Platelet DysfunctionNCT01382134
Effect of Aspirin, Hemodilution and Desmopressin on Platelet Dysfunction
A study testing Aspirin, desmopressin in people with Platelet Dysfunction and Hemodilution, run by The University of Hong Kong at 1 site in China.
Trial summary
Study hypothesis: Desmopressin (DDAVP) can improve platelet function under influence of aspirin, hemodilution and mild hypothermia Mild hypothermia (34-35oC) is known to cause platelet dysfunction. This could lead to increased surgical bleeding and increased transfusion requirement during surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Dysfunction, Hemodilution, Mild Hypothermia
- What is being tested?
- Aspirin, desmopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Sep 2013
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 60 adult Chinese subjects aged 18-60 without known platelet disorder, thrombocytopenia, history of taking drugs that may affect platelet function including herbal preparations.
Who cannot join
- Any known platelet or coagulation disorder
- Expected surgical operation or dental treatment within one week of scheduled drug intake.
- Known peptic ulcer disease
- Obesity (BMI >=30)
- Pregnant or lactating women.
- Known chronic liver or renal disease.
Show all 11Show fewer
- Coronary artery, carotid artery or peripheral artery disease
- Recent history of taking antiplatelet drugs, anticoagulants or herbal preparations.
- Smoker or alcohol user
- Mentally incapable of providing informed consent
- Students or junior staff members who had direct working relationship with the PI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aspirin, in Vitro Hemodilution and Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers
Study hypothesis: Desmopressin (DDAVP) can improve platelet function under influence of aspirin, hemodilution and mild hypothermia
Mild hypothermia (34-35oC) is known to cause platelet dysfunction. This could lead to increased surgical bleeding and increased transfusion requirement during surgery. Although this hypothermia-induced platelet dysfunction seems to be reversible with warming, this is not always possible or desirable.
Read more
Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a recent study, we have found that subcutaneous injection of 1.5 mcg (1/10th the usual dose) is already sufficient to fully reverse the platelet dysfunction seen at 32oC. We have demonstrated in another study that prolongation of the bleeding time in a 20% hemodiluted sample predicts increased postoperative bleeding after total knee replacement.
We have therefore designed this study as a follow up to our last two studies on DDAVP and hypothermia, to investigate whether hemodilution affects hypothermia induced platelet dysfunction and the response to DDAVP. In addition, another common cause of perioperative platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients. Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response to DDAVP, will also be investigated.
Read the detailed description
Mild hypothermia (34-35oC) is known to cause platelet dysfunction. Increased surgical bleeding and increased transfusion requirement at this temperature range has been reported in both cardiac and noncardiac surgeries. This degree of hypothermia is common during any general anaesthesia, particularly during surgeries which invlove major fluid shift and large area exposure of patients, e.g. trauma and burn patients.
Although this hypothermia-induced platelet dysfunction seems to be reversible with warming, warming is not always possible or desirable. During major trauma or burn surgery, surface warming of patient is practically difficult. During surgeries with major blood loss and fluid shift, heat loss usually occurs at a rate that is more rapid than any warming device can catch up with. During neurosurgery, cooling may be beneficial to neurological outcome.
Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a previous in vitro study, we have found that desmopressin significantly improves platelet function at 32oC. The improvement is seen with a very low concentration of desmopressin in vitro, which suggests that probably doses much smaller than the "standard dose" (15 mcg slow iv or subcutaneous) may be useful. In keeping with this in vitro study, in a more recent study, we have found that subcutaneous injection of 1.5 mcg (1/10th the usual dose) is already sufficient to fully reverse the platelet dysfunction seen at 32oC.
One of the limitations of our previous two studies is that the degree of platelet dysfuction observed at 32oC is relatively mild, with only around 20% prolongation of the closure times on the PFA-100® platelet function analyser. The clinical significance of such prolongation remains uncertain. However, we have demonstrated previously in another study that prolongation of the closure time to >188 sec in a 20% hemodiluted sample predicts increased postoperative bleeding after total knee replacement. We have therefore designed this study as a follow up to our last two studies on DDAVP and hypothermia, to investigate whether hemodilution affects hypothermia induced platelet dysfunction and the response to DDAVP.
