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An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Impairment |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Major Bleeding Events (MBE) | Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
| Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality | The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality. | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
| Measure | Description | Time Frame |
|---|---|---|
| Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality | Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
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Inclusion criteria:
Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study
Exclusion criteria:
All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC):
severe renal impairment (creatinine clearance < 30 ml/min); elevated liver enzymes > 2 upper limit of normal (ULN); Hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post-operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment
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Moderate renal insufficiency
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.84.4301 Boehringer Ingelheim Investigational Site | Vienna | Austria | ||||
| 1160.84.4310 Boehringer Ingelheim Investigational Site |
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There were 472 patients entered into the study, 428 were treated with moderate renal impairment. Treated patients with moderate renal impairment are presented.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study Design | All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Patients With Major Extra-surgical Site Bleedings | Percentage of Patients With Major Extra-surgical Site Bleedings | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
| Volume of Wound Drainage (Post-operative) | Volume of Wound Drainage after surgery | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
| Vienna |
| Austria |
| 1160.84.3311 Boehringer Ingelheim Investigational Site | Angers | France |
| 1160.84.3334 Boehringer Ingelheim Investigational Site | Bordeaux | France |
| 1160.84.3303 Boehringer Ingelheim Investigational Site | Caen | France |
| 1160.84.3314 Boehringer Ingelheim Investigational Site | Clermont-Ferrand | France |
| 1160.84.3320 Boehringer Ingelheim Investigational Site | Créteil | France |
| 1160.84.3307 Boehringer Ingelheim Investigational Site | Dijon Cédex | France |
| 1160.84.3310 Boehringer Ingelheim Investigational Site | Illkirch-Graffenstaden | France |
| 1160.84.3335 Boehringer Ingelheim Investigational Site | Le Havre | France |
| 1160.84.3326 Boehringer Ingelheim Investigational Site | Les Lilas | France |
| 1160.84.3312 Boehringer Ingelheim Investigational Site | Lyon | France |
| 1160.84.3305 Boehringer Ingelheim Investigational Site | Marseille | France |
| 1160.84.3323 Boehringer Ingelheim Investigational Site | Nantes Cédex 2 | France |
| 1160.84.3302 Boehringer Ingelheim Investigational Site | Paris | France |
| 1160.84.3306 Boehringer Ingelheim Investigational Site | Paris | France |
| 1160.84.3313 Boehringer Ingelheim Investigational Site | Pierre-Bénite | France |
| 1160.84.3324 Boehringer Ingelheim Investigational Site | Poitiers Cédex | France |
| 1160.84.3322 Boehringer Ingelheim Investigational Site | Saint Etienne Cédex 2 | France |
| 1160.84.3319 Boehringer Ingelheim Investigational Site | Saint-Saulve | France |
| 1160.84.3316 Boehringer Ingelheim Investigational Site | Toulouse Cédex 9 | France |
| 1160.84.3332 Boehringer Ingelheim Investigational Site | Vannes Cédex | France |
| 1160.84.04903 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1160.84.04947 Boehringer Ingelheim Investigational Site | Erlangen | Germany |
| 1160.84.4922 Boehringer Ingelheim Investigational Site | Gelnhausen | Germany |
| 1160.84.04927 Boehringer Ingelheim Investigational Site | Hachenburg | Germany |
| 1160.84.04929 Boehringer Ingelheim Investigational Site | Koblenz | Germany |
| 1160.84.04902 Boehringer Ingelheim Investigational Site | Marburg | Germany |
| 1160.84.04946 Boehringer Ingelheim Investigational Site | München | Germany |
| 1160.84.04913 Boehringer Ingelheim Investigational Site | Olsberg | Germany |
| 1160.84.04914 Boehringer Ingelheim Investigational Site | Sylt | Germany |
| 1160.84.04938 Boehringer Ingelheim Investigational Site | Wismar | Germany |
| 1160.84.04948 Boehringer Ingelheim Investigational Site | Würzburg | Germany |
| 1160.84.03908 Boehringer Ingelheim Investigational Site | Latina | Italy |
| 1160.84.03902 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1160.84.03904 Boehringer Ingelheim Investigational Site | Monza | Italy |
| 1160.84.03909 Boehringer Ingelheim Investigational Site | Udine | Italy |
| 1160.84.3409 Boehringer Ingelheim Investigational Site | Badalona (Barcelona) | Spain |
| 1160.84.3410 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1160.84.3403 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1160.84.3405 Boehringer Ingelheim Investigational Site | Málaga | Spain |
| 1160.84.3404 Boehringer Ingelheim Investigational Site | Pamplona | Spain |
| 1160.84.3412 Boehringer Ingelheim Investigational Site | Pozuelo de Alarcón - Madrid | Spain |
| 1160.84.3401 Boehringer Ingelheim Investigational Site | Valencia | Spain |
| 1160.84.3402 Boehringer Ingelheim Investigational Site | Zaragoza | Spain |
| 1160.84.4603 Boehringer Ingelheim Investigational Site | Kungälv | Sweden |
| 1160.84.4601 Boehringer Ingelheim Investigational Site | Motala | Sweden |
| 1160.84.4604 Boehringer Ingelheim Investigational Site | Sollefteå | Sweden |
| 1160.84.04405 Boehringer Ingelheim Investigational Site | Basildon | United Kingdom |
| 1160.84.04408 Boehringer Ingelheim Investigational Site | Bedford | United Kingdom |
| 1160.84.04403 Boehringer Ingelheim Investigational Site | Luton | United Kingdom |
| 1160.84.04401 Boehringer Ingelheim Investigational Site | Wigan | United Kingdom |
| 1160.84.04407 Boehringer Ingelheim Investigational Site | Yeovil | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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The Treated set with moderate renal impairment: this patient set included all patients with CrCl (Creatinine clearance) 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality | Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality | Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate. | Posted | Number | 95% Confidence Interval | percentage of participants | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
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| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients With Major Bleeding Events (MBE) | Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation | Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate. | Posted | Number | 95% Confidence Interval | percentage of participants | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality | The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality. | Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate. | Posted | Number | 95% Confidence Interval | percentage of Participants | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
|
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| Secondary | Percentage of Patients With Major Extra-surgical Site Bleedings | Percentage of Patients With Major Extra-surgical Site Bleedings | Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate. | Posted | Number | 95% Confidence Interval | percentage of Participants | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
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| Secondary | Volume of Wound Drainage (Post-operative) | Volume of Wound Drainage after surgery | Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate. | Posted | Mean | Standard Deviation | ml | From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa |
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From first drug intake up to 24 h after last drug intake; planned number of days after surgery: knee replacement: 10 days, hip replacement: 28-35 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily. | 34 | 468 | 24 | 468 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Catheter site haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
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| Arthritis infective | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Petit mal epilepsy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Scar | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Suture related complication | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Wound secretion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| All-cause mortality |
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