Trial Outcomes & Findings for TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM) (NCT NCT00440401)

Last Updated: 2012-05-08

Results Overview

Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

120 participants

Primary outcome timeframe

3 minutes

Results posted on

2012-05-08

Participant Flow

From the total of 120 enrolled subjects, data are presented for 119 randomised subjects that received trial treatment (= Intention to Treat (ITT) population).

Participant milestones

Participant milestones
Measure	TachoSil® Absorbable sponge for intra-operative topical application	Comparator Standard haemostatic treatment in cardiovascular surgery
Overall Study STARTED	59	60
Overall Study COMPLETED	55	54
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	TachoSil® Absorbable sponge for intra-operative topical application	Comparator Standard haemostatic treatment in cardiovascular surgery
Overall Study Adverse Event	2	1
Overall Study Other	2	5

Baseline Characteristics

TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TachoSil® n=59 Participants	Standard Treatment n=60 Participants	Total n=119 Participants Total of all reporting groups
Age, Customized 18-65 years	24 participants n=93 Participants	21 participants n=4 Participants	45 participants n=27 Participants
Age, Customized 65 years or above	35 participants n=93 Participants	39 participants n=4 Participants	74 participants n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	17 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	45 Participants n=93 Participants	43 Participants n=4 Participants	88 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	59 participants n=93 Participants	60 participants n=4 Participants	119 participants n=27 Participants
Classification of surgery	44 Percentage of subjects n=93 Participants	59 Percentage of subjects n=4 Participants	103 Percentage of subjects n=27 Participants
Evaluation of bleeding at target area before randomization Arterial	48 participants n=93 Participants	40 participants n=4 Participants	88 participants n=27 Participants
Evaluation of bleeding at target area before randomization Venous	11 participants n=93 Participants	20 participants n=4 Participants	31 participants n=27 Participants
Evaluation of bleeding at target area before randomization Mild haemorrhage	19 participants n=93 Participants	24 participants n=4 Participants	43 participants n=27 Participants
Evaluation of bleeding at target area before randomization Moderate haemorrhage	35 participants n=93 Participants	34 participants n=4 Participants	69 participants n=27 Participants
Evaluation of bleeding at target area before randomization Severe haemorrhage	5 participants n=93 Participants	2 participants n=4 Participants	7 participants n=27 Participants
Identification of target area for efficacy evaluation Aorta	35 participants n=93 Participants	32 participants n=4 Participants	67 participants n=27 Participants
Identification of target area for efficacy evaluation Coronary anastomosis	2 participants n=93 Participants	3 participants n=4 Participants	5 participants n=27 Participants
Identification of target area for efficacy evaluation Internal mammary artery vascular bed	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Identification of target area for efficacy evaluation Left atrium	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants
Identification of target area for efficacy evaluation Left ventricle	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants
Identification of target area for efficacy evaluation Right atrium	5 participants n=93 Participants	10 participants n=4 Participants	15 participants n=27 Participants
Identification of target area for efficacy evaluation Right ventricle	11 participants n=93 Participants	8 participants n=4 Participants	19 participants n=27 Participants
Identification of target area for efficacy evaluation Other	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants
Primary haemostatic treatment Suturing	43 participants n=93 Participants	43 participants n=4 Participants	86 participants n=27 Participants
Primary haemostatic treatment Electro-coagulation	6 participants n=93 Participants	5 participants n=4 Participants	11 participants n=27 Participants
Primary haemostatic treatment Clips	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants
Primary haemostatic treatment Gauze	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Primary haemostatic treatment None	10 participants n=93 Participants	12 participants n=4 Participants	22 participants n=27 Participants
Type of tissue Tissue	16 participants n=93 Participants	22 participants n=4 Participants	38 participants n=27 Participants
Type of tissue Vessel	43 participants n=93 Participants	38 participants n=4 Participants	81 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 minutes

Population: Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined "as randomised" and the Safety population (= basis for Adverse Events analyses) was defined "as treated".

Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.

Outcome measures

Outcome measures
Measure	TachoSil® n=59 Participants	Standard Treatment n=60 Participants
Proportion of Subjects Achieving Haemostasis at 3 Minutes	0.746 Proportion of Subjects Interval 0.635 to 0.857	0.333 Proportion of Subjects Interval 0.214 to 0.453

SECONDARY outcome

Timeframe: 6 minutes

Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.

Outcome measures

Outcome measures
Measure	TachoSil® n=59 Participants	Standard Treatment n=60 Participants
Proportion of Subjects Achieving Haemostasis at 6 Minutes.	0.949 Proportion of Subjects Interval 0.893 to 1.0	0.717 Proportion of Subjects Interval 0.603 to 0.831

Adverse Events

TachoSil®

Serious events: 8 serious events

Other events: 38 other events

Deaths: 0 deaths

Standard Treatment

Serious events: 18 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Responsible

Medical Scientific Strategy

Phone: +45 4677 1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	TachoSil® n=62 participants at risk	Standard Treatment n=57 participants at risk
Blood and lymphatic system disorders Haemorrhagic anaemia	8.1% 5/62 • Number of events 5 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	10.5% 6/57 • Number of events 6 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Cardiac disorders Atrial fibrillation	27.4% 17/62 • Number of events 17 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	17.5% 10/57 • Number of events 10 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Cardiac disorders Bradycardia	1.6% 1/62 • Number of events 1 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	5.3% 3/57 • Number of events 3 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Cardiac disorders Pericardial effusion	4.8% 3/62 • Number of events 3 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	7.0% 4/57 • Number of events 4 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Cardiac disorders Tachyarrhythmia	6.5% 4/62 • Number of events 4 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	7.0% 4/57 • Number of events 4 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Gastrointestinal disorders Constipation	4.8% 3/62 • Number of events 3 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	5.3% 3/57 • Number of events 3 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Gastrointestinal disorders Nausea	12.9% 8/62 • Number of events 8 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	8.8% 5/57 • Number of events 5 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
General disorders Pyrexia	6.5% 4/62 • Number of events 4 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	5.3% 3/57 • Number of events 3 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Injury, poisoning and procedural complications Post procedural haemorrhage	3.2% 2/62 • Number of events 2 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	5.3% 3/57 • Number of events 3 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Investigations Haemoglobin decreased	0.00% 0/62 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	5.3% 3/57 • Number of events 3 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Metabolism and nutrition disorders Hyperglycaemia	9.7% 6/62 • Number of events 6 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	12.3% 7/57 • Number of events 7 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Psychiatric disorders Psychotic disorder	0.00% 0/62 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	7.0% 4/57 • Number of events 4 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Respiratory, thoracic and mediastinal disorders Pleural effusion	22.6% 14/62 • Number of events 14 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	15.8% 9/57 • Number of events 9 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.5% 4/62 • Number of events 4 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	3.5% 2/57 • Number of events 3 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).
Vascular disorders Hypotension	3.2% 2/62 • Number of events 2 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).	7.0% 4/57 • Number of events 4 SAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone). Basis for analysis was the safety population (= all subjects randomised and given trial treatment).