HemostasisPhase 2NCT02014402
Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery
A Phase 2 study testing Human thrombin and Bovine thrombin in people with Hemostasis, run by Instituto Grifols, S.A. at 20 sites in United States.
Trial summary
This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemostasis
- What is being tested?
- Human thrombin and Bovine thrombin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2013to Nov 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pre-operative (at Baseline Assessments Visit) hemoglobin (Hgb) ≥9.0 g/dL (deciliter)
- Pre-operative (at Baseline Assessments Visit) fibrinogen level ≥150 mg/dL (functional method).
- Required one of the following procedures:
- An elective (non-emergency), open (non-laparoscopic; non- endovascular) surgical procedure involving a native artery-graft end-to-side proximal anastomosis utilizing coated or uncoated polytetrafluoroethylene (PTFE) graft (IG1202-A).
- An elective (non-emergency), open (non-laparoscopic) hepatic resection (anatomic and non-anatomic resections of at least one anatomical hepatic segment or equivalent tissue volume) (IG-1202-B).
- An elective (non-emergency), open (non-laparoscopic), surgical procedure involving soft (non-parenchymous) tissue (IG1202-C).
- An elective (non-emergency), spinal surgical procedure in which the epidural venous plexus was exposed (IG1202-D).
- A target bleeding site (TBS) was identified according to the Investigator's judgment, and the TBS had mild or moderate bleeding according to the Investigator's judgment.
Who cannot join
- Required surgical procedure due to trauma (except for spinal surgery).
- Infection in the anatomic surgical area.
- History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived (human or animal) product.
- Previous known sensitivity to any Topical Thrombin (Human) Grifols component, any Bovine Thrombin JMI component, porcine collagen, and heparin or protamine (vascular surgery only) component.
- Received an organ transplant.
- Underwent another concurrent major surgical intervention beyond the liver (applied to hepatic surgery [IG1202-B] only; concurrent interventions on the pancreas, gall bladder, bile duct, or intestines were allowed).
Show all 17Show fewer
- Underwent a re-operative procedure, which was defined as a second, or successive, surgical procedure on the same anatomic location.
- Underwent other vascular procedures during the same surgical session (applied to vascular surgery [IG1202-A] only; stenting and/or endarterectomy of the same artery were allowed).
- Underwent a therapeutic surgical procedure within 30 days from screening (diagnostic procedures were allowed).
- Previously included in this trial (i.e. each subject could only be enrolled once in this study).
- TBS could not be identified according to the investigator's judgment.
- TBS had a severe bleeding according to the Investigator's judgment.
- Occurrence of major intra-operative complications that required resuscitation or deviation from the planned surgical procedure.
- Application of any topical haemostatic material on the resection surface of the liver prior to application of the study treatment (applied to hepatic surgery [IG1202-B] only).
- Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary haemostatic treatment (applied to hepatic surgery [IG1202-B] only).
- Intra-operative change in planned surgical procedure which resulted in subject no longer meeting preoperative inclusion and/or exclusion criteria.
- Application of any topical haemostatic material on the cut soft tissue surface prior to application of the study treatment (applied to soft tissue surgery [IG1202-C] only).
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
905
Baltimore, Maryland, 21201
803
Boulder, Colorado, 80303
508
Chapel Hill, North Carolina, 27599
604
Evanston, Illinois, 60208
503
Fort Worth, Texas, 76107
507
Gainesville, Florida, 32611
908
Hartford, Connecticut, 06102
900
Houston, Texas, 77024
902
Jackson, Mississippi, 39216
501, 901
Jacksonville, Florida, 32216
800
Las Vegas, Nevada, 89144
804
Lexington, Kentucky, 40509
602
Los Angeles, California, 90048
600
New York, New York, 10029
700, 801
Pasadena, California, 91105
606
Poughkeepsie, New York, 12601
605
Salt Lake City, Utah, 84132
802
Spokane, Washington, 99208
805
Tucson, Arizona, 85712
601
Washington D.C., District of Columbia, 20007
About this study
Official title: A Prospective, Randomized, Double-blind, Phase II Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgeries
This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.
Read the detailed description
This was a prospective, randomized, double-blind, controlled, Phase II study to evaluate the safety and efficacy of Topical Thrombin (Human) Grifols as an adjunct to hemostasis during vascular (IG1202-A), hepatic (IG1202-B), soft tissue (IG1202-C), and spinal (IG1202-D) surgical procedures. Approximately 180 subjects were randomized into 1 of 2 treatment groups in a 2:1 ratio: Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI (60 subjects) among the 4 types of surgeries. Randomized subjects were evaluated for identification of a target bleeding site (TBS) in which control of bleeding by conventional surgical techniques (including suture, ligature and cautery) was ineffective or impractical and required an adjunct treatment to achieve hemostasis. The Investigator rated the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin JMI was applied to the TBS and the time to hemostasis was assessed at various timepoints during a 5-minute observation period.
Subjects were evaluated by surgery type and by integrated analysis of clinical studies IG1202-A, IG1202-B, IG1202-C, and IG1202-D.
