Peripheral Vascular DiseasesPhase 4COBBANANCT00837954
Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
A Phase 4 study testing Lyostypt® AND Surgicel®, Lyostypt® and Surgicel® in people with Peripheral Vascular Diseases and Hemostasis, run by Aesculap AG at 1 site in Germany.
Trial summary
The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel® Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Hemostasis
- What is being tested?
- Lyostypt® AND Surgicel®, Lyostypt® and Surgicel®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (PVD) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction.
- suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis
- Written informed consent
Who cannot join
- Emergency surgery
- Patients with coagulopathy or uremia
- Reoperation within one month at the same location
- Pregnant and Breastfeeding Women
- Known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin)
- Severe comorbidity (ASA ≥ 4)
Show all 12Show fewer
- Life expectancy less than 12 months
- Current immunosuppressive therapy (more than 40 mg of corticoid per day or ezathioprin)
- Chemotherapy within last 4 weeks
- Radiotherapy on the treated region within the last 2 months
- Severe psychiatric or neurologic diseases
- Lack of compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Prospective Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®
Read the detailed description
Hemostasis in peripheral vascular surgery is made more difficult by the need for direct arterial and arterial graft suturing as well as by systemic anticoagulation to prevent thrombosis during periods of vascular occlusion. Polytetrafluorethylene (PTFE) is one of the most frequently used graft materials for vascular replacement or bypass in the case when no autologous venae are available (1). However, the insufficient elasticity of PTFE and its porosity promote the development of suture hole bleeding (2,3) which can cause considerable loss of blood and prolongation of operations (2).
This study is designed to demonstrate the superiority of Lyostypt® to oxidized cellulose (Surgicel®) for hemostasis of suture hole bleeding in arterial bypass anastomoses after vascular reconstruction. Lyostypt® is an absorbable, wet stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. Therefore collagen is very effective in hemostasis. Collagen is cell-friendly whereas other hemostats significantly disturb cell growth. Advantages of collagen fleece are fast induction of hemostasis, low tissue reaction and fast absorption (15). Furthermore, collagen was shown to be the best overall hemostatic agent in microvascular surgery. Authors concluded that collagen fleece establish faster hemostasis than oxidized cellulose and that it was resorbed faster than oxidized cellulose (15).
- Conditions
- Peripheral Vascular Diseases, Hemostasis
- Being tested
- Lyostypt® AND Surgicel®, Lyostypt®, Surgicel®
- Keywords
- PTFE Graft, Suture Hole Bleeding, Hemostasis
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyostypt® AND Surgicel®Device
Also called Lyostypt®, Surgicel®
The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.
Lyostypt®Device
The investigational product is the hemostat Lyostypt®. Lyostypt® will be provided in the size 5cm x 8cm. The devices will be cut into half.
Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.
Surgicel®Procedure or surgery
The investigational product is the hemostat Surgicel® (=Tabotamp® ). Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.
Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | distal Anastomosis Lyostypt®, proximal Anastomosis Surgicel® Receives: Device: Lyostypt® AND Surgicel® |
| 2 | Active comparator | distal Anastomosis Surgicel®, proximal Anastomosis Lyostypt® Receives: Device: Lyostypt® AND Surgicel® |
| 3 | Active comparator | distal and proximal Anastomosis Lyostypt® Receives: Device: Lyostypt® |
| 4 | Active comparator | distal and proximal Anastomosis Surgicel® Receives: Procedure: Surgicel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemostasis
Measured: Minutes
Secondary outcomes (3)
Number of Complications
Measured: 30 days after surgery
Postoperative Mortality
Measured: 30 days after surgery
Efficacy Rating of Study Device evaluated by Surgeon
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hardy Schumacher, Prof. Dr., Study chair, Klinikum Hanau GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837954
- Sponsor's protocol ID
- AAG-G-H-0803
- Acronym
- COBBANA
- Status last verified
- May 2015
- First submitted
- 5 Feb 2009
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellon JM, Bujan J, Contreras LA, Hernando A, Jurado F. Similarity in behavior of polytetrafluoroethylene (ePTFE) prostheses implanted into different interfaces. J Biomed Mater Res. 1996 May;31(1):1-9. doi: 10.1002/(SICI)1097-4636(199605)31:13.0.CO;2-S.
