Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection

• Sponsor: Baxter Healthcare Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01244425
• Collaborator: Baxter Innovations GmbH (Industry)
• Enrollment: 70
• Locations: 7
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 10
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.

Condition or Disease	Intervention/Treatment	Phase
Bleeding (Oozing) in Hepatic Resection	Drug: Fibrin Sealant (FS) VH S/D 500 s-apr; Other: Manual compression	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D 500 S-apr (Tisseel) for Hemostasis in Subjects Undergoing Hepatic Resection
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FS VH S/D 500 s-apr Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.	Drug: Fibrin Sealant (FS) VH S/D 500 s-apr; Dosage form: spray application; dosage frequency: single application; Other Names: Tisseel
Active Comparator: Manual compression - Control A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.	Other: Manual compression; Dosage form: surgical gauze swab; dosage frequency: single application

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application [4 minutes post start of treatment application]

   Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression. The following were regarded as treatment failures: No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the "time to hemostasis" was used; a time window of +5 seconds was acceptable for showing a success) Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required Reapplication of FS VH S/D 500 s-apr after 4 minutes Intraoperative rebleeding after the first 4 minutes of the observation period

Secondary Outcome Measures

1. Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment [6 minutes after start of treatment application]

   Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.

2. Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment [8 minutes after start of treatment application]

   Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.

3. Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment [10 minutes after start of treatment application]

   Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.

4. Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis [Intraoperative day 0]

   Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.

5. Percentage of Participants With Postoperative Rebleeding [Postoperative until discharged from surgical ward]

   Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration

6. Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward [Intra- and postoperative until discharged from surgical ward]

   Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.

7. Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery [Within 48 hours after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Pre-Operative Inclusion Criteria:

• Signed informed consent obtained from the subject before any study-related activities

• Subject's age is 18 years or above

• Subject will undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy

• Subject is willing and able to comply with the requirements of the protocol

• Female subjects of childbearing potential must present with a negative serum or urine pregnancy test within 72 hours before the elective liver resection

• Female subjects of childbearing potential must agree to employ adequate birth control measures for the time of their participation in the study

Intra-Operative Inclusion Criteria (before randomization):

• Resection of at least 1 anatomical segment of the liver has been performed

• Oozing from the cut surface of the liver persists after conventional resection procedure and primary control of arterial and venous bleeding by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation

• Need for additional supportive hemostatic treatment to stop bleeding (i.e. diffuse oozing) of the liver resection area

Pre-Operative Exclusion Criteria:

• Subject needs emergency liver surgery

• Subject will undergo liver resection via laparoscopic procedure

• Subject has known congenital coagulation disorder (e.g. hemophilia)

• Subject has known hypersensitivity to any ingredient of the investigational medicinal product

• Suspected inability or unwillingness of the subject to comply with trial procedures

• If female, subject is pregnant or lactating at the time of study enrollment

• Subject has already participated in this study (each subject can only be enrolled once)

• Subject has participated in another clinical study involving an investigational product or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study

Intra-operative Exclusion Criteria (before randomization):

• Occurrence of any severe surgical complication that require resuscitation or deviation from the planned surgical procedure

• Disseminated intravascular coagulopathy (DIC)

• Application of any topical hemostatic material on the resection surface of the liver prior to application of the study treatment

• Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary hemostatic treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Berlin		Germany
2		Essen		Germany
3		Hannover		Germany
4		Heidelberg		Germany
5		Jena		Germany
6		Leipzig		Germany
7		Tübingen		Germany

Sponsors and Collaborators

• Baxter Healthcare Corporation
• Baxter Innovations GmbH

Investigators

• Study Director: Baxter BioScience Medical Director, MD, Baxter Healthcare Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baxter Healthcare Corporation
• ClinicalTrials.gov Identifier: NCT01244425
• Other Study ID Numbers: 550904; 2010-018480-42
• First Posted: Nov 19, 2010
• Last Update Posted: Feb 20, 2013
• Last Verified: Feb 1, 2013

• Additional relevant MeSH terms: Fibrin Tissue Adhesive

Study Results

Participant Flow

Recruitment Details	95 participants were enrolled and screened. 23 were screen failures. 2 participants were discontinued due to: 1 was operated on by a surgeon other than the investigator, and the other underwent a prolonged operation- meaning that the investigational product (IP) could not be used. Therefore, 70 of the 95 enrolled were randomized.

