A Study of Intra-thrombus Plasmin (Human) In Acute Periph... | NCT01222117

ID	Type	Description	Link
2010-019760-36	EudraCT Number

Label	Type	Description	Intervention Names
Plasmin Open-label Treatment Group A	Experimental	Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.	Biological: Plasmin
Plasmin Open-label Treatment Group B	Experimental	Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate	Biological: Plasmin
Plasmin Open-label Treatment Group C	Experimental	Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.	Biological: Plasmin
Plasmin Open-label Treatment Group D	Experimental	Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate	Biological: Plasmin
Plasminogen Activator Blinded Group E	Active Comparator	PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice	Biological: Plasminogen Activator

Name	Type	Description	Arm Group Labels	Other Names
Plasmin	Biological	Plasmin prepared in 0.9% saline for injection	Plasmin Open-label Treatment Group A Plasmin Open-label Treatment Group B Plasmin Open-label Treatment Group C

Measure	Description	Time Frame
The Proportion of Subjects With >50% Thrombolysis	The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography.	5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)

Measure	Description	Time Frame
The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.	The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability.	30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral limb ischemia - Society of Vascular Surgery Categories I and IIa
Onset of symptoms less than or equal to 14 days
Thrombosed infrainguinal bypass graft or native artery
Diagnosis by arteriography of occlusive thrombus in graft or artery
Ability to embed the infusion catheter into the thrombus
Women of childbearing potential must use contraception and have a negative pregnancy test

Exclusion Criteria:

Any medical or social condition that may interfere with study participation
Women who are pregnant or lactating
Hemorrhagic stroke history
Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack) within one year
Intracranial or spinal neurosurgery, or severe intracranial trauma in the last 3 months
Major surgery, organ biopsy, or major trauma within the past 10 days
Lumbar puncture or non-compressible arterial puncture in the past 10 days
Intraocular surgery within the past 10 days
Active gastrointestinal or organ bleeding
Uncontrolled arterial hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
Known intracranial neoplasm, aneurysm, or arteriovenous malformation
Current bleeding diathesis
Platelet count <75 x 10e9/L
Active graft infection
Occlusion occurred within one month of synthetic graft placement
Occlusion occurred within 6 months of autologous graft placement
A sequential composite graft with dual outflows to correct multiple occlusions
Medically unable to tolerate an open vascular procedure
Known prothrombotic state
Hemoglobin <10.0 g/dL
Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine >2.0 mg/dL
Treatment with a full dose plasminogen activator (PA) within the last 48 hours
Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days
Treatment with oral anticoagulants, and with an international normalized ratio of >1.7

Name	Affiliation	Role
Kecia Courtney	Grifols Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Kaleida Health System		Buffalo	New York	14209	United States
Cleveland Clinic

PubMed Identifier	Type	Citation	Retractions
31069128	Derived	Comerota AJ, Davidovic L, Hanna K, Courtney KL, Shlansky-Goldberg RD. Phase 2, randomized, open-label study on catheter-directed thrombolysis with plasmin versus rtPA and placebo in acute peripheral arterial occlusion. J Drug Assess. 2019 Apr 9;8(1):43-54. doi: 10.1080/21556660.2019.1586402. eCollection 2019.

ID	Title	Description
FG000	Plasmin Open-label Treatment Group A	Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection
FG001	Plasmin Open-label Treatment Group B

Arm/Group Information

ID	Title	Description
BG000	Plasmin Open-label Treatment Group A	Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection
BG001	Plasmin Open-label Treatment Group B	Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
BG002	Plasmin Open-label Treatment Group C	Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection
BG003	Plasmin Open-label Treatment Group D	Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
BG004	Plasminogen Activator Blinded Group E	PA administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.
BG005	PA Placebo Blinded Treatment Arm F	PA placebo (normal saline for injection) administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration Placebo: Normal saline for injection at the same volume as the plasminogen activator.
BG006	Plasmin Open-label Treatment Group G	Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
BG007	Plasmin Open-label Treatment Group H	Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
BG008	Plasmin Open-label Treatment Group I	Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection
BG009	Plasmin Open-label Treatment Group J	Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection
BG010	Plasmin Open-label Treatment Group M	Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection
BG011	Total	Total of all reporting groups

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

Primary

The Proportion of Subjects With >50% Thrombolysis

The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography.