PubMed 8731143Carney WI Jr, Lilly MP. Intraoperative evaluation of PTFE, Dacron and autogenous vein as carotid patch materials. Ann Vasc Surg. 1987 Dec;1(5):583-6. doi: 10.1016/S0890-5096(06)61445-3.
PubMed 2974302Zdrahala RJ. Small caliber vascular grafts. Part I: state of the art. J Biomater Appl. 1996 Apr;10(4):309-29. doi: 10.1177/088532829601000402.
PubMed 8859403Lumsden AB, Heyman ER; Closure Medical Surgical Sealant Study Group. Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions. J Vasc Surg. 2006 Nov;44(5):1002-1009; discussion 1009. doi: 10.1016/j.jvs.2006.06.039. Epub 2006 Oct 3.
PubMed 17020801Miller CM, Sangiolo P, Jacobson JH 2nd. Reduced anastomotic bleeding using new sutures with a needle-suture diameter ratio of one. Surgery. 1987 Feb;101(2):156-60.
PubMed 3810486Citrin P, Doscher W, Wise L, Margolis IB. Control of needle hole bleeding with ethyl-cyanoacrylate glue (Krazy Glue). J Vasc Surg. 1985 May;2(3):488-90. doi: 10.1067/mva.1985.avs0020488.
PubMed 3999241Hait MR, Robb CA, Baxter CR, Borgmann AR, Tippett LO. Comparative evaluation of Avitene microcrystalline collagen hemostat in experimental animal wounds. Am J Surg. 1973 Mar;125(3):284-7. doi: 10.1016/0002-9610(73)90042-1. No abstract available.
PubMed 4570330Hatsuoka M, Seiki M, Sasaki K, Kashii A. Hemostatic effects of microfibrillar collagen hemostat (MCH) in experimental coagulopathy model and its mechanism of hemostasis. Thromb Res. 1986 May 1;42(3):407-12. doi: 10.1016/0049-3848(86)90269-0. No abstract available.
PubMed 3520941Silverstein ME, Keown K, Owen JA, Chvapil M. Collagen fibers as a fleece hemostatic agent. J Trauma. 1980 Aug;20(8):688-94. doi: 10.1097/00005373-198008000-00010.
PubMed 7401211Czerny M, Verrel F, Weber H, Muller N, Kircheis L, Lang W, Steckmeier B, Trubel W. Collagen patch coated with fibrin glue components. Treatment of suture hole bleedings in vascular reconstruction. J Cardiovasc Surg (Torino). 2000 Aug;41(4):553-7.
PubMed 11052282Joseph T, Adeosun A, Paes T, Bahal V. Randomised controlled trial to evaluate the efficacy of TachoComb H patches in controlling PTFE suture-hole bleeding. Eur J Vasc Endovasc Surg. 2004 May;27(5):549-52. doi: 10.1016/j.ejvs.2004.01.018.
PubMed 15079782Jackson MR, Gillespie DL, Longenecker EG, Goff JM, Fiala LA, O'Donnell SD, Gomperts ED, Navalta LA, Hestlow T, Alving BM. Hemostatic efficacy of fibrin sealant (human) on expanded poly-tetrafluoroethylene carotid patch angioplasty: a randomized clinical trial. J Vasc Surg. 1999 Sep;30(3):461-6. doi: 10.1016/s0741-5214(99)70073-x.
PubMed 10477639Taylor LM Jr, Mueller-Velten G, Koslow A, Hunter G, Naslund T, Kline R; Beriplast B Investigators. Prospective randomized multicenter trial of fibrin sealant versus thrombin-soaked gelatin sponge for suture- or needle-hole bleeding from polytetrafluoroethylene femoral artery grafts. J Vasc Surg. 2003 Oct;38(4):766-71. doi: 10.1016/s0741-5214(03)00474-9.
