HemorrhageIVC CLAMPNCT00732979
Infrahepatic Inferior Vena Cava Clamping During Hepatectomy
A study testing Infrahepatic inferior vena cava clamping and No infrahepatic inferior vena cava clamping in people with Hemorrhage, run by Heidelberg University at 1 site in Germany.
Trial summary
Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Infrahepatic inferior vena cava clamping and No infrahepatic inferior vena cava clamping
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Dec 2011
- Phase
- Interventional
- 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
- Aged 18 years
- Scheduled for elective hepatic resection due to any reason
- American Society of Anesthesiologists (ASA) score I to III
- Written informed consent
Who cannot join
- Medical conditions exposing patient at increased risk for not tolerating liver resection:
- Cirrhosis (Child-Pugh B and C)
- (Hereditary) coagulopathy
- Medical conditions exposing patient at increased risk for not tolerating this trial's study interventions:
- Severe heart disease (e.g. severe CAD requiring intervention, NYHA IV)
- Pulmonary hypertension
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- Renal insufficiency (serum creatinin >2mg/dl or >177µmol/l; conversion factor 88.4 or requiring dialysis)
- Severe hypernatremia (serum sodium >155mmol/l)
- Severe hyperchloremia
- For female subjects: pregnancy and lactation
- Impaired mental state or language problems
- Participation in other clinical trials or observation period of competing trials interfering with the endpoints of this trial
- Former participation in the clinical trial
- Expected lack of compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg, 69120
About this study
Official title: IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial
Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. While CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair organ function. Moreover, it may lead to hemodynamic instability, particularly in case of severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping has been suggested which is able to lower CVP without the need for fluid restriction.
In the present study the two strategies to reduce CVP and by this intraoperative bleeding, namely fluid restriction and inferior vena cava clamping are compared with intraoperative blood loss as primary endpoint.
- Conditions
- Hemorrhage
- Being tested
- Infrahepatic inferior vena cava clamping, No infrahepatic inferior vena cava clamping
- Keywords
- Elective, hepatic, resection, due to any, reason.
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrahepatic inferior vena cava clampingProcedure or surgery
The inferior vena cava is circumferentially dissected below the liver and clamped with a vascular clamp. Patients in this study group will receive intravenous volume for maintenance of fluid hemostasis according to local standards.
No infrahepatic inferior vena cava clampingProcedure or surgery
Patients in this study group undergo hepatic resection following current standards of the Departments of Surgery and Anesthesiology, University of Heidelberg. Current practice consists of no type of vascular control in combination with CVP reduction below < 5mmHg. CVP reduction is mainly attained using restricted intravenous fluid administration.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Infrahepatic inferior vena cava clamping The inferior vena cava is circumferentially dissected below the liver and clamped with a vascular clamp. Patients in this study group will receive intravenous volume for maintenance of fluid hemostasis according to local standards. Receives: Procedure: Infrahepatic inferior vena cava clamping |
| B | Active comparator | Patients in this study group undergo hepatic resection following current standards of the Departments of Surgery and Anesthesiology, University of Heidelberg. Current practice consists of no type of vascular control in combination with CVP reduction below < 5mmHg. CVP reduction is mainly attained using restricted intravenous fluid administration. Receives: Procedure: No infrahepatic inferior vena cava clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Measured: End of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuh Rahbari, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732979
- Sponsor's protocol ID
- NNR-01
- Acronym
- IVC CLAMP
- Status last verified
- May 2013
- First submitted
- 7 Aug 2008
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rahbari NN, Koch M, Zimmermann JB, Elbers H, Bruckner T, Contin P, Reissfelder C, Schmidt T, Weigand MA, Martin E, Buchler MW, Weitz J. Infrahepatic inferior vena cava clamping for reduction of central venous pressure and blood loss during hepatic resection: a randomized controlled trial. Ann Surg. 2011 Jun;253(6):1102-10. doi: 10.1097/SLA.0b013e318214bee5.