In groups A-D, G and H, 8 subjects were excluded (EOT arteriogram missing or not read, did not receive >=90% of dose). In groups I and J, 11 subjects were excluded (BOC not inserted/appropriately inflated, missing an arteriogram). In group F, 1 subject was not dosed and 4 subjects were excluded (did not receive >=90% of dose).

Posted

Number

percentage of participants

5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)

ID	Title	Description
OG000	Plasmin Open-label Treatment Group A	Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection
OG001	Plasmin Open-label Treatment Group B	Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
OG002	Plasmin Open-label Treatment Group C	Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection
OG003	Plasmin Open-label Treatment Group D	Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
OG004	Plasminogen Activator Blinded Group E	PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.
OG005	PA Placebo Blinded Treatment Arm F	PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration Placebo: Normal saline for injection at the same volume as the plasminogen activator.
OG006	Plasmin Open-label Treatment Group G	Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
OG007	Plasmin Open-label Treatment Group H	Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
OG008	Plasmin Open-label Treatment Group I	Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection
OG009	Plasmin Open-label Treatment Group J	Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection
OG010	Plasmin Open-label Treatment Group M	Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection

Units	Counts
Participants	OG00016 OG00119 OG00221 OG003

Title

Denominators

Categories

Title	Measurements
	OG00043.8 OG00147.4 OG00281.0 OG003

Secondary

The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.

The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability.

Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Plasmin Open-label Treatment Group A	Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection
OG001	Plasmin Open-label Treatment Group B	Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection
OG002	Plasmin Open-label Treatment Group C	Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Plasmin Open-label Treatment Group A	Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection	10	20	14	20
EG001	Plasmin Open-label Treatment Group B	Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection	4	20	11	20
EG002	Plasmin Open-label Treatment Group C	Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate. Plasmin: Plasmin prepared in 0.9% saline for injection	6	22	18	22
EG003	Plasmin Open-label Treatment Group D	Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection	4	20	14	20
EG004	Plasminogen Activator Blinded Group E	PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment.	2	9	7	9
EG005	PA Placebo Blinded Treatment Arm F	PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration Placebo: Normal saline for injection at the same volume as the plasminogen activator.	5	9	8	9
EG006	Plasmin Open-label Treatment Group G	Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection	4	13	7	13
EG007	Plasmin Open-label Treatment Group H	Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate Plasmin: Plasmin prepared in 0.9% saline for injection	3	12	5	12
EG008	Plasmin Open-label Treatment Group I	Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection	7	21	12	21
EG009	Plasmin Open-label Treatment Group J	Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection	2	17	10	17
EG010	Plasmin Open-label Treatment Group M	Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter Plasmin: Plasmin prepared in 0.9% saline for injection	0	6	3	6

Serious Adverse Events

Term	Organ System	Statistical Information
Peripheral ischaemia	Vascular disorders	EG0004 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG0032 affected20 at risk EG0040 affected9 at risk EG0053 affected9 at risk EG0060 affected13 at risk EG0072 affected12 at risk EG0080 affected21 at risk EG0090 affected17 at risk EG0100 affected6 at risk
Peripheral embolism	Vascular disorders	EG0004 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Thrombosis	Vascular disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Reocclusion	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Ischaemia	Vascular disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Vascular graft thrombosis	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Renal failure acute	Renal and urinary disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Femoral arterial stenosis	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Haematoma	Vascular disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Shock haemorrhagic	Vascular disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Anaemia postoperative	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Anastomotic haemorrhage	Injury, poisoning and procedural complications	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Graft thrombosis	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Haematuria	Renal and urinary disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Myocardial infarction	Cardiac disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Vessel puncture site reaction	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Peroneal nerve palsy	Nervous system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Multi-organ failure	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Arterial haemorrhage	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Cerebral haemorrhage	Nervous system disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Syncope	Nervous system disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Sepsis	Infections and infestations	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Catheter site haemorrhage	General disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Arterial thrombosis limb	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Ischaemic limb pain	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Reperfusion injury	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Operative haemorrhage	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Puncture site haemorrhage	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Catheter site pain	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003