In addition, another common cause of perioperative platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients. Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response to DDAVP, will also be investigated.
- Conditions
- Platelet Dysfunction, Hemodilution, Mild Hypothermia, NSAID, Desmopressin
- Being tested
- Aspirin, desmopressin, Placebo, desmopressin
- Keywords
- Platelet dysfunction, Hemodilution, Mild hypothermia, NSAID, Desmopressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin, desmopressinDrug
Aspirin 100mg daily for 3 days Desmopressin 15 microgram subcutaneously once only
Placebo, desmopressinDrug
Placebo 1 tab daily for 3 days Desmopressin 15 microgram subcutaneously once only
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Subjects will be given placebo daily for 3 days. On day 4 an early morning urine sample will be collected for detection of aspirin metabolite (11-dehydro thromboxane B2). On day 6 venous blood sample will be collected, 17mls before and 17 mls after injection of DDAVP 15 microgram subcutaneously. The blood samples will then be subjected for platelet function analysis. Receives: Drug: Placebo, desmopressin |
| Aspirin group | Active comparator | Subjects will be given aspirin 100mg daily for 3 days. On day 4 an early morning urine sample will be collected for detection of aspirin metabolite (11-dehydro thromboxane B2). On day 6 venous blood sample will be collected, 17mls before and 17 mls after injection of DDAVP 15microgram subcutaneously. The blood samples will then be subjected for platelet function analysis. Receives: Drug: Aspirin, desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function
Venous blood sample will be taken from subjects before and after injection of DDAVP. Blood sample will be subjected to: (i) complete blood count, (ii) PFA-100 platelet function analyzer, (iii) fibrinogen, and (iv) vWF:Ag concentration for analysis.
Measured: Day 6 after aspirin intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Platelet DysfunctionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsui Pui Yee, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382134
- Sponsor's protocol ID
- UW 11-075
- Status last verified
- Nov 2013
- First submitted
- 23 Jun 2011
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wolberg AS, Meng ZH, Monroe DM 3rd, Hoffman M. A systematic evaluation of the effect of temperature on coagulation enzyme activity and platelet function. J Trauma. 2004 Jun;56(6):1221-8. doi: 10.1097/01.ta.0000064328.97941.fc.
PubMed 15211129Cavallini M, Baruffaldi Preis FW, Casati A. Effects of mild hypothermia on blood coagulation in patients undergoing elective plastic surgery. Plast Reconstr Surg. 2005 Jul;116(1):316-21; discussion 322-3. doi: 10.1097/01.prs.0000170798.45679.7a.
PubMed 15988284Michelson AD, Barnard MR, Khuri SF, Rohrer MJ, MacGregor H, Valeri CR. The effects of aspirin and hypothermia on platelet function in vivo. Br J Haematol. 1999 Jan;104(1):64-8. doi: 10.1046/j.1365-2141.1999.01146.x.
PubMed 10027713Hofer CK, Worn M, Tavakoli R, Sander L, Maloigne M, Klaghofer R, Zollinger A. Influence of body core temperature on blood loss and transfusion requirements during off-pump coronary artery bypass grafting: a comparison of 3 warming systems. J Thorac Cardiovasc Surg. 2005 Apr;129(4):838-43. doi: 10.1016/j.jtcvs.2004.07.002.
PubMed 15821652Schmied H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet. 1996 Feb 3;347(8997):289-92. doi: 10.1016/s0140-6736(96)90466-3.
PubMed 8569362Winkler M, Akca O, Birkenberg B, Hetz H, Scheck T, Arkilic CF, Kabon B, Marker E, Grubl A, Czepan R, Greher M, Goll V, Gottsauner-Wolf F, Kurz A, Sessler DI. Aggressive warming reduces blood loss during hip arthroplasty. Anesth Analg. 2000 Oct;91(4):978-84. doi: 10.1097/00000539-200010000-00039.
