An open label, prospective, randomized, parallel groups, multicenter study to compare the efficacy and safety of TachoSil® versus Surgicel Original(oxidized regenerated cellulose) as an adjunct to control mild to moderate soft tissue bleeding during surgery.
Troy Markel, MD
Primary Investigator
Brief description of study
Detailed description of study
The study consists of 4 phases: Screening (assessments up to 5 days prior to surgery),
treatment period (1 day for surgery), approximately 7 days post-surgery in-house stay, and
safety follow-up (30 days ± 7 after surgery).
Surgical procedures will be performed according to standard of care, with the exception of the
use of fibrin sealants, local thrombin, and other additional local hemostatic products. During
surgery, investigators will identify the target bleeding site (TBS) with mild (Grade 1) to
moderate (Grade 2) bleeding, which was defined on the validated intraoperative bleeding
scale. The TBS should be less than the size of the one study intervention (either TachoSil or
Surgicel) (21 cm 2 /3.3 in2) to achieve hemostatic success.
Participants will be assigned randomly in a 1:1 ratio to one of the two study interventions via a
centralized allocation system, if the participants fulfill the pre- and intra-operative eligibility criteria.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Soft tissue bleeding, Riley
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Age: 2 years - 100 years
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Gender: All
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Properly completed participant informed consent/assent.
2. Male or female aged 2 years or older.
3. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant
surgery except for liver or heart transplants is included.
4. Female of childbearing potential and male participants shall agree to use medically
acceptable contraception measures while on study intervention and for 1 month following
completion of study intervention. All women of childbearing potential (WOCBP) must
have a negative serum or urine pregnancy test at Screening. A woman is considered of
childbearing potential unless either pre menarche or postmenopausal (≥ 1 year without
menses and confirmed with follicle stimulating hormone [FSH] test) or surgically
sterilized via bilateral oophorectomy, hysterectomy, bilateral tubal ligation.
Intra-operatively
5. The participant has a need for secondary hemostatic study intervention at the TBS with
mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale, since
primary hemostatic study intervention (eg, compression, suturing, clipping,
electrocoagulation) has not achieved adequate hemostasis.
6. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified
intra-operatively by the surgeon.
7. The TBS size < 21 cm 2 /3.3 in2 .
8. Ability to firmly press study intervention at TBS until 3 minutes after randomization.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
1. Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
2. Congenital or acquired disorders of coagulation (eg, platelet function disorders,
hemophilia, Von Willebrand disease, coagulation factor deficiency etc,).
3. History of hypersensitivity to active or inactive excipients of study interventions or
interventions with a similar chemical structure or class to study intervention.
4. Participants who may be at risk for hypersensitivity to blood-derived products, such as
those with a known history of immunoglobulin A deficiency.
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5. Judgment by the investigator that the participant should not participate in the study if the
participant is unlikely to comply with all study procedures and study intervention.
6. Significant medical or psychiatric illness that would interfere with compliance and ability
to tolerate study intervention as outlined in the study protocol.
7. Current participation in a clinical study with a study intervention or device or participation
within 3 months of enrollment in the study.
8. Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed
out prior to randomization. Only heparin is permitted for thromboembolic prophylaxis at
doses and durations routinely used in the center.
9. Current or suspected intervention or alcohol abuse by judgment
10. Positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus, or
human immunodeficiency virus 1 and 2.
11. Screening Hemoglobin < 9 mg/dL, platelets < 75 × 103 /μL, and/or international
normalized ratio (INR) > 1.5.
12. Drug abuse as per the investigator judgement, or positive screening test of any of the
substances in the drug screen, unless there is an existing valid prescription for the drug.
Intra-operatively
13. Acute major bleeding during surgery, defined as bleeding that requires surgery or
transfusion of > 2 units of packed red blood cells.
14. Participant with TBS in an actively infected field (Class III Contaminated or Class IV
Dirty or Infected). 9
15. Target bleeding site is from large defects in arteries or veins where the injured vascular
wall requires repair with maintenance of vessel patency, and which would result in
persistent exposure of the study intervention to blood flow and pressure during healing and
absorption of the study intervention.
16. Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
17. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
18. Participants with Grade ‘0’, ‘3’, and ‘4’ bleeding at TBS according to VIBe Scale.