Other Adverse Events

Term	Organ System	Statistical Information
Peripheral embolism	Vascular disorders	EG0004 affected20 at risk EG0012 affected20 at risk EG0026 affected22 at risk EG0031 affected20 at risk EG0041 affected9 at risk EG0051 affected9 at risk EG0062 affected13 at risk EG0070 affected12 at risk EG0084 affected21 at risk EG0093 affected17 at risk EG0100 affected6 at risk
Haematoma	Vascular disorders	EG0000 affected20 at risk EG0012 affected20 at risk EG0021 affected22 at risk EG003
Peripheral ischaemia	Vascular disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Arterial thrombosis limb	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Hypertension	Vascular disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0022 affected22 at risk EG003
Ischaemia	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Femoral artery embolism	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Hypotension	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Ischaemic limb pain	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Extremity necrosis	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Iliac artery stenosis	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Labile blood pressure	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Peripheral artery dissection	Vascular disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Infusion related reaction	General disorders	EG0005 affected20 at risk EG0012 affected20 at risk EG0025 affected22 at risk EG003
Pyrexia	General disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0023 affected22 at risk EG003
Puncture site haemorrhage	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Oedema peripheral	General disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Chest discomfort	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Infusion site haemorrhage	General disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Local swelling	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Puncture site pain	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Vessel puncture site haematoma	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Reocclusion	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Vascular graft thrombosis	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	EG0002 affected20 at risk EG0012 affected20 at risk EG0021 affected22 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0022 affected22 at risk EG003
Haematuria	Renal and urinary disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0021 affected22 at risk EG003
Renal failure acute	Renal and urinary disorders	EG0001 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Haemoglobin decreased	Investigations	EG0001 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Aspartate aminotransferase increased	Investigations	EG0000 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Blood glucose increased	Investigations	EG0000 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Haematocrit decreased	Investigations	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Anaemia	Blood and lymphatic system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Hypercoagulation	Blood and lymphatic system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Nausea	Gastrointestinal disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Vomiting	Gastrointestinal disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Disorientation	Psychiatric disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Restlessness	Psychiatric disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Presyncope	Nervous system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Paraesthesia	Nervous system disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Angina pectoris	Cardiac disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Graft infection	Infections and infestations	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Device leakage	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Alanine aminotransferase increased	Investigations	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Blood cholesterol increased	Investigations	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Red blood cell count decreased	Investigations	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Oliguria	Renal and urinary disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Complication of device removal	General disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Injection site haematoma	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Injection site haemorrhage	General disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Pain	General disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Renal failure	Renal and urinary disorders	EG0001 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Blood pressure increased	Investigations	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Hepatic enzyme increased	Investigations	EG0001 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Blood alkaline phosphatase increased	Investigations	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Blood fibrinogen decreased	Investigations	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Gamma-glutamyltransferase increased	Investigations	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Anaemia of chronic disease	Blood and lymphatic system disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Lymphocytosis	Blood and lymphatic system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Neutrophilia	Blood and lymphatic system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Constipation	Gastrointestinal disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Anxiety	Psychiatric disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Insomnia	Psychiatric disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	EG0001 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Cardiac failure	Cardiac disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Oral candidiasis	Infections and infestations	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Tachycardia	Cardiac disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Hypersensitivity	Immune system disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Post procedural infection	Infections and infestations	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Postoperatvie wound infection	Infections and infestations	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Acidosis	Metabolism and nutrition disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Dizziness	Nervous system disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Sleep disorder	Psychiatric disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Proteinuria	Renal and urinary disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Renal failure chronic	Renal and urinary disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	EG0000 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	EG0001 affected20 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Peripheral artery aneurysm	Vascular disorders	EG0000 affected20 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003

ID	Term
D005341	Fibrinolysin
D010960	Plasminogen Activators
D010959	Tissue Plasminogen Activator
D014568	Urokinase-Type Plasminogen Activator
D000077330	Saline Solution

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D057057	Serine Proteases
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001685	Biological Factors
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations