Trial Outcomes & Findings for Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis (NCT NCT00684047)
NCT ID: NCT00684047
Last Updated: 2016-01-25
Results Overview
The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
239 participants
Primary outcome timeframe
The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.
Results posted on
2016-01-25
Participant Flow
Study Initiation Date: 20 October 2008 Study Completion Date: 05 May 2014
Participant milestones
| Measure |
FS Grifols Preliminary Part (I)
FS Grifols was applied in all subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
|
FS Grifols Primary Part (II)
FS Grifol was applied in subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
|
Manual Compression Primary Part (II)
Manual Compression was applied in subjects in this arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
72
|
110
|
57
|
|
Overall Study
COMPLETED
|
59
|
94
|
52
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
Baseline characteristics by cohort
| Measure |
FS Grifols Preliminary Part (I)
n=72 Participants
Subjects treated during FS Grifols Preliminary Part (I) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
|
FS Grifols Primary Part (II)
n=110 Participants
Subjects treated during FS Grifols Primary Part (II) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
|
Manual Compression Primary Part (II)
n=57 Participants
Subjects treated with manual compression were analyzed.
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 8.91 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 8.90 • n=7 Participants
|
67.0 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 9.23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.
Outcome measures
| Measure |
FS Grifols Primary Part (II)
n=110 Participants
FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
|
Manual Compression Primary Part (II)
n=57 Participants
Manual compression was applied during the Manual Compression Primary Part (II).
|
|---|---|---|
|
The Primary Efficacy Endpoint is Time to Hemostasis.
TTH ≤ 3 minutes (cumulative, % )
|
46.4 percentage of subjects
|
26.3 percentage of subjects
|
|
The Primary Efficacy Endpoint is Time to Hemostasis.
TTH ≤ 4 minutes (cumulative, %)
|
62.7 percentage of subjects
|
31.6 percentage of subjects
|
|
The Primary Efficacy Endpoint is Time to Hemostasis.
TTH ≤ 5 minutes (cumulative, %)
|
74.5 percentage of subjects
|
49.1 percentage of subjects
|
|
The Primary Efficacy Endpoint is Time to Hemostasis.
TTH ≤ 7 minutes (cumulative, %)
|
79.1 percentage of subjects
|
56.1 percentage of subjects
|
|
The Primary Efficacy Endpoint is Time to Hemostasis.
TTH ≤ 10 minutes (cumulative, %)
|
88.2 percentage of subjects
|
71.9 percentage of subjects
|
|
The Primary Efficacy Endpoint is Time to Hemostasis.
Treatment Failure
|
11.8 percentage of subjects
|
28.1 percentage of subjects
|
SECONDARY outcome
Timeframe: 10 minutes from the start of treatment application at the target bleeding sitePopulation: intent to treat population
The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II)
Outcome measures
| Measure |
FS Grifols Primary Part (II)
n=110 Participants
FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
|
Manual Compression Primary Part (II)
n=57 Participants
Manual compression was applied during the Manual Compression Primary Part (II).
|
|---|---|---|
|
Proportions of Subjects Achieving Hemostasis
|
88.2 percentage of participants
|
71.9 percentage of participants
|
SECONDARY outcome
Timeframe: 10 minutes from the start of treatment application at the target bleeding sitePopulation: intent to treat population
The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II)
Outcome measures
| Measure |
FS Grifols Primary Part (II)
n=110 Participants
FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
|
Manual Compression Primary Part (II)
n=57 Participants
Manual compression was applied during the Manual Compression Primary Part (II).
|
|---|---|---|
|
Prevalence of Treatment Failures
|
11.8 percentage of participants
|
28.1 percentage of participants
|
Adverse Events
FS Grifols [Pooled Preliminary Part (I) + Primary Part (II)]
Serious events: 47 serious events
Other events: 151 other events
Deaths: 0 deaths
Manual Compression Primary Part (II)
Serious events: 9 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FS Grifols [Pooled Preliminary Part (I) + Primary Part (II)]
n=187 participants at risk
The safety population included all subjects treated with FS Grifols in Preliminary Part (I) and Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols): Preliminary Part (I): 72 subjects and Primary Part (II): 110 subjects.
The safety population included five additional subjects treated with FS Grifols instead of manual compression who were not included in the baseline and efficacy outcome analyses.
|
Manual Compression Primary Part (II)
n=52 participants at risk
The safety population included all subjects treated with manual compression in the Manual Compression Primary Part (II). Five subjects randomized to this arm were treated with FS Grifols and thus were removed from this arm for the safety analyses.
|
|---|---|---|
|
Infections and infestations
Post Operative Wound Infection
|
2.1%
4/187 • Number of events 4 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Infections and infestations
Wound Infection
|
1.6%
3/187 • Number of events 3 • Six weeks
|
3.8%
2/52 • Number of events 2 • Six weeks
|
|
Infections and infestations
Abdominal Sepsis
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Infections and infestations
Pneumonia
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Infections and infestations
Respiratory Tract Infection
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Infections and infestations
Diabetic Foot Infection
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Cardiac disorders
Cardiac Arrest
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Cardiac disorders
Cardiac Failure
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Cardiac disorders
Cardio-respiratory Arrest
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Cardiac disorders
Myocardial Infarction
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Injury, poisoning and procedural complications
Graft Haemorrhage
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Nervous system disorders
Transient Ischemic Attack
|
1.1%
2/187 • Number of events 3 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Nervous system disorders
Cerebral Infarction
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Nervous system disorders
Aphasia
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Gastrointestinal disorders
Hernial Eventration
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Vascular disorders
Intra-abdominal Haemorrhage
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Vascular disorders
Hypertension
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Vascular disorders
Aortic Aneurysm
|
0.53%
1/187 • Number of events 1 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Renal and urinary disorders
Haematuria
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Renal and urinary disorders
Renal Failure
|
1.1%
2/187 • Number of events 2 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Psychiatric disorders
Confusional State
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Psychiatric disorders
Delirium
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
General disorders
Chest Discomfort
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
General disorders
Multiorgan Failure
|
0.00%
0/187 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.53%
1/187 • Number of events 1 • Six weeks
|
0.00%
0/52 • Six weeks
|
Other adverse events
| Measure |
FS Grifols [Pooled Preliminary Part (I) + Primary Part (II)]
n=187 participants at risk
The safety population included all subjects treated with FS Grifols in Preliminary Part (I) and Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols): Preliminary Part (I): 72 subjects and Primary Part (II): 110 subjects.
The safety population included five additional subjects treated with FS Grifols instead of manual compression who were not included in the baseline and efficacy outcome analyses.
|
Manual Compression Primary Part (II)
n=52 participants at risk
The safety population included all subjects treated with manual compression in the Manual Compression Primary Part (II). Five subjects randomized to this arm were treated with FS Grifols and thus were removed from this arm for the safety analyses.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural Pain
|
59.9%
112/187 • Number of events 113 • Six weeks
|
69.2%
36/52 • Number of events 36 • Six weeks
|
|
Gastrointestinal disorders
Nausea
|
23.5%
44/187 • Number of events 51 • Six weeks
|
19.2%
10/52 • Number of events 11 • Six weeks
|
|
Gastrointestinal disorders
Constipation
|
20.9%
39/187 • Number of events 39 • Six weeks
|
15.4%
8/52 • Number of events 8 • Six weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
14/187 • Number of events 25 • Six weeks
|
11.5%
6/52 • Number of events 6 • Six weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
9/187 • Number of events 11 • Six weeks
|
3.8%
2/52 • Number of events 2 • Six weeks
|
|
Infections and infestations
Urinary Tract Infection
|
7.0%
13/187 • Number of events 13 • Six weeks
|
5.8%
3/52 • Number of events 3 • Six weeks
|
|
Vascular disorders
Hypotension
|
17.1%
32/187 • Number of events 34 • Six weeks
|
15.4%
8/52 • Number of events 8 • Six weeks
|
|
Investigations
Blood Potassium Decreased
|
6.4%
12/187 • Number of events 13 • Six weeks
|
9.6%
5/52 • Number of events 5 • Six weeks
|
|
General disorders
Pyrexia
|
7.5%
14/187 • Number of events 15 • Six weeks
|
5.8%
3/52 • Number of events 3 • Six weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
11/187 • Number of events 12 • Six weeks
|
5.8%
3/52 • Number of events 3 • Six weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
8/187 • Number of events 8 • Six weeks
|
5.8%
3/52 • Number of events 4 • Six weeks
|
|
Vascular disorders
Hypertension
|
3.7%
7/187 • Number of events 7 • Six weeks
|
5.8%
3/52 • Number of events 3 • Six weeks
|
|
Vascular disorders
Haematoma
|
3.7%
7/187 • Number of events 8 • Six weeks
|
5.8%
3/52 • Number of events 4 • Six weeks
|
|
Investigations
Blood Magnesium Decreased
|
2.7%
5/187 • Number of events 5 • Six weeks
|
5.8%
3/52 • Number of events 3 • Six weeks
|
|
Nervous system disorders
Hypoaesthesia
|
1.6%
3/187 • Number of events 3 • Six weeks
|
5.8%
3/52 • Number of events 3 • Six weeks
|
|
General disorders
Oedema Peripheral
|
4.8%
9/187 • Number of events 9 • Six weeks
|
9.6%
5/52 • Number of events 5 • Six weeks
|
|
Psychiatric disorders
Insomnia
|
3.7%
7/187 • Number of events 7 • Six weeks
|
5.8%
3/52 • Number of events 3 • Six weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
16/187 • Number of events 17 • Six weeks
|
1.9%
1/52 • Number of events 1 • Six weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor at least thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsor's request, Site will remove any Confidential Information (other than Study results), and incorporate all reasonable comments by Sponsor, or delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor's Inventions.
- Publication restrictions are in place
Restriction type: OTHER