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
Period Title: Overall Study
STARTED	35	35
COMPLETED	32	32
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control	Total
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.	Total of all reporting groups
Overall Participants	35	35	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.7 (14.5)	59.8 (12.8)	57.3 (13.9)
Sex: Female, Male (Count of Participants)
Female	15 42.9%	16 45.7%	31 44.3%
Male	20 57.1%	19 54.3%	39 55.7%
Region of Enrollment (participants) [Number]
Germany	35 100%	35 100%	70 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application
Description	Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression. The following were regarded as treatment failures: No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the "time to hemostasis" was used; a time window of +5 seconds was acceptable for showing a success) Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required Reapplication of FS VH S/D 500 s-apr after 4 minutes Intraoperative rebleeding after the first 4 minutes of the observation period
Time Frame	4 minutes post start of treatment application

Outcome Measure Data

Analysis Population Description

full analysis (data) set (FAS)

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4 minutes after application of the study treatment.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 4 minutes after application of the study treatment.
Measure Participants	35	35
Number (95% Confidence Interval) [percentage of participants]	82.9 236.9%	37.1 106%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FS VH S/D 500 S-apr, Manual Compression - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	likelihood-ratio chi square test
	Comments

2. Secondary Outcome

Title	Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment
Description	Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
Time Frame	6 minutes after start of treatment application

Outcome Measure Data

Analysis Population Description

Full analysis (data) set

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 6 minutes after application of the study treatment.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 6 minutes after application of the study treatment.
Measure Participants	35	35
Number (95% Confidence Interval) [percentage of participants]	91.4 261.1%	57.1 163.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FS VH S/D 500 S-apr, Manual Compression - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	likelihood ratio chi-square test
	Comments

3. Secondary Outcome

Title	Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment
Description	Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
Time Frame	8 minutes after start of treatment application

Outcome Measure Data

Analysis Population Description

Full analysis (data) set

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 8 minutes after application of the study treatment.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 8 minutes after application of the study treatment.
Measure Participants	35	35
Number (95% Confidence Interval) [percentage of participants]	91.4 261.1%	71.4 204%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FS VH S/D 500 S-apr, Manual Compression - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	likelihood ratio chi-square test
	Comments

4. Secondary Outcome

Title	Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment
Description	Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
Time Frame	10 minutes after start of treatment application

Outcome Measure Data

Analysis Population Description

Full analysis (data) set

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 10 minutes after application of the study treatment.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 10 minutes after application of the study treatment.
Measure Participants	35	35
Number (95% Confidence Interval) [percentage of participants]	94.3 269.4%	74.3 212.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FS VH S/D 500 S-apr, Manual Compression - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	likelihood ratio chi-square test
	Comments

5. Secondary Outcome

Title	Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis
Description	Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.
Time Frame	Intraoperative day 0

Outcome Measure Data

Analysis Population Description

Full analysis (data) set

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
Measure Participants	35	35
Number (95% Confidence Interval) [percentage of participants]	2.9 8.3%	8.6 24.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FS VH S/D 500 S-apr, Manual Compression - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.293
	Comments
	Method	likelihood ratio chi-square test
	Comments

6. Secondary Outcome

Title	Percentage of Participants With Postoperative Rebleeding
Description	Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration
Time Frame	Postoperative until discharged from surgical ward

Outcome Measure Data

Analysis Population Description

Full analysis (data) set

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
Measure Participants	35	35
Number (95% Confidence Interval) [Percentage of participants]	2.9 8.3%	0.0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FS VH S/D 500 S-apr, Manual Compression - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.237
	Comments
	Method	likelihood ratio chi-square test
	Comments

7. Secondary Outcome

Title	Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward
Description	Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.
Time Frame	Intra- and postoperative until discharged from surgical ward

Outcome Measure Data

Analysis Population Description

Full analysis (data) set

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
Measure Participants	35	35
Number (95% Confidence Interval) [percentage of participants]	40.0 114.3%	42.9 122.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FS VH S/D 500 S-apr, Manual Compression - Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.808
	Comments
	Method	likelihood ratio chi-square test
	Comments

8. Secondary Outcome

Title	Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery
Time Frame	Within 48 hours after surgery

Outcome Measure Data

Analysis Population Description

Full analysis (data) set Participants who received a drain and for whom the volume for the first 48 hours after surgery is available

Arm/Group Title	FS VH S/D 500 S-apr	Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
Measure Participants	32	31
Median (Full Range) [mL]	415.0	410.0