PubMed 21412143Rahbari NN, Zimmermann JB, Koch M, Bruckner T, Schmidt T, Elbers H, Reissfelder C, Weigand MA, Buchler MW, Weitz J. IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy--a randomised controlled trial in an interdisciplinary setting. Trials. 2009 Oct 13;10:94. doi: 10.1186/1745-6215-10-94.
PubMed 19825186
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00732979
- Acronym / sponsor ID
- IVC CLAMP / NNR-01
- Conditions
- Hemorrhage
- Keywords
- Elective, hepatic, resection, due to any, reason.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Aug 2008 (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.
Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. While CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair organ function. Moreover, it may lead to hemodynamic instability, particularly in case of severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping has been suggested which is able to lower CVP without the need for fluid restriction.
In the present study the two strategies to reduce CVP and by this intraoperative bleeding, namely fluid restriction and inferior vena cava clamping are compared with intraoperative blood loss as primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Infrahepatic inferior vena cava clampingInfrahepatic inferior vena cava clamping The inferior vena cava is circumferentially dissected below the liver and clamped with a vascular clamp. Patients in this study group will receive intravenous volume for maintenance of fluid hemostasis according to local standards. |
| B | Active comparator | Procedure: No infrahepatic inferior vena cava clampingPatients in this study group undergo hepatic resection following current standards of the Departments of Surgery and Anesthesiology, University of Heidelberg. Current practice consists of no type of vascular control in combination with CVP reduction below < 5mmHg. CVP reduction is mainly attained using restricted intravenous fluid administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years
- Scheduled for elective hepatic resection due to any reason
- American Society of Anesthesiologists (ASA) score I to III
- Written informed consent
Key exclusion criteria (14 listed)
- Medical conditions exposing patient at increased risk for not tolerating liver resection:
- Cirrhosis (Child-Pugh B and C)
- (Hereditary) coagulopathy
- Medical conditions exposing patient at increased risk for not tolerating this trial's study interventions:
- Severe heart disease (e.g. severe CAD requiring intervention, NYHA IV)
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 |
|---|---|---|
| Infrahepatic inferior vena cava clampingThe inferior vena cava is circumferentially dissected below the liver and clamped with a vascular clamp. Patients in this study group will receive intravenous volume for maintenance of fluid hemostasis according to local standards. | Procedure or surgery | A |
| No infrahepatic inferior vena cava clampingPatients in this study group undergo hepatic resection following current standards of the Departments of Surgery and Anesthesiology, University of Heidelberg. Current practice consists of no type of vascular control in combination with CVP reduction below < 5mmHg. CVP reduction is mainly attained using restricted intravenous fluid administration. | Procedure or surgery | B |
Primary outcome
Intraoperative blood loss
Time frame: End of operation
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 17 May 2013.
- Derived from this study: PubMed 21412143Rahbari NN, Koch M, Zimmermann JB, Elbers H, Bruckner T, Contin P, Reissfelder C, Schmidt T, Weigand MA, Martin E, Buchler MW, Weitz J. Infrahepatic inferior vena cava clamping for reduction of central venous pressure and blood loss during hepatic resection: a randomized controlled trial. Ann Surg. 2011 Jun;253(6):1102-10. doi: 10.1097/SLA.0b013e318214bee5.
- Derived from this study: PubMed 19825186Rahbari NN, Zimmermann JB, Koch M, Bruckner T, Schmidt T, Elbers H, Reissfelder C, Weigand MA, Buchler MW, Weitz J. IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy--a randomised controlled trial in an interdisciplinary setting. Trials. 2009 Oct 13;10:94. doi: 10.1186/1745-6215-10-94.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrahepatic inferior vena cava clamping and No infrahepatic inferior vena cava clamping in people with Hemorrhage, run by Heidelberg University 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 4 inclusion and 14 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 17 May 2013. 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.
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?
Intraoperative blood loss (time frame: End of operation). 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 NCT00732979, which also lists 2 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 17 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.