PubMed 14560228Glickman M, Gheissari A, Money S, Martin J, Ballard JL; CoSeal Multicenter Vascular Surgery Study Group. A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin: results of a randomized controlled trial. Arch Surg. 2002 Mar;137(3):326-31; discussion 332. doi: 10.1001/archsurg.137.3.326.
PubMed 11888460Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A. The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S89-96. doi: 10.1007/s00586-004-0727-z. Epub 2004 Jun 22.
PubMed 15221572
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Prospective Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
- ClinicalTrials.gov ID
- NCT00837954
- Acronym / sponsor ID
- COBBANA / AAG-G-H-0803
- Conditions
- Peripheral Vascular Diseases, Hemostasis
- Keywords
- PTFE Graft, Suture Hole Bleeding, Hemostasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®
Detailed description
Hemostasis in peripheral vascular surgery is made more difficult by the need for direct arterial and arterial graft suturing as well as by systemic anticoagulation to prevent thrombosis during periods of vascular occlusion. Polytetrafluorethylene (PTFE) is one of the most frequently used graft materials for vascular replacement or bypass in the case when no autologous venae are available (1). However, the insufficient elasticity of PTFE and its porosity promote the development of suture hole bleeding (2,3) which can cause considerable loss of blood and prolongation of operations (2).
This study is designed to demonstrate the superiority of Lyostypt® to oxidized cellulose (Surgicel®) for hemostasis of suture hole bleeding in arterial bypass anastomoses after vascular reconstruction. Lyostypt® is an absorbable, wet stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. Therefore collagen is very effective in hemostasis. Collagen is cell-friendly whereas other hemostats significantly disturb cell growth. Advantages of collagen fleece are fast induction of hemostasis, low tissue reaction and fast absorption (15). Furthermore, collagen was shown to be the best overall hemostatic agent in microvascular surgery. Authors concluded that collagen fleece establish faster hemostasis than oxidized cellulose and that it was resorbed faster than oxidized cellulose (15).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Lyostypt® AND Surgicel®distal Anastomosis Lyostypt®, proximal Anastomosis Surgicel® |
| 2 | Active comparator | Device: Lyostypt® AND Surgicel®distal Anastomosis Surgicel®, proximal Anastomosis Lyostypt® |
| 3 | Active comparator | Device: Lyostypt®distal and proximal Anastomosis Lyostypt® |
| 4 | Active comparator | Procedure: Surgicel®distal and proximal Anastomosis Surgicel® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (PVD) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction.
- suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis
- Written informed consent
Key exclusion criteria (12 listed)
- Emergency surgery
- Patients with coagulopathy or uremia
- Reoperation within one month at the same location
- Pregnant and Breastfeeding Women
- Known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin)
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 |
|---|---|---|
| Lyostypt® AND Surgicel®Also: Lyostypt®, Surgicel®The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half. Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage. | Device | 1, 2 |
| Lyostypt®The investigational product is the hemostat Lyostypt®. Lyostypt® will be provided in the size 5cm x 8cm. The devices will be cut into half. Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. | Device | 3 |
| Surgicel®The investigational product is the hemostat Surgicel® (=Tabotamp® ). Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half. Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage. | Procedure or surgery | 4 |
Primary outcome
Time to hemostasis
Time frame: Minutes
3 secondary outcomes
Number of Complications
Time frame: 30 days after surgery
Postoperative Mortality
Time frame: 30 days after surgery
Efficacy Rating of Study Device evaluated by Surgeon
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 8731143Bellon JM, Bujan J, Contreras LA, Hernando A, Jurado F. Similarity in behavior of polytetrafluoroethylene (ePTFE) prostheses implanted into different interfaces. J Biomed Mater Res. 1996 May;31(1):1-9. doi: 10.1002/(SICI)1097-4636(199605)31:13.0.CO;2-S.