Adverse Events

Time Frame	Throughout study period (9 months)
Arm/Group Title	FS VH S/D 500 S-apr		Manual Compression - Control
Arm/Group Description	Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.		A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
All Cause Mortality
	FS VH S/D 500 S-apr		Manual Compression - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	FS VH S/D 500 S-apr		Manual Compression - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/35 (25.7%)		11/35 (31.4%)
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION	1/35 (2.9%)	1	0/35 (0%)	0
Gastrointestinal disorders
ASCITES	0/35 (0%)	0	2/35 (5.7%)	2
FAECALOMA	0/35 (0%)	0	1/35 (2.9%)	1
RETROPERITONEAL HAEMORRHAGE	0/35 (0%)	0	1/35 (2.9%)	1
General disorders
MULTI-ORGAN FAILURE	1/35 (2.9%)	1	1/35 (2.9%)	1
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS	1/35 (2.9%)	1	0/35 (0%)	0
Infections and infestations
LIVER ABSCESS	1/35 (2.9%)	1	1/35 (2.9%)	1
POSTOPERATIVE ABSCESS	0/35 (0%)	0	3/35 (8.6%)	3
SEPSIS	0/35 (0%)	0	1/35 (2.9%)	1
SEPTIC SHOCK	0/35 (0%)	0	1/35 (2.9%)	1
SUBDIAPHRAGMATIC ABSCESS	1/35 (2.9%)	1	0/35 (0%)	0
UROSEPSIS	1/35 (2.9%)	1	0/35 (0%)	0
Injury, poisoning and procedural complications
ABDOMINAL WOUND DEHISCENCE	1/35 (2.9%)	1	0/35 (0%)	0
HEPATIC HAEMATOMA	0/35 (0%)	0	2/35 (5.7%)	2
INCISIONAL HERNIA	1/35 (2.9%)	1	0/35 (0%)	0
POST PROCEDURAL BILE LEAK	4/35 (11.4%)	4	3/35 (8.6%)	3
POST PROCEDURAL HAEMORRHAGE	1/35 (2.9%)	1	0/35 (0%)	0
SMALL-FOR-SIZE LIVER SYNDROME	1/35 (2.9%)	1	0/35 (0%)	0
SPLENIC RUPTURE	1/35 (2.9%)	1	0/35 (0%)	0
Respiratory, thoracic and mediastinal disorders
ASPIRATION	1/35 (2.9%)	1	0/35 (0%)	0
PULMONARY EMBOLISM	0/35 (0%)	0	1/35 (2.9%)	1
Other (Not Including Serious) Adverse Events
	FS VH S/D 500 S-apr		Manual Compression - Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/35 (62.9%)		23/35 (65.7%)
Gastrointestinal disorders
ASCITES	1/35 (2.9%)	1	4/35 (11.4%)	4
General disorders
IMPAIRED HEALING	1/35 (2.9%)	1	3/35 (8.6%)	3
OEDEMA PERIPHERAL	1/35 (2.9%)	1	3/35 (8.6%)	3
PYREXIA	0/35 (0%)	0	2/35 (5.7%)	2
Infections and infestations
INFECTION	2/35 (5.7%)	2	4/35 (11.4%)	4
URINARY TRACT INFECTION	2/35 (5.7%)	2	0/35 (0%)	0
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE	2/35 (5.7%)	2	0/35 (0%)	0
CHEMICAL PERITONITIS	2/35 (5.7%)	2	0/35 (0%)	0
OPERATIVE HAEMORRHAGE	1/35 (2.9%)	1	3/35 (8.6%)	3
PNEUMOTHORAX TRAUMATIC	2/35 (5.7%)	2	1/35 (2.9%)	1
POST PROCEDURAL HAEMATOMA	4/35 (11.4%)	4	2/35 (5.7%)	2
Metabolism and nutrition disorders
HYPOALBUMINAEMIA	5/35 (14.3%)	5	2/35 (5.7%)	2
HYPOKALAEMIA	1/35 (2.9%)	1	5/35 (14.3%)	5
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION	7/35 (20%)	9	9/35 (25.7%)	14
Skin and subcutaneous tissue disorders
PRURITUS	2/35 (5.7%)	2	0/35 (0%)	0
Vascular disorders
HYPERTENSION	2/35 (5.7%)	3	2/35 (5.7%)	2
HYPOTENSION	2/35 (5.7%)	2	1/35 (2.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Baxter's agreements with PIs may vary per requirements of the individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥90 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (e.g., for intellectual property protection)