PubMed 11004060Schmied H, Schiferer A, Sessler DI, Meznik C. The effects of red-cell scavenging, hemodilution, and active warming on allogenic blood requirements in patients undergoing hip or knee arthroplasty. Anesth Analg. 1998 Feb;86(2):387-91. doi: 10.1097/00000539-199802000-00032.
PubMed 9459254Todd MM, Hindman BJ, Clarke WR, Torner JC; Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) Investigators. Mild intraoperative hypothermia during surgery for intracranial aneurysm. N Engl J Med. 2005 Jan 13;352(2):135-45. doi: 10.1056/NEJMoa040975.
PubMed 15647576Ying CL, Tsang SF, Ng KF. The potential use of desmopressin to correct hypothermia-induced impairment of primary haemostasis--an in vitro study using PFA-100. Resuscitation. 2008 Jan;76(1):129-33. doi: 10.1016/j.resuscitation.2007.07.009. Epub 2007 Aug 21.
PubMed 17714852Ng KF, Lawmin JC, Tsang SF, Tang WM, Chiu KY. Value of a single preoperative PFA-100 measurement in assessing the risk of bleeding in patients taking cyclooxygenase inhibitors and undergoing total knee replacement. Br J Anaesth. 2009 Jun;102(6):779-84. doi: 10.1093/bja/aep091. Epub 2009 May 2.
PubMed 19411670Gallinaro L, Cattini MG, Sztukowska M, Padrini R, Sartorello F, Pontara E, Bertomoro A, Daidone V, Pagnan A, Casonato A. A shorter von Willebrand factor survival in O blood group subjects explains how ABO determinants influence plasma von Willebrand factor. Blood. 2008 Apr 1;111(7):3540-5. doi: 10.1182/blood-2007-11-122945. Epub 2008 Feb 1.
PubMed 18245665Mannucci PM, Capoferri C, Canciani MT. Plasma levels of von Willebrand factor regulate ADAMTS-13, its major cleaving protease. Br J Haematol. 2004 Jul;126(2):213-8. doi: 10.1111/j.1365-2141.2004.05009.x.
PubMed 15238142Tsui PY, Cheung CW, Lee Y, Leung SW, Ng KF. The effectiveness of low-dose desmopressin in improving hypothermia-induced impairment of primary haemostasis under influence of aspirin - a randomized controlled trial. BMC Anesthesiol. 2015 May 28;15:80. doi: 10.1186/s12871-015-0061-5.
PubMed 26017715
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aspirin, in Vitro Hemodilution and Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01382134
- Acronym / sponsor ID
- UW 11-075
- Conditions
- Platelet Dysfunction, Hemodilution, Mild Hypothermia, NSAID, Desmopressin
- Keywords
- Platelet dysfunction, Hemodilution, Mild hypothermia, NSAID, Desmopressin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Jun 2011 (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.
Study hypothesis: Desmopressin (DDAVP) can improve platelet function under influence of aspirin, hemodilution and mild hypothermia
Mild hypothermia (34-35oC) is known to cause platelet dysfunction. This could lead to increased surgical bleeding and increased transfusion requirement during surgery. Although this hypothermia-induced platelet dysfunction seems to be reversible with warming, this is not always possible or desirable.
Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a recent study, we have found that subcutaneous injection of 1.5 mcg (1/10th the usual dose) is already sufficient to fully reverse the platelet dysfunction seen at 32oC. We have demonstrated in another study that prolongation of the bleeding time in a 20% hemodiluted sample predicts increased postoperative bleeding after total knee replacement.
We have therefore designed this study as a follow up to our last two studies on DDAVP and hypothermia, to investigate whether hemodilution affects hypothermia induced platelet dysfunction and the response to DDAVP. In addition, another common cause of perioperative platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients. Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response to DDAVP, will also be investigated.
Detailed description
Mild hypothermia (34-35oC) is known to cause platelet dysfunction. Increased surgical bleeding and increased transfusion requirement at this temperature range has been reported in both cardiac and noncardiac surgeries. This degree of hypothermia is common during any general anaesthesia, particularly during surgeries which invlove major fluid shift and large area exposure of patients, e.g. trauma and burn patients.
Although this hypothermia-induced platelet dysfunction seems to be reversible with warming, warming is not always possible or desirable. During major trauma or burn surgery, surface warming of patient is practically difficult. During surgeries with major blood loss and fluid shift, heat loss usually occurs at a rate that is more rapid than any warming device can catch up with. During neurosurgery, cooling may be beneficial to neurological outcome.
Desmopressin (DDAVP) is a drug which has proven efficacy in improving platelet function in uraemic and cirrhosis patients, and in reducing blood loss in selected surgeries. In a previous in vitro study, we have found that desmopressin significantly improves platelet function at 32oC. The improvement is seen with a very low concentration of desmopressin in vitro, which suggests that probably doses much smaller than the "standard dose" (15 mcg slow iv or subcutaneous) may be useful. In keeping with this in vitro study, in a more recent study, we have found that subcutaneous injection of 1.5 mcg (1/10th the usual dose) is already sufficient to fully reverse the platelet dysfunction seen at 32oC.
One of the limitations of our previous two studies is that the degree of platelet dysfuction observed at 32oC is relatively mild, with only around 20% prolongation of the closure times on the PFA-100® platelet function analyser. The clinical significance of such prolongation remains uncertain. However, we have demonstrated previously in another study that prolongation of the closure time to >188 sec in a 20% hemodiluted sample predicts increased postoperative bleeding after total knee replacement. We have therefore designed this study as a follow up to our last two studies on DDAVP and hypothermia, to investigate whether hemodilution affects hypothermia induced platelet dysfunction and the response to DDAVP.
In addition, another common cause of perioperative platelet dysfunction is the intake of COX inhibitors, particularly aspirin by patients. Therefor the effect of aspirin on hypothermia induced platelet dysfunction and the response to DDAVP, will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Placebo, desmopressinSubjects will be given placebo daily for 3 days. On day 4 an early morning urine sample will be collected for detection of aspirin metabolite (11-dehydro thromboxane B2). On day 6 venous blood sample will be collected, 17mls before and 17 mls after injection of DDAVP 15 microgram subcutaneously. The blood samples will then be subjected for platelet function analysis. |
| Aspirin group | Active comparator | Drug: Aspirin, desmopressinSubjects will be given aspirin 100mg daily for 3 days. On day 4 an early morning urine sample will be collected for detection of aspirin metabolite (11-dehydro thromboxane B2). On day 6 venous blood sample will be collected, 17mls before and 17 mls after injection of DDAVP 15microgram subcutaneously. The blood samples will then be subjected for platelet function analysis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 60 adult Chinese subjects aged 18-60 without known platelet disorder, thrombocytopenia, history of taking drugs that may affect platelet function including herbal preparations.
Key exclusion criteria (11 listed)
- Any known platelet or coagulation disorder
- Expected surgical operation or dental treatment within one week of scheduled drug intake.
- Known peptic ulcer disease
- Obesity (BMI >=30)
- Pregnant or lactating women.
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 |
|---|---|---|
| Aspirin, desmopressinAspirin 100mg daily for 3 days Desmopressin 15 microgram subcutaneously once only | Drug | Aspirin group |
| Placebo, desmopressinPlacebo 1 tab daily for 3 days Desmopressin 15 microgram subcutaneously once only | Drug | Placebo group |
Primary outcome
Platelet function
Time frame: Day 6 after aspirin intake
Venous blood sample will be taken from subjects before and after injection of DDAVP. Blood sample will be subjected to: (i) complete blood count, (ii) PFA-100 platelet function analyzer, (iii) fibrinogen, and (iv) vWF:Ag concentration for analysis.
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 15 Nov 2013.
- Background: PubMed 15211129Wolberg AS, Meng ZH, Monroe DM 3rd, Hoffman M. A systematic evaluation of the effect of temperature on coagulation enzyme activity and platelet function. J Trauma. 2004 Jun;56(6):1221-8. doi: 10.1097/01.ta.0000064328.97941.fc.
- Background: PubMed 15988284Cavallini M, Baruffaldi Preis FW, Casati A. Effects of mild hypothermia on blood coagulation in patients undergoing elective plastic surgery. Plast Reconstr Surg. 2005 Jul;116(1):316-21; discussion 322-3. doi: 10.1097/01.prs.0000170798.45679.7a.
- Background: PubMed 10027713Michelson AD, Barnard MR, Khuri SF, Rohrer MJ, MacGregor H, Valeri CR. The effects of aspirin and hypothermia on platelet function in vivo. Br J Haematol. 1999 Jan;104(1):64-8. doi: 10.1046/j.1365-2141.1999.01146.x.
- Background: PubMed 15821652Hofer CK, Worn M, Tavakoli R, Sander L, Maloigne M, Klaghofer R, Zollinger A. Influence of body core temperature on blood loss and transfusion requirements during off-pump coronary artery bypass grafting: a comparison of 3 warming systems. J Thorac Cardiovasc Surg. 2005 Apr;129(4):838-43. doi: 10.1016/j.jtcvs.2004.07.002.
- Background: PubMed 8569362Schmied H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet. 1996 Feb 3;347(8997):289-92. doi: 10.1016/s0140-6736(96)90466-3.
- Background: PubMed 11004060Winkler M, Akca O, Birkenberg B, Hetz H, Scheck T, Arkilic CF, Kabon B, Marker E, Grubl A, Czepan R, Greher M, Goll V, Gottsauner-Wolf F, Kurz A, Sessler DI. Aggressive warming reduces blood loss during hip arthroplasty. Anesth Analg. 2000 Oct;91(4):978-84. doi: 10.1097/00000539-200010000-00039.
- Background: PubMed 9459254Schmied H, Schiferer A, Sessler DI, Meznik C. The effects of red-cell scavenging, hemodilution, and active warming on allogenic blood requirements in patients undergoing hip or knee arthroplasty. Anesth Analg. 1998 Feb;86(2):387-91. doi: 10.1097/00000539-199802000-00032.
- Background: PubMed 15647576Todd MM, Hindman BJ, Clarke WR, Torner JC; Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) Investigators. Mild intraoperative hypothermia during surgery for intracranial aneurysm. N Engl J Med. 2005 Jan 13;352(2):135-45. doi: 10.1056/NEJMoa040975.
- Background: PubMed 17714852Ying CL, Tsang SF, Ng KF. The potential use of desmopressin to correct hypothermia-induced impairment of primary haemostasis--an in vitro study using PFA-100. Resuscitation. 2008 Jan;76(1):129-33. doi: 10.1016/j.resuscitation.2007.07.009. Epub 2007 Aug 21.
- Background: PubMed 19411670Ng KF, Lawmin JC, Tsang SF, Tang WM, Chiu KY. Value of a single preoperative PFA-100 measurement in assessing the risk of bleeding in patients taking cyclooxygenase inhibitors and undergoing total knee replacement. Br J Anaesth. 2009 Jun;102(6):779-84. doi: 10.1093/bja/aep091. Epub 2009 May 2.
- Background: PubMed 18245665Gallinaro L, Cattini MG, Sztukowska M, Padrini R, Sartorello F, Pontara E, Bertomoro A, Daidone V, Pagnan A, Casonato A. A shorter von Willebrand factor survival in O blood group subjects explains how ABO determinants influence plasma von Willebrand factor. Blood. 2008 Apr 1;111(7):3540-5. doi: 10.1182/blood-2007-11-122945. Epub 2008 Feb 1.
- Background: PubMed 15238142Mannucci PM, Capoferri C, Canciani MT. Plasma levels of von Willebrand factor regulate ADAMTS-13, its major cleaving protease. Br J Haematol. 2004 Jul;126(2):213-8. doi: 10.1111/j.1365-2141.2004.05009.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.
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 Aspirin, desmopressin in people with Platelet Dysfunction and Hemodilution, run by The University of Hong Kong at 1 site in China.
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 1 inclusion and 11 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 15 Nov 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 China. 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. Some participants in this study may receive a placebo. 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?
Platelet function (time frame: Day 6 after aspirin intake). 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 NCT01382134, which also lists 13 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 15 Nov 2013.