chronic obstructive pulmonary disease  1  0/362 (0.00%)  1/364 (0.27%) 
Dyspnoea  1  0/362 (0.00%)  1/364 (0.27%) 
Epistaxis  1  0/362 (0.00%)  1/364 (0.27%) 
Hydrothorax  1  0/362 (0.00%)  1/364 (0.27%) 
Pulmonary embolism  1  0/362 (0.00%)  3/364 (0.82%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  1/362 (0.28%)  0/364 (0.00%) 
Pruritus  1  1/362 (0.28%)  0/364 (0.00%) 
Decubitus ulcer  1  0/362 (0.00%)  1/364 (0.27%) 
Vascular disorders     
Artery dissection  1  1/362 (0.28%)  0/364 (0.00%) 
Hypotension  1  1/362 (0.28%)  0/364 (0.00%) 
Peripheral artery stenosis  1  1/362 (0.28%)  0/364 (0.00%) 
Thrombosis  1  1/362 (0.28%)  0/364 (0.00%) 
Venous insufficiency  1  1/362 (0.28%)  0/364 (0.00%) 
Air embolism  1  0/362 (0.00%)  1/364 (0.27%) 
Deep vein thrombosis  1  0/362 (0.00%)  2/364 (0.55%) 
Haematoma  1  0/362 (0.00%)  1/364 (0.27%) 
Hypertension  1  0/362 (0.00%)  1/364 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TachoSil® Current Practice Group
Affected / at Risk (%) Affected / at Risk (%)
Total   92/362 (25.41%)   102/364 (28.02%) 
Gastrointestinal disorders     
Constipation  1  24/362 (6.63%)  12/364 (3.30%) 
Nausea  1  19/362 (5.25%)  16/364 (4.40%) 
General disorders     
Pyrexia  1  12/362 (3.31%)  24/364 (6.59%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  20/362 (5.52%)  23/364 (6.32%) 
Nervous system disorders     
Pneumocephalus  1  21/362 (5.80%)  25/364 (6.87%) 
Vascular disorders     
Hypertension  1  18/362 (4.97%)  20/364 (5.49%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01355627     History of Changes
Other Study ID Numbers: TC-2402-038-SP
First Submitted: May 11, 2011
First Posted: May 18, 2011
Results First Submitted: June 26, 2014
Results First Posted: July 25, 2014
Last Update Posted: July 25, 2014