- Background: PubMed 2974302Carney WI Jr, Lilly MP. Intraoperative evaluation of PTFE, Dacron and autogenous vein as carotid patch materials. Ann Vasc Surg. 1987 Dec;1(5):583-6. doi: 10.1016/S0890-5096(06)61445-3.
- Background: PubMed 8859403Zdrahala RJ. Small caliber vascular grafts. Part I: state of the art. J Biomater Appl. 1996 Apr;10(4):309-29. doi: 10.1177/088532829601000402.
- Background: PubMed 17020801Lumsden AB, Heyman ER; Closure Medical Surgical Sealant Study Group. Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions. J Vasc Surg. 2006 Nov;44(5):1002-1009; discussion 1009. doi: 10.1016/j.jvs.2006.06.039. Epub 2006 Oct 3.
- Background: PubMed 3810486Miller CM, Sangiolo P, Jacobson JH 2nd. Reduced anastomotic bleeding using new sutures with a needle-suture diameter ratio of one. Surgery. 1987 Feb;101(2):156-60.
- Background: PubMed 3999241Citrin P, Doscher W, Wise L, Margolis IB. Control of needle hole bleeding with ethyl-cyanoacrylate glue (Krazy Glue). J Vasc Surg. 1985 May;2(3):488-90. doi: 10.1067/mva.1985.avs0020488.
- Background: PubMed 4570330Hait MR, Robb CA, Baxter CR, Borgmann AR, Tippett LO. Comparative evaluation of Avitene microcrystalline collagen hemostat in experimental animal wounds. Am J Surg. 1973 Mar;125(3):284-7. doi: 10.1016/0002-9610(73)90042-1. No abstract available.
- Background: PubMed 3520941Hatsuoka M, Seiki M, Sasaki K, Kashii A. Hemostatic effects of microfibrillar collagen hemostat (MCH) in experimental coagulopathy model and its mechanism of hemostasis. Thromb Res. 1986 May 1;42(3):407-12. doi: 10.1016/0049-3848(86)90269-0. No abstract available.
- Background: PubMed 7401211Silverstein ME, Keown K, Owen JA, Chvapil M. Collagen fibers as a fleece hemostatic agent. J Trauma. 1980 Aug;20(8):688-94. doi: 10.1097/00005373-198008000-00010.
- Background: PubMed 11052282Czerny M, Verrel F, Weber H, Muller N, Kircheis L, Lang W, Steckmeier B, Trubel W. Collagen patch coated with fibrin glue components. Treatment of suture hole bleedings in vascular reconstruction. J Cardiovasc Surg (Torino). 2000 Aug;41(4):553-7.
- Background: PubMed 15079782Joseph T, Adeosun A, Paes T, Bahal V. Randomised controlled trial to evaluate the efficacy of TachoComb H patches in controlling PTFE suture-hole bleeding. Eur J Vasc Endovasc Surg. 2004 May;27(5):549-52. doi: 10.1016/j.ejvs.2004.01.018.
- Background: PubMed 10477639Jackson MR, Gillespie DL, Longenecker EG, Goff JM, Fiala LA, O'Donnell SD, Gomperts ED, Navalta LA, Hestlow T, Alving BM. Hemostatic efficacy of fibrin sealant (human) on expanded poly-tetrafluoroethylene carotid patch angioplasty: a randomized clinical trial. J Vasc Surg. 1999 Sep;30(3):461-6. doi: 10.1016/s0741-5214(99)70073-x.
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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.
Hardy Schumacher, Prof. Dr. study chair
Klinikum Hanau GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lyostypt® AND Surgicel®, Lyostypt® and Surgicel® in people with Peripheral Vascular Diseases and Hemostasis, run by Aesculap AG at 1 site in Germany.
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 3 inclusion and 12 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to hemostasis (time frame: Minutes). 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 NCT00837954, which also lists 28 linked publications.
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 28 May 2015.