- Conditions
- Hemostasis
- Being tested
- Human thrombin, Bovine thrombin
- Keywords
- Vascular surgery, Hepatic surgery, Soft tissue surgery, Spinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human thrombinBiological
Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Bovine thrombinBiological
Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
| Study group | Role | What they receive |
|---|---|---|
| IG1202-A (Vascular) | Experimental | Not described Receives: Biological: Human thrombin; Biological: Bovine thrombin |
| IG1202-B (Hepatic) | Experimental | Not described Receives: Biological: Human thrombin; Biological: Bovine thrombin |
| IG1202-C (Soft Tissue) | Experimental | Not described Receives: Biological: Human thrombin; Biological: Bovine thrombin |
| IG1202-D (Spinal) | Experimental | Not described Receives: Biological: Human thrombin; Biological: Bovine thrombin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS
Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure
Measured: From start of treatment until 5 minutes after treatment start
Secondary outcomes (2)
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Cumulative proportion of subjects having achieved hemostasis by each of the following time points:
- At 3 minutes following start of study treatment
- At 4 minutes following start of study treatment
Measured: From start of treatment until 4 minutes after treatment start
Prevalence of Treatment Failures
Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments or maneuvers at the target bleeding site after the start of treatment
Measured: From start of treatment up to surgical closure by layers of the exposed surgical field containing the TBS, a median of 34 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014402
- Sponsor's protocol ID
- IG1202 (IG1202-A, -B, -C, -D)
- Status last verified
- May 2017
- First submitted
- 12 Dec 2013
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Minkowitz H, Navarro-Puerto J, Lakshman S, Singla S, Cousar C, Kim R, Villavicencio A, Kirksey L, Ayguasanosa J; Clinical Investigation Study Group on Topical Thrombin (Human) Grifols in Surgery. Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery. J Am Coll Surg. 2019 Nov;229(5):497-507.e1. doi: 10.1016/j.jamcollsurg.2019.07.008. Epub 2019 Jul 31.
PubMed 31376435
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Phase II Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgeries
- ClinicalTrials.gov ID
- NCT02014402
- Acronym / sponsor ID
- IG1202 (IG1202-A, -B, -C, -D)
- Conditions
- Hemostasis
- Keywords
- Vascular surgery, Hepatic surgery, Soft tissue surgery, Spinal surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.
Detailed description
This was a prospective, randomized, double-blind, controlled, Phase II study to evaluate the safety and efficacy of Topical Thrombin (Human) Grifols as an adjunct to hemostasis during vascular (IG1202-A), hepatic (IG1202-B), soft tissue (IG1202-C), and spinal (IG1202-D) surgical procedures. Approximately 180 subjects were randomized into 1 of 2 treatment groups in a 2:1 ratio: Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI (60 subjects) among the 4 types of surgeries. Randomized subjects were evaluated for identification of a target bleeding site (TBS) in which control of bleeding by conventional surgical techniques (including suture, ligature and cautery) was ineffective or impractical and required an adjunct treatment to achieve hemostasis. The Investigator rated the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin JMI was applied to the TBS and the time to hemostasis was assessed at various timepoints during a 5-minute observation period.
Subjects were evaluated by surgery type and by integrated analysis of clinical studies IG1202-A, IG1202-B, IG1202-C, and IG1202-D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IG1202-A (Vascular) | Experimental | Biological: Human thrombin, Biological: Bovine thrombin |
| IG1202-B (Hepatic) | Experimental | Biological: Human thrombin, Biological: Bovine thrombin |
| IG1202-C (Soft Tissue) | Experimental | Biological: Human thrombin, Biological: Bovine thrombin |
| IG1202-D (Spinal) | Experimental | Biological: Human thrombin, Biological: Bovine thrombin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Pre-operative (at Baseline Assessments Visit) hemoglobin (Hgb) ≥9.0 g/dL (deciliter)
- Pre-operative (at Baseline Assessments Visit) fibrinogen level ≥150 mg/dL (functional method).
- Required one of the following procedures:
- A target bleeding site (TBS) was identified according to the Investigator's judgment, and the TBS had mild or moderate bleeding according to the Investigator's judgment.
Key exclusion criteria (17 listed)
- Required surgical procedure due to trauma (except for spinal surgery).
- Infection in the anatomic surgical area.
- History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived (human or animal) product.
- Previous known sensitivity to any Topical Thrombin (Human) Grifols component, any Bovine Thrombin JMI component, porcine collagen, and heparin or protamine (vascular surgery only) component.
- Received an organ transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human thrombinThrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges | Biological | IG1202-A (Vascular), IG1202-B (Hepatic), IG1202-C (Soft Tissue), IG1202-D (Spinal) |
| Bovine thrombinThrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges | Biological | IG1202-A (Vascular), IG1202-B (Hepatic), IG1202-C (Soft Tissue), IG1202-D (Spinal) |
Primary outcome
Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS
Time frame: From start of treatment until 5 minutes after treatment start
Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure
2 secondary outcomes
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Time frame: From start of treatment until 4 minutes after treatment start
Prevalence of Treatment Failures
Time frame: From start of treatment up to surgical closure by layers of the exposed surgical field containing the TBS, a median of 34 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31376435Minkowitz H, Navarro-Puerto J, Lakshman S, Singla S, Cousar C, Kim R, Villavicencio A, Kirksey L, Ayguasanosa J; Clinical Investigation Study Group on Topical Thrombin (Human) Grifols in Surgery. Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery. J Am Coll Surg. 2019 Nov;229(5):497-507.e1. doi: 10.1016/j.jamcollsurg.2019.07.008. Epub 2019 Jul 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human thrombin and Bovine thrombin in people with Hemostasis, run by Instituto Grifols, S.A. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS (time frame: From start of treatment until 5 minutes after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